cyrilzakka/clinical-trials huggingface dataset:
Early Detection of At-risk Septic Patients

The purpose of this study is to determine whether additional investigations used in other parts of healthcare can be used in the Emergency Department to identify critically ill patients quicker than usual care.

The investigators intend to recruit 56 patients with suspected sepsis who attend the Emergency Department. The investigators want to use a device to monitor tissue oxygen levels when they first come into the Emergency Department as well as the change in tissue oxygen levels when a tourniquet is applied for 3 minutes. The investigators will take novel blood tests when the patient is having their routine bloods. Finally, the investigators will use a special camera to take specialised pictures of the small blood vessels under the tongue which will show blood flow through these vessels. The investigators will follow the recruited patients and determine if our extra data is better at determining who needs critical care. A significant proportion of patients may be too unwell or too distressed to consent to be part of this study. At the earliest opportunity, the investigators will ask patients when they have been stabilised and are able to give consent. If they say no, they will be removed from the study and their care will not be affected by this decision.

The results could help us identify septic shock as early as possible so that these unwell patients are identified early and get the correct treatment they need. This could mean starting advanced treatments usually found in the Intensive Care Unit very early on in a patient's journey.

Eligibility Criteria:
Inclusion Criteria:

1. Differential diagnosis which includes infection
2. Change in the quick Sequential Organ Failure Assessment (qSOFA) ≥2 or National Early Warning Score 2 (NEWS2) score ≥5
3. Aged ≥18 years

Exclusion Criteria:

1. Traumatic injury
2. Rockwood frailty score ≥6
3. Critical care therapy previously believed to not be in patient's best interests
4. Critical care therapies-initiated pre-hospital. Critical care therapies defined as:

   4.1 Mechanical ventilation 4.2 Vasopressor/inotrope therapy 4.3 Sedation or a general anaesthetic 4.4 Pre-hospital transfusion of blood products 4.5 Extra-corporeal support
5. Advanced directive refusing critical care therapies.
6. Acute cardiac failure
7. Active gastrointestinal bleed
8. Massive pulmonary embolism
9. ICU admission declined by critical care team
10. Treated in an acute hospital \<6 hours before presentation to the Emergency Department
Weight Loss Surgery in Adolescents With Extreme Obesity

The use of bariatric surgery in adolescents is controversial. On one side, bariatric surgery is the only effective treatment to achieve sustained weight loss in adults with extreme obesity. Comorbidities are reversed and mortality is reduced. In adolescents, bariatric surgery is equally effective; however, due to the paucity of long-term data, the long-term effects and risks are unknown. Thus, due to surgical risk and ethical implications, bariatric surgery is considered experimental in Germany. Nevertheless, case volumes are increasing.

The aim of this study is to evaluate the benefits and risks of adolescent bariatric surgery in the context of a structured preparation and follow-up program. The study is a subproject of the study "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care" (DRKS00004172). At 5 German university centers (Ulm, Datteln, Berlin, Essen, Leipzig), youth who undergo bariatric surgery and are participants in the overall project will be enrolled in a structured preparation and follow-up program. The program is designed to improve adherence and compliance and will result in comprehensive follow-up data. In addition to the data gathered in the overall project, subjects participating in subproject 3 will undergo assessments pertinent to bariatric surgery, as proposed in the American Teen-LABS study (http://www.cincinnatichildrens.org/ research/divisions/t/teen-labs/default/). Comparison will be made with BMI matched adolescents who participate in the overall project but do not undergo bariatric surgery.

In November 2014 recruitment for the overall project was completed. However, patients interested in bariatric surgery will still be recruited until September 2016. There assessment will be the same as for patients recruited earlier. However, in an amendment in December 2014, the frequency of assessment via questionnaire was reduced from biannually to annually. In addition, a travel reimbursement of 30€ for each study visit was implemented.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 35 kg/m2 with severe comorbidity or BMI ≥ 40 kg/m2 with relevant comorbidity
* completed longitudinal growth
* stable social surroundings
* exhaustion of conservative treatment
* participation in the project "Adolescents with extreme Obesity"
* adequate compliance and adherence

Exclusion Criteria:

* treatable causative condition
* unstable medical, psychosocial or psychiatric comorbidity
* alcohol or drug abuse
* pregnancy
* contraindication for bariatric surgery
An Open-label Study for Non-responders of VRDN-001-101 and VRDN-001-301 (OLE)

