cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating Renal Cell Carcinoma Risk Factors

This is an epidemiological, prospective, multicenter study designed to identify the pre-treatment clinical, molecular and genetic prognostic factors associated with progression free survival in patients naïve to renal cell carcinoma (RCC) treatment.

invitation to volunteer

Eligibility Criteria:
Inclusion Criteria:

* Treatment naïve patients with proven advanced RCC will be evaluated. (Except surgery or radiotherapy)
* =18 years, any gender.
* Patients with advanced Renal Cell Carcinoma and treatment naïve.

Exclusion Criteria:

* Patients who have already initiated any kind of specific therapy for the treatment of RCC.2.
* Patients with other neoplasias different from RCC (current or past).
Effect of Pioglitazone on Testosterone in Eugonadal Men With Type 2 Diabetes Mellitus - A Pilot Study

To study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.

Several clinical studies demonstrated that pioglitazone not only improves insulin sensitivity but also decreases plasma androgen concentrations (DHEAS and androstenedione) in women with polycystic ovary syndrome (PCOS) . However the reduction in the androgen levels in PCOS is whether secondary to increase in the insulin sensitivity or due to direct effect of thiazolidinediones on steroidogenesis is not known.So far, two human studies have been conducted regarding the effects of rosiglitazone (a thiazolidinedione group of drug) on testosterone level, one in healthy individuals and another was in patients of type 2 diabetes with hypogonadism . But these studies gave equivocal results as the study population were different. Hence we plan to study the effects of pioglitazone on the steroidogenic enzyme axis in eugonadal men with type 2 diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* HbA1c level of 7.5% or less on stable dosages of sulphonylurea (glimepiride 1-6mg/day) and metformin (1-2g/day) for at least six weeks and BMI of 20-30 kg/m2.

Exclusion Criteria:

* hepatic impairment, coronary artery disease and or heart failure, renal failure, those who requires insulin therapy or HbA1c \>7.5%, presence of macular edema and serum albumin \<3gm/dL.
Ultrasound Assessment of the Anatomic Landmarks for Spinal Anesthesia in Patients With Hip Fracture

Investigators assess the anatomic landmarks for spinal anesthesia in patients with hip fracture using ultrasonography.

Investigators evaluate the anatomic landmarks using Tuffier's line and the tenth rib line for spinal anesthesia in patients with hip fracture, and then assess the consistency of the landmarks-guided interspinous levels with the actual interspinous level using ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for hip fracture surgery under spinal anesthesia

Exclusion Criteria:

* Anatomic abnormalities or masses in the spine
* History of spinal surgery of compression fracture
Low Back Pain and Quality of Life Among the Ambulance Drivers in Malaysia's Hospitals

The study is a community interventional study by using an integrated back pain module (IBPM). The purpose of this study is to find out if the module training has any benefit on Low Back pain among ambulance drivers. The effectiveness of the module is determined by baseline quality of life results compared with after the intervention program completed.

An integrated back pain module (IBPM) will be implemented for ambulance drivers (Respondent) in peninsular Malaysia. Pre-intervention assessment and post-intervention assessment will be conducted in 18 government hospitals involved. There is nine Hospital in Perak that has been selected as an intervention group and nine Hospital in Kelantan will be the Control group. Two different regions are selected; the North region will be the intervention group (Perak) while East Coast will be the control group (Kelantan). The clinical benefits of the IBPM module low back pain and quality of life will be reported at the beginning and the end of the intervention and after a period of 6 months follow up.

The protocol for the intervention group (Perak) included five components of the education module (IBPM) such as the structure and function of the spine, causes of LBP, how to avoid low back pain at the workplace, Exercise methods, and psychology management. The overall objectives are to help ambulance driver manage their LBP and prevent future LBP recurrences. The first step of the protocol is subjects are required to attend an introductory course for one day and then the intervention will last for 6 months. Research staff will explain how to operate and use the module. Subjects must comply with all the care and prevention guidelines of the research module so that it achieves the expected results. They also need to complete the checklist provided in the Edmodo software via their respective smartphones. Tokens in the form of top-ups will be entered automatically after the checklist is received by researchers.

