cyrilzakka/clinical-trials huggingface dataset:
Progression From Impaired Fasting Glucose to Type 2 Diabetes Mellitus Among Subjects With and Without Hypertension in Primary Care Setting

Retrospective cohort of all the patients with elevated blood sugar (but no Diabetes) attending the study sites from 2002 to 2007. We retrieval their records to see how many of them actually developed diabetes. The patient's record will be followed up to 6 years after their first abnormally high blood sugar checked. We will measure their parameters including sex, age, pay code and whether they have hypertension or not to see what factors will increase risk of DM development.

We aim at find out the progression of impaired fasting glucose (IFG) to type 2 Diabetes Mellitus (T2DM) among patients in general practice setting. We can understand the progress of the target patients so as to improve patient education, improve patient motivation in lifestyle modification.We are going to find out the annual incidence of Type 2 DM developement among the patients with and without hypertension Hypertensive patients with impaired fasting glucose are more likely to develop type 2 diabetes mellitus compare with normal tensive patients

Eligibility Criteria:
Inclusion Criteria:We include all subjects age ≥18 attended the study centers with laboratory diagnosis of IFG by blood sugar 6.1 mmol/l to 6.9 mmol/l checked from 2002 to 2007 in the 6 study centres.

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Exclusion Criteria:We excluded the subjects who have diagnosis of T2DM the years prior to the year of blood taken. We define T2DM by physician coding ICPC-2 of T90 Diabetes non-insulin dependent or prescription of antidiabetic drugs (British National Formulary(23) (BNF) section 6.1 and 6.2). We exclude the patients who had been admitted to Hong Kong Hospital Authority (HKHA)or attended HKHA specialty Clinic, or attended any GOPC with dispensing history of drug used in diabetes in BNF Section 6.1.1 insulins or 6.1.2 anti-diabetic drugs, or with ICPC coded with T90) during 1 Jan 2005 - 31 Dec 2006 (i.e. 2 year prior to starting of study period). We also excluded patient with the date of diagnosis of DM by above criteria earlier than the date of laboratory test results of IFG.

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Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery

The main objective is to evaluate the impact of intestinal preparation on the composition, diversity and metabolome of the intestinal microbiota.

Based on the limited literature that PEG does not significantly impact the microbiome, certain investigators ascertain that administration of PEG without any subsequent FMT would represents the gold-standard control group. On the other hand, other investigators raised their concern that perturbation of the microbiome with PEG without subsequent replacement with FMT might negatively impact immune checkpoint inhibitor efficacy. Therefore, there is an unmet need to conduct a study using the metagenomic shotgun sequencing to precisely understand the impact of bowel preparation on gut microbiome composition and on the dynamics of recovery of the gut microbiome after bowel preparation to better design microbiome-centered trials.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer participant cohort:

  1. \> 18 years of age
  2. The participant has provided documented informed consent for the participation and to complete PEG bowel preparation and return collected stool samples.

Exclusion Criteria:

* An ileus
* Significant gastric retention
* Suspected or established mechanical bowel obstruction
* Inflammatory or infectious gastrointestinal condition
* Neurologic or cognitive impairment that prevents safe swallowing
* Recent history (\<1 year) of cancer that still requires ongoing treatment
* Recent use of antibiotics 1 month prior to participation in the trial
* History of cardiac disease
* History of active renal dysfunction
* Presence of any absolute contraindication to PEG bowel preparation according to manufacturer labeling
Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective

All heart surgery patients universally require hydration, which is given through a vein in the arm, but practices for treating patients are not universal. There are disagreements about whether crystalloids should be used alone or in combination with albumin. This question has important implications because albumin is an expensive blood product in relatively limited supply, and 20% of its use is by heart surgery patients. The goal of this study is to learn more about how crystalloids and albumin are used during heart surgery, as well as, key patient outcomes.

The goal of this proposed multicentre retrospective cohort study is to characterize perioperative usage patterns of crystalloids and albumin, as well as key patient outcomes, in cardiac surgical patients. This study will also address numerous other knowledge gaps in the area of perioperative blood product management and fluid administration in cardiac surgery and define a collaborative group to support future research in this field.