An open-label study for participants who received VRDN-001 or placebo and were non-responders at end of the treatment period assessment (i.e., 15 weeks) in the VRDN-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies


Eligibility Criteria:
Key Inclusion Criteria:

1. Be able to understand the study procedures and the risks involved and be willing to provide written informed consent before the first study-related activity
2. Have completed at least 5 IV infusions and assessments required to determine proptosis responder status 3 weeks post the fifth IV infusion (i.e., Week 15) as defined in either the VRDN-001-101 or VRDN-001-301 pivotal studies
3. Been a participant in either the VRDN-001-101 or VRDN-001-301 studies and found to be a non-responder as defined within the VRDN-001-101 or VRDN-001-301 study
4. Not require immediate surgical ophthalmological or orbital surgery in the study eye for any reason
5. Must agree to use highly effective contraception as specified in the protocol

   ⦁ Female TED participants must have a negative urine pregnancy test at screening
6. Be willing and able to comply with all the requirements of the protocol for the entire duration of the study

Key Exclusion Criteria:

Participants must not:

1. Have received prior treatment with another anti-IGF-1R agent
2. Have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose
3. Have received other immunosuppressive drugs or another investigational agent for any condition, including TED (other than VRDN-001 or placebo associated with the VRDN-001-101 or VRDN-001-301 pivotal studies), or any other therapy for TED, within 8 weeks prior to first dose
4. Have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
5. Have had previous orbital irradiation or decompression surgery involving excision of fat for TED to the study eye's orbit
6. Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor
A 52 Week Open Label Extension Trial Following the Recurrence Prevention Study R076477-SCH-301 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.

The purpose of the study was an Open Label Extension to the recurrence prevention study to evaluate long-term safety and tolerability of paliperidone ER in subjects with schizophrenia.

The primary objective of the open-label extension was the long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia. In addition, the long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, as well as quality of life, health economics, and subjective sleep measures, was explored. This open-label extension study followed a recurrence prevention study (R076477-SCH-301) that had both an open-label run-in/stabilization phase and a double-blind, placebo-controlled phase.

Open-label study drug (ER OROS paliperidone 3 mg to 15 mg/day) was administered for 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who had experienced a recurrence event during the double blind phase of Study R076477-SCH-301
* Remained recurrence free until the end of the double-blind phase, or were in the run-in or stabilization phases when the study was terminated
* Who signed the informed consent for the open-label extension
* And who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open-label extension

Exclusion Criteria:

* Not eligible to enter the open-label phase if believed to be at significant risk for suicidal or violent behavior during the open-label extension trial
* Were pregnant or had received an injection of a depot antipsychotic since entry into the preceding double-blind phase
Genetic Disorders of Obesity Program Database

This study collects data on children with severe, early-onset obesity.

Children and adolescents who have suffered from severe weight gain prior to 5 years of age and who are seen in the Genetic Disorders of Obesity Program at Texas Children are asked to participate in a prospective, observational study. The investigators collect demographic information, body measurements, medical/family history, as well as other questionnaires. Additionally, genetic information, medical lab results, and responses to treatment options are collected. The goal of the study is to determine if the investigators can better understand which children would benefit from testing and further workup as well as to understand how obesity develops in these children and adolescents.

Eligibility Criteria:
Inclusion Criteria:

* For individuals 2 years and older, BMI \> 97 percentile
* For individuals \< 2 years old, weight-to-length ratio \> 95th percentile

Exclusion Criteria:

* No other exclusion criteria
Starch or Saline After Cardiac Surgery

When people undergo major surgery, they require intravenous supplementation of fluids for a number of reasons:

* to compensate for no oral intake
* to support blood pressure and organ function during and after surgery
* to replace lost fluid or blood volume

There are a variety of fluid choices doctors have to provide to patients, and it is still not definitively known whether some fluids are better than others in specific situations. This is a particularly interesting question in patients undergoing heart surgery because of the significant volume of fluids used over the entire course of hospitalization, including before the operation, during the operation, and after the operation.

There has been some scientific evidence that the use of starch-based fluids (synthetic colloids) leads to better oxygen delivery to the organs with a smaller volume of fluid given, providing for better recovery from surgery. However, there has also been some scientific evidence that the use of these fluids can harm kidney function. Importantly, none of these large-scale studies were carried out specifically in patients undergoing heart surgery.