The exercise will be performed by participants 5 times per week for a total of 24 weeks. Each individual session will take around 5 minutes to perform exercises independently and sending their report through Edmodo. Light soft tissue exercises techniques such as active muscle stretching, and strengthening exercises will be used as needed to facilitate the educational module therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years old.
* Working experience ≥ 1 year

Exclusion Criteria:

* Patients with Uncontrolled Chronic Illness such as Hypertension, Diabetes Mellitus, Osteoarthritis and Gout.
* Injury or surgery of the spine
Refining the Target for Deep Brain Stimulation (DBS) in Severe, Treatment Refractory Obsessive Compulsive Disorder (OCD)

In select, therapy resistent patients with Obsessive Compulsive Disorder (OCD) Deep Brain Stimulation (DBS) has been used as a treatment. DBS is a therapy modality in which electrodes are implanted within specific sub-structures of the brain in order to modulate the activity in targeted neural circuits associated with different neurological disorders. The results of this novel approach to psychiatric disorders have been optimistic. This study aims to investigate wether or not the distance to target location has an influence on the outcome.

In order to deliver DBS, leads containing four electrodes are implanted into the brain target in the ventral capsule/ventral striatum (VC/VS). After an optimization period, patients enter a triple blind randomised two fazed crossover design of two periods of three months. In both crossover branches, patients, evaluating psychiatrist and psychologist are blinded for the stimulation conditions. These conditions are stimulation ON (at optimal parameters) and stimulation OFF. Stimulation parameters are constant during the entire period. During the second crossover branch, stimulation conditions are reversed for all patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD (300.3).
* Failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for OCD.
* Failure of documented trial of cognitive and behavioural therapy
* Duration of illness: min. 5 year
* Y-BOCS at least 30/40.
* Age: 20-65 year

Exclusion Criteria:

* DSM-IV diagnosis on axis 2 of severe personality disorder in cluster A or B, especially in the case of heightened risk for acting-out behavior.
* DSM-IV diagnosis on axis 3 of organic brain pathology or significant abnormalities on MRI.
* Present or past history of psychotic symptoms.
* Present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months).
* Any disorder affecting cognitive functioning, other than motor tics and Gilles de la Tourette's Syndrome
* Mental retardation. A minimum threshold of cognitive skills is needed for adequate reporting on questionnaires and evaluation, and for technical handling of the instruments in a later faze.
* The patient must be juridical free.
Does Prescriptive Treatment of the Hips Improve Outcomes in Patients With Low Back Pain? A Randomized Controlled Trial

There will be two groups of patients with low back pain (by randomization). Both groups will receive a pragmatic treatment approach by physical therapists for low back pain. One group will also receive a prescriptive treatment approach for both hips. The investigators feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

It has been suggested that treatment of the hips should improve outcomes in patients with mechanical low back pain. This has yet to be studied in a randomized controlled fashion or in a conservative venue. For this study, there will be two groups of patients with low back pain (by randomization). For inclusion into the randomized clinical trial, patients will need to be 18 years of age or older with mechanically producible LBP. They will require a minimum Modified Oswestry Disability Index score of 20% and a baseline pain score of \>2.0/10 on the numeric analog scale for pain, and a within session change (improvement during the visit) in pain and/or range of motion during the assessment phase of the clinical examination. This finding has been advocated as an effective mechanism to determine if a patient is a candidate for manual therapy. Exclusion criteria will include the presence of any red flags (i.e., tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). Other exclusion criteria include prior surgery to the lumbar spine and current pregnancy. Both groups will receive a pragmatic treatment approach by physical therapists for low back pain. One group will also receive a prescriptive treatment approach for both hips. The investigators will track the outcomes of disability (Oswestry), Pain (Numeric pain rating scale), and recovery at baseline, 2 weeks, and discharge. Our aims are to determine if differences in groups exist, with our primary outcome measure of ODI. The investigators feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Mechanically producible LBP.
* Minimum Modified Oswestry Disability Index score of 20%
* Minimum baseline pain score of \>2.0/10 on the numeric analog scale for pain

Exclusion Criteria:

* Presence of any red flags
* Signs consistent with nerve root compression
* Prior surgery to the lumbar spine
* Current pregnancy
Botulinum Toxin A Single Blind Split-Face Randomized Pilot Study

A 16-week single-blind, split-face, randomized study. Each patient served as their own control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or right side of the face. Patients received intradermal BTXA injections at week 0 and intramuscular BTXA injections at week 2. The objective is to examine the effectiveness of intradermal botulinum toxin type A (BTXA) injection in improving skin texture and midface lift while reducing pore size and sebum production, as well as investigate the differences in effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and intramuscular injection methods.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects between ages of 35 to 65 years (inclusive) who exhibit static wrinkles in the following areas: glabella (forehead frowns), periorbital area (crows feet). Static wrinkles in additional areas of the face are also acceptable.
* Subject is willing to maintain the same skin care regimen throughout the study and has already maintained this skin care regime for 4 weeks prior to baseline.
* The subject is able to comply with study procedures and instructions and is committed to attend all study visits within the given timelines.
* Subject is judged to be a good candidate by study nurse upon identification of dynamic and/or static wrinkles in the areas of movement, and with a moderate amount of skin laxity.
* Subject is willing to use contraception
* A signed informed consent form by a subject able to give consent, prior to any study procedures are performed.