The primary objective is to obtain granular information on if, when, and how albumin is given perioperatively to cardiac surgical patients. This includes the doses and settings in which albumin is used, the types of crystalloid solutions (balanced or unbalanced) used, and when albumin is used (for example, while on cardio-pulmonary bypass, in the ICU, or on the ward) in perioperative cardiac surgical care across institutions. This important information about the scope of albumin and crystalloid use across the country will inform the design of our future intervention and control arms in the planned definitive trial.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years old)
* Cardiac surgery with the use of cardiopulmonary bypass
* Cardiac surgery without the use of cardiopulmonary bypass

Exclusion Criteria

* None
Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry

This is a study to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.

The degree of a relative afferent pupillary defect (RAPD) has been correlated with the severity of an eye injury and has been shown to have prognostic significance as an indicator of retinal ischemia. Therefore light flashed evoked pupillometry (LFEP) may serve as a useful indicator of visual function. LFEP's are not known to be sensitive to anesthetics. We will measure LFEP's using different anesthetic techniques to see if there are measurable differences in the latency, amplitude and constriction velocity of the pupillary reflex. Prior to induction of anesthesia, pupillometer readings will be taken in the supine position in both eyes. The patient will be anesthetised using a standard induction technique. For maintenance of anesthesia a remifentanil infusion will be administered and supplemented by either propofol infusion (at 120 and 160 mcg/kg/min)or sevoflurane (at 1.5 and 2.5% end-tidal in random sequence. The patients will receive muscle relaxants as needed. Pupillometry readings will be taken in both eyes after induction, after steady maintenance has been achieved and every 10 minutes for 30 minutes at each drug dose.

Eligibility Criteria:
Inclusion Criteria:

* planned orthopedic surgery on the lower extremities and positioned on the back

Exclusion Criteria:

* recent bout of conjunctivitis or pink eye
* condition which inhibits the normal pupillary function of my eye
Foreskin Graft Tubularized Incised Plate Urethroplasty vs Tubularized Incised Plate for Primary Hypospadias (FGTIP-TIP)

The purpose of this study is to determine the efficacy and safety of tubularized incised plate urethroplasty versus foreskin graft tubularized incised plate urethroplasty in primary hypospadias. This study only included patients with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.

Urethroplasty technique more used in the world for hypospadias repair is Tubularized Incised Plate described by Snodgrass in 1994. Kolon and Gonzales described a technical modification to the TIP in 2000, which is called grafting foreskin.

There are characteristics of the glans and urethral plate favoring the development of complications. In this study the researchers include patients with primary hypospadias, with these characteristics above, and compare two surgical techniques: TIP vs FG-TIP.

The main aim is to determine the efficacy (functional and cosmetic) and safety (complications) of TIP vs FG-TIP.

The study design is a randomized clinical trial, double blind (patient and evaluator), parallel groups.

The sample size was calculated comparing two proportions, with a alpha 0.05, beta 0.2; 34 patients per group. The main outcome is complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hypospadias without previous surgery
* Hypospadias with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.

Exclusion Criteria:

* Patients diagnosed with hypospadias and severe psychomotor development delay
* Patients with disorders of sexual development without gender assignment
Factors That Determine the Responses to Food Ingestion: Protein Load

Aim: to determine to what extent meal composition influences postprandial sensations. Experimental design: randomized cross-ower study comparing the responses to a high protein (47.3% protein, 39.4% carbohydrates, 13.3% lipids) versus a balanced (22.2% protein, 67.85% carbohydrates, 9.95% lipids). In each participant the meals (both containing 20.8 g protein and diluted to a volume of 200 mL) will be tested on separate days. Healthy, non-obese participants (8 men and 8 women) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion, at 10 min intervals up to 60 min after the meal and at 30 min up to 120 min after ingestion. Blood samples for biochemical and hormonal determinations will be taken before and after ingestion.


Eligibility Criteria:
Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders
AP-011 Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ for Arthritis of the Basal Thumb Joint

This study will evaluate the safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the basal thumb joint.

A prospective phase I study to evaluate the safety of a single intra-articular injection of Ampion™ as a treatment for arthritis of the basal thumb joint.

Primary Objective is:

To evaluate the safety of Ampion™ (up to 3 mL) in comparison to saline placebo (up to 3 mL) when injected into the basal thumb joint.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide written informed consent to participate in the study.
2. Willing and able to comply with all study requirements and instructions of the site study staff.
3. Male or female, 40 years to 85 years old (inclusive).
4. Radiographic evidence of Basal joint arthritis (Eaton-Littler classification, stages 1 through 4).
5. Pain associated with basal joint arthritis, defined as a score ≥ 4 as evaluated by the Australian-Canadian OA Index (AUSCAN)-numeric rating score (NRS, 0-10).