The purpose of this study is to answer the question of whether the use of starch-based fluid in the heart surgery patient makes for a safer and faster recovery, causes kidney dysfunction, or makes no discernable difference.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective primary isolated on-pump coronary artery bypass grafting

Exclusion Criteria:

* pregnant patients
* patients with an active intra-cranial bleed
* patients with a history of hypersensitivity to starch solutions
* patients with Stage 4 or 5 Kidney Disease (estimated glomerular filtration rate \< 30 ml / min / 1.73 m2)
* patients with a significant preoperative metabolic acidosis, defined by a preoperative capillary blood pH less than or equal to 7.2 and a serum bicarbonate less than 15
Development of Fluid Intake App for Management of Fluid Intake During Hemodialysis

Methods are needed to help decrease interdialytic weight gains in hemodialysis patients. One potential method for accomplishing this goal is to develop an app for smartphones that allow patients to track their fluid intake throughout the course of the day. This protocol is designed to test the safety and efficacy of this app, followed by use of the app in patients with large fluid weight gains between HD sessions. In the Vanguard phase, patients without large interdialytic fluid gains (less than 4%) will use the app to to determine the association between the interdialytic weight gain and the fluid consumed as recorded by use of the app for each interdialytic period. The app will be modified, if needed, prior to initiation of the full scale trial.

For the Vanguard phase of the trial, a survey will be used to assess the usability of the app as well as to collect recommendations for changes to the app itself (appendix one). For this Vanguard phase study, the survey for participants will be designed to assess the usability of the app (ease of use in general, ease of capturing fluid intake data, including the choice of preselected volumes for fluid containers, reasons for not using the app more frequently, the usefulness of the app notifications, ease of sending data to the study coordinator for review). The survey for the study coordinator will be designed to assess the ease of reviewing data from participants and the perceived difficulty of patient use of the app.

Eligibility Criteria:
Inclusion Criteria:

* Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study.
* Adult chronic hemodialysis patients who are at least 18 years of age
* Average interdialytic fluid gains of less than 4% of body weight for both weekdays and weekends for a 30 day period
* Access to a smartphone for use of the app and comfort with using apps on a regular basis
* Access to a smartphone running under either iOS or Android operating systems
* Sufficient knowledge and understanding of the English language to use the application available only in English (US) language
* Mental capacity to use and understand the fluid management app
* Willingness to share intake data collected with the research team

Exclusion Criteria:

* Scheduled for a living related renal transplant in the next four months
* Class III or IV heart failure
* Need for chronic oxygen therapy due to pulmonary disease
* Hospitalization within 30 days of entry into the study
* Current participation in a randomized clinical trial or in the exclusion period of another clinical trial
Studies in Porphyria III: Heme and Tin Mesoporphyrin in Acute Porphyrias

OBJECTIVES: I. Compare the efficacy of heme arginate, singly or in combination with tin mesoporphyrin, in lowering porphyrin precursors in patients with asymptomatic acute intermittent porphyria.

II. Evaluate and compare the safety and tolerability of these treatment regimens in this patient population.

PROTOCOL OUTLINE: This is an unblinded, dose ranging study. Patients receive heme arginate alone or in combination with tin mesoporphyrin.

Patients receive tin mesoporphyrin IV as a single dose. Heme arginate is administered as a single intravenous infusion.

Patients are entered in cohorts of 4. Subsequent cohorts of 4 patients each receive escalating doses of tin mesoporphyrin in combination with 1 of 2 different dosages of heme arginate. Subjects must maintain a constant diet.

Patients experiencing adverse reactions are followed as clinically indicated.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Documented acute intermittent porphyria in remission for at least 1 month
* Increased excretion of porphyrin precursors
* Absence of neurovisceral symptoms due to porphyria for at least 1 month

--Prior/Concurrent Therapy--

* At least 1 month since prior heme preparation therapy
* Concurrent medication for coexisting condition is allowed, as long as dose and pattern of administration is held constant during study

--Patient Characteristics--

* Renal: Urinary porphobilinogen excretion of at least 20 mg every 24 hours
* Other: Not pregnant Fertile female patients must use effective contraception during and at least 6 months before study At least 1 month since any symptoms of disease No concurrent acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage No known hypersensitivity to heme arginate, tin mesoporphyrin, another heme preparation, or related heme analogue No other condition that may increase risk to patient
Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.