Exclusion Criteria:

* Sensitivity and/or contraindications to botulinum toxin A other ingredients contained in the botulinum toxin A products.
* Any medical condition, in the opinion of the investigator, that would interfere with safety or any study procedures (e.g. auto-immune disease, history of severe allergies, hypertrophic scars, immunotherapeutic treatment, inflammatory or infectious complaints at injection sites, unable to give consent)
* Treatment with botulinum toxin A injections in the neck or face within 1 year of baseline treatment
* Treatment with facial fillers less than 1 year prior to baseline
* Females of childbearing potential who are pregnant, breastfeeding or plan to get pregnant during the course of the study.
* Previous treatment with Lasers, Ultrasound Technology or Radio Frequency on the face and/or neck within 1 year prior to baseline.
* Treatment with Accutane (isotretinoin) or other oral medications for acne during 1 year prior to baseline.
* The use of anti-aging products containing retinol
* Known allergy to cow's milk protein
Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences 2

This study is an ancillary of APPRENTICE. This will be the international based study.

This study is an ancillary of APPRENTICE. This will be the international based study. The initial study design with discussions about the different variables to be included into our prospective database started during 2014 PancreasFest held in Pittsburgh, PA in late July 2014 under the sponsorship of Collaborative Alliance for Pancreatic Education and Research (CAPER). Following this, a datasheet with variables was created, distributed through the initial participants, and further suggestions and edits were made. We now plan to move ahead with a web based seminar. All previous participants, as well as new investigators/centers that have shown interest in participating throughout the world will be invited.University of Pittsburgh will be responsible for collecting all required regulatory documents from other sites. Developing templates for questionnaires and other data collection forms. Will train approved sites on procedures. The coordinating center will be the recipient of de-identified data and will not be involved in the collection of data.

Note that copies of training records, licenses, certificates should be maintained in the study regulatory binder and are subject to audit by the Research Conduct and Compliance Office (RCCO).

Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of AP based upon presence of two out of the three following criteria:

   1. Abdominal pain typical to AP
   2. Serum amylase or lipase levels more than three times the upper limit of normal
   3. Imaging findings suggestive of AP
2. Willingness to participate in the study and ability to sign informed consent by patient or his/her proxy (if unable to speak).

Exclusion Criteria:

1. Age under 18 years
2. Unwilling to provide consent by patient or his/her proxy
3. Presence of pancreatic cancer
4. Presence of chronic pancreatitis
5. Occurrence of AP following a multiple trauma episode
6. Having history of organ transplant
7. Presence of any cancer which required chemotherapy or radiation therapy in the past year.
Natural History of Mineral Metabolism Parameters and Protein-bound Toxins in Incident Peritoneal Dialysis Patients

The aims of this study are

1. To evaluate the natural history of plasma concentrations and renal and peritoneal clearances of small water-soluble uremic retention molecules (URM), 'middle molecules', and protein bound URM in incident peritoneal dialysis (PD) patients.
2. To evaluate the natural history and determinants of the generation rate of URM originating from bacterial protein fermentation in PD patients.
3. To evaluate the natural history of biochemical parameters of mineral metabolism in incident PD patients.


Eligibility Criteria:
Inclusion Criteria:

* Incident PD patients, defined as patients who started on PD as first renal replacement therapy less than 8 weeks before inclusion
* written informed consent
* age \> 18 years old
Motivational Interviewing & Clinician Centered Interviewing on Cardiac Rehab

The purpose of this project is to examine the differences in outpatient cardiac rehab (OPCR) core component outcomes on different intervention conditions. Conditions include traditional OPCR (control), OPCR + motivational interviewing (MI) and OPCR + Clinician centered interviews.