Exclusion Criteria:

1. As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study.
2. Previous Ampion™ injection.
3. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion).
4. A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
5. Women who are currently pregnant or who could become pregnant.
6. Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis, as assessed locally by the Principal Investigator.
7. Any other disease or condition interfering with the free use and evaluation of the index thumb for the duration of the trial (e.g., congenital defects, stricture).
8. Major injury to the index thumb within the 12 months prior to screening.
9. Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to treatment or likely to be changed during the duration of the study.
10. Use of the following medications are exclusionary:

    * IA injected pain medications in the study thumb during the study;
    * Analgesics containing opioids;
    * NSAIDs (including but not limited to ibuprofen, aspirin, naproxen, diclofenac) acetaminophen is available as a rescue medication during the study from the provided supply;
    * Topical prescription treatment on osteoarthritis index thumb during the study;
    * Significant anticoagulant therapy (e.g., Heparin or Lovenox) during the study (treatment such as Aspirin in the cardio-protective dose (81mg) and Plavix are allowed);
    * Systemic treatments that may interfere with safety or efficacy assessments during the study;
    * Immunosuppressants;
    * Use of corticosteroids \> 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable, defined as chronic use of the same dose for at least 1 month).
11. Any human albumin treatment in the 3 months before randomization.
Fulvestrant in Hormone Refractory Prostate Cancer

The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA).

The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA). In vitro studies have shown that fulvestrant downregulates androgen receptor (AR) in LNCaP cancer cell lines to a significant extent, thereby inhibiting growth of tumor cells. In addition, it is important to emphasize that fulvestrant has also been found to decrease growth of AR-negative prostate cancer cells. These observations provide the rational for using fulvestrant for the treatment of AIPC and HRPC.

Eligibility Criteria:
Inclusion Criteria:

* Must give signed written informed consent
* Must be of age 18 years or older
* Histologically confirmed adenocarcinoma of the prostate
* Must be currently receiving LHRH agonists and have castrate levels of testosterone or have had an orchiectomy
* Must have had rise in PSA despite anti-androgen withdrawal
* Must exhibit two consecutive rises in PSA after the last hormonal manipulation
* Minimum PSA \> 5mg/dL
* KPS \> 80%
* Up to one prior chemotherapy treatments allowed
* Life expectancy of greater than 6 months

Exclusion Criteria:

* Concomitant hormonal therapy other than an LHRH
* Noncompliance
* Platelets less than 100 x 10e9 /L
* International normalization ratio (INR) greater than 1.6
* Total bilirubin greater than 1.5 x ULRR
* ALT or AST greater than 2.5 x ULRR if no demonstrable liver metastases or greater than 5.0 x ULRR in presence of liver metastases
* History of bleeding diathesis (ie, disseminated intravascular coagulation \[DIC\], clotting factor deficiency)
* History of long-term anticoagulant therapy (other than antiplatelet therapy)
* History of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or Mannitol)
Adaption and Testing of the Quality of Life in Short Stature Youth (QoLISSY) Questionnaire for Parents With Children From 0-4

The aim of the study is the adaption, implementation and validation of the instrument for the investigation of the short stature specific quality of life (QoLISSY) for children (age 0-4 years) with achondroplasia (ACH), Small for Gestational Age (SGA) and Growth Hormone Deficiency (GHD) from a parental perspective.

The questionnaire is intended to be particularly applicable in clinical trials, with a focus on the impact of short stature and the physical functionality of those affected. The instrument will be further developed according to the "Guidelines for PRO instrument development". It should be practical in its application and interpretation and applicable in the international context.

In addition, it will be investigated whether, from the parents' point of view, other instruments are suitable for measuring the quality of life of their short statured children. Their preference regarding the instruments will be assessed so that a recommendation can be made as to which instruments are particularly suitable.

A systematic literature review will be conducted to identify suitable instruments to measure the quality of life of short statured children aged 0 to 4.

Approximately 10-20 parents of 0-4 year old children with ACH, GHD and SGA will be recruited for the qualitative data collection (n = 30 to 60). The patients will be recruited through the BKMF (German Association for People of Short Stature and their Families).