The main objective of this study is to confirm the effectiveness and safety profile of NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea).

Additionally we also investigate the differences of effectiveness of NPC-01 in comparison with IKH-01 in the treatment of secondary dysmenorrhea as a reference, because IKH-01 is already marketed at them.

To achieve these, closed testing procedure is used in this study. After confirming statistical differences between NPC-01 and Placebo in the total dysmenorrhea, stratified analysis is carried out for primary dysmenorrhea (NPC-01, Placebo), and secondary dysmenorrhea (NPC-01, IKH-01 and Placebo).

Eligibility Criteria:
Inclusion Criteria:

* dysmenorrhea

Exclusion Criteria:

* severe hepatopathy
* pregnant woman
Creatine-Guanidinoacetic Acid Supplementation for Sarcopenia (CREGAAS)

Sarcopenia-driven brain and muscle creatine deficit could be seen as a distinctive pathological facet of this condition, and this might be approached with targeted therapies in aim to restore creatine homeostasis in target tissues. Among potential therapeutic candidates, guanidinoacetate (GAA) appears recently as a direct precursor of creatine that may favorably upregulate muscle and brain creatine concentration. Interestingly, GAA-creatine mixture was found to be superior than creatine itself to effectively improves bioenergetics in the human brain and muscle in healthy humans, perhaps due to the unique transportability features of this combination. Here, we plan to evaluate does creatine-GAA supplementation affects various biomarkers of sarcopenia in elderly.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 70 years
* Free of acute disorders

Exclusion Criteria:

* History of dietary supplement use during the past 4 weeks
Manipulative Therapy Techniques to Treat Chronic Low Back Pain

The purpose of this study is to analyze the effectiveness of a three manipulative therapy techniques in People with Chronic Low Back Pain.

Objective: To analyze the effectiveness of a three manipulative therapy techniques in individuals with chronic non-specific low back pain of mechanical etiology.

Design: Randomized clinical trial. Setting: Almeria, South Spain. Participants: Sixty two with chronic non-specific low back pain will be randomly assigned to an experimental or control group.

Intervention: For 3-week, the experimental group will undergo treatment comprising 3 sessions (1/week) of manipulative therapy techniques in the lumbar and sacral areas, and the control group will receive a functional technique in the lumbar area.

Main Outcome Measures: Oswestry disability index, pain visual analogue scale, Tampa scale for kinesiophobia, Roland-Morris disability questionnaire, McQuade test, quality of life scores and the range of trunk anteflexion motion, which were all assessed before the treatment and immediately after the last treatment session.

The primary outcome measure is the change in the RMDQ score at the end of the 3 weeks study period. A difference of 2.5 point is considered to be the minimum clinically important difference in the RMDQ score. A sample size of 62 patients (31 per group) would enable detection of a 2.5 point difference between groups given 80-90% power, a 5% (two-tailed) significance level, and a conservative standard derivation of 5 points. Key baseline demographic variables and clinical measure scores will be compared between groups by using independent Student t tests for continuous data and chi-square tests for categorical data. Separate 2x2 mixed model ANOVA with repeated measurements for the time factor need to be conducted in order to test between-groups differences in visual analogue scale, McQuade test, range of trunk anteflexion motion, Oswestry disability index, Roland Morris disability questionnaire, Tampa scale for kinesiophobia, and quality of life as the dependent variables, with group (functional technique or three manipulative therapy techniques) as the between subjects variable and time (baseline, post-treatment). A paired t-test will perform to test within-group differences in score changes from pre- to post-treatment. Effect size will test using Cohen's d. p = 0.05 will be considered significant in all tests.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain for ≥ 3 months.
* Score ≥4 on the Roland Morris disability questionnaire.
* No undergoing another physical therapy treatment.
* Inability to achieve lumbar muscle flexion-relaxation in trunk flexion

Exclusion Criteria:

* Clinical signs of radiculopathy.
* Presence of lumbar stenosis.
* Fibromyalgia.
* Spondylolisthesis.
* History of spinal surgery.
* Treatment with corticosteroids in the past two weeks.
* Disease of the central or peripheral nervous system.