Participants who are beginning a OPCR program at a local hospital are eligible for the program. During the standard admission procedures, eligible participants will be provided with a consent from and asked to participate in the study. Participants who provide consent will complete their admission packet. The standard admission packet includes: the Outpatient Fall Assessment Risk, Patient Health Questionnaire (PHQ-9),the Dartmouth Quality of Life, and the Rate Your Plate. In addition participants will complete three additional surveys: the Intrinsic Motivation Inventory (IMI), the FPS, (FACES Pain Scale), and the Brief Resilience Scale (BRS). During their second appointment participants will complete the standard 6 minute walk test which is scheduled at their convenience and the grip strength. Participants will then be randomly assigned to the traditional OPCR, the OPCR + MI, or the OPCR - Clinician centered. Post-testing will include all baseline information as well as information from patients charts (lipid profile, HbA1c, risk factors and family history). Analysis will determine differences in core outcomes between the three groups.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in outpatient cardiac rehab
* Able to complete the paperwork independently

Exclusion Criteria:

* Unable to complete assessments and paperwork independently.
Detemir Energy Expenditure Study

This is a study designed to compare the effects of 2 long-acting insulins, detemir and insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic control and fat and muscle gene expression over a 6 month period.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes
2. Treated with metformin
3. Already on treatment with a long-acting or intermediate insulin.
4. Over 18 years of age,
5. HbA1c \> 7.0%
6. BMI 27-40
7. Able and willing to perform self-blood glucose monitoring.
8. Able and willing to maintain consistent eating habits throughout the entire trial period.
9. Able and willing to maintain consistent physical activity level during the entire trial period

Exclusion Criteria:

1. Patients on sulphonylureas or thiazolidinediones
2. Proliferative retinopathy that has required acute treatment within the last six months.
3. Impaired hepatic or renal functions.
4. Cardiac problems.
5. Uncontrolled hypertension (treated or untreated).
6. Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.
The Altitude Inflammatory Bowel Disease Study

This is a prospective, controlled and observational study. Participants underwent a 3-hour exposure to hypoxic conditions simulating an altitude of 4,000 meters above sea level (m.a.s.l.) in a hypobaric pressure chamber. Clinical parameters, as well as blood and stool samples and biopsies from the sigmoid colon (by sigmoidoscopy) are collected at subsequent time points. The investigators goal is to evaluate if a 3-hour stay at high altitude (4, 000 m) can alter disease activity and can modulate a pro inflammatory reaction.

To evaluate the potential influence of hypoxia on the course of IBD on a biomolecular level, and to test the effects of hypoxia under standardized conditions, the investigators initiated a prospective and controlled investigation in healthy controls and IBD patients in stable remission. the investigators primary aim is to show that a 3-hour stay at high altitude can alter disease activity of IBD. Ten healthy volunteers, 11 Crohn's disease (CD) patients and 9 ulcerative colitis (UC) patients underwent a 3-hour exposure to hypoxic conditions simulating an altitude of 4,000 m.a.s.l. in a hypobaric low-pressure chamber situated at the Swiss Aeromedical Center, Dubendorf, Switzerland. Stool samples for the analysis of calprotectin and microbiotal composition, biopsy samples from the rectosigmoid region, and blood samples were repetitively collected and analysed in conjunction with detailed records of clinical symptoms over a subsequent interval of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* had a diagnosis of Crohn's disease or ulcerative colitis at least 6 months prior to inclusion
* gave written consent
* were in clinical remission (measured by Harvey Bradshaw Activity Index (HBI) in CD and the partial Mayo Score for UC)

Exclusion Criteria:

* had contraindications for a sigmoidoscopy
* had intercurrent bacterial or viral intestinal disease (by culture or serology)
* were pregnant or breast feeding
* had a severe concomitant disease which excluded from participating in the study by means of the study physician
* were likely to or showed no cooperation for the study procedures
* had active infection or systemic antibiotic, antiviral or antifungal treatment 3 weeks before baseline
* were suffering from short-bowel syndrome
* were receiving parenteral nutrition
* had a clinical condition which did not allow a stay at heights of 4,000 m.a.s.l.
* were claustrophobic
Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children

Evaluate the effect of probiotics on stool output in children 1 - 18 months old.

Evaluate the effect of probiotics on stool output in children 1 - 18 months old.

Eligibility Criteria:
Inclusion Criteria:

* children 1 - 18 months of age
* acute diarrhea
* adequately hydrated
* signed informed consent

Exclusion Criteria:

* exclusively or predominantly breast-feeding
* bloody diarrhea
* intercurrent illnesses that may affect study parameters
* use of systemic antibiotics during the 72 hours prior to enrollment
* use of anti-diarrheal medications at the time of enrollment
* use of supplement or infant formula with Lactobacillus rhamnosus 10 days prior to enrollment