In order to test the psychometric properties of the instruments, approximately 30 parents (15 mothers / 15 fathers) of 0-4 year old children with ACH, GHD and SGA will be recruited for the quantitative part of the study (n = 90). All participants will be asked to complete the QoLISSY or other instruments found suitable in the pilot test. For the purpose of cross-validation, the PEDSQL will be used in parallel.

Two weeks after receiving the field test, the re-test will be sent to ensure the reliability of the study. The re-test will be administered to a minimum of 20% of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children aged 0-4 with the diagnosis Achondroplaisa, Short for Gestational Age or Growth Hormone Defiency

Exclusion Criteria:

* Other diagnosis than Achondroplaisa, Short for Gestational Age or Growth Hormone Defiency
* Children older than 4 years of age
Safety Study of Nifurtimox for Relapsed or Refractory Neuroblastoma

There is currently no curative treatment for children with relapsed/refractory neuroblastoma, and for these children the 5 year survival rate is \<10%. As such, new therapeutic approaches are needed to treat these children. This Phase 1 clinical trial is specifically designed to test the safety and toxicity of nifurtimox when given in combination with cyclophosphamide and topotecan for the treatment of relapsed and/or refractory neuroblastoma . Prior to study opening, 3 pediatric patients with neuroblastoma have received nifurtimox in combination with this chemotherapy regimen, and all have had significant measurable responses without undue toxicity. These case reports, as well as our in vitro and in vivo investigations into the biologic effect of nifurtimox on neuroblastoma cells has prompted the development of this Phase I study. This Phase I study will involve a dose escalation trial of daily oral nifurtimox alone for one 21 day cycle of therapy, followed by continuation of nifurtimox with the addition of standard doses of cyclophosphamide (5 days) and topotecan (5 days) for 3 additional 21 day cycles. Our primary aim is to evaluate the safety of nifurtimox alone and in combination with these chemotherapy agents in multiply relapsed/refractory patients. Our secondary aim will be to evaluate the pharmacokinetics of nifurtimox as well as treatment response.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 0-21 years at the time of study entry.
2. Diagnosis: Histologic verification of neuroblastoma at original diagnosis or relapse.
3. Disease Status: Refractory or first or multiple relapsed neuroblastoma with measurable disease by radiographic scan (CT or MRI and MIBG), abnormal urinary catecholamine levels, or positive bone marrow biopsy/aspirate. MIBG not required if subject's neuroblastoma is previously determined to not uptake MIBG isotope (not MIBG avid).
4. Current disease state must be one for which there is currently no known curative therapy.
5. A negative urine pregnancy test is required for female participants of child bearing potential (\>13 years of age).
6. Patients must have adequate liver function as defined by AST or ALT \<10x normal and a bilirubin \<1.5mg/dl
7. Informed Consent: All patients and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines

Exclusion Criteria:

1. Life expectancy \<3 months
2. Investigational Drugs: Patients who are currently receiving another investigational drug.
3. Anti-cancer Agents: Patients who are currently receiving other anticancer agents.
4. Infection: Patients who have an uncontrolled infection.
5. Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
6. Patients may not receive bisphosphonates (i.e. Zometa) within 7 days of start of therapy.
Alterations in Gait, Strength, and Power After Ruck Marching

The purpose of this study is to determine change in injury risk and performance variables in males and females after walking unloaded and carrying a load with two different distributions (high-pack placement and mid-pack placement) to identify differences in injury risk


Eligibility Criteria:
Inclusion Criteria:

* Healthy, physically active individuals
* 18-39 years old

Exclusion Criteria:

* History of musculoskeletal injury within the last six months or still under a physicians care for an injury occurring more than six month prior
* History of spinal disc injury
* History of cardiovascular, metabolic, respiratory, neural, or renal disease
* No previous history or education of completing resistance exercise
* Hypertensive or tachycardic during the screening visit (SBP \> 139 mmHg, DBP \> 89 mmHg, heart rate \> 100 bpm)
* Taking medication or supplements with a known side effect of affecting physiologic responses to exercise (e.g., beta blockers, omega-3 fatty acids, statins, aspirin)
* Any form of tobacco or nicotine use
* A positive pregnancy test at any point in the study
* Study physician discretion based on any other medical condition or medication
* Gastrointestinal disease or previous surgery prohibiting internal body temperature pill use. Subjects who have any contraindication to internal body temperature pill ingestion will be given the option to insert the pill rectally (as a suppository) or use a rectal probe.