cyrilzakka/clinical-trials huggingface dataset:
Insulin and Insulin Pulses During Fasting

Fasting hyperglycemia contributes disproportionately to nonenzymatic glycosylation and the microvascular complications of type 2 diabetes. However, little is known about the regulation of glucose concentrations in the fasting state relative to what is known about the postprandial state. The proposed experiment is part of a series of experiments designed to establish how glucagon and insulin interact with their receptors to control fasting glucose in health and in prediabetes.

Decreased insulin action increases glucagon concentrations. In rodents, insulin signaling restrains glucagon secretion. It is unclear if this is the case in all (subtypes of) prediabetes. Impaired hepatic insulin action exacerbates glucagon's effects on endogenous glucose production. Also, insulin resistance in the β-cell impairs negative feedback inhibition of insulin secretion. This leads to hyperinsulinemia in rodents and humans. How these variables interact is unknown. This experiment will determine how insulin variably regulates fasting glucagon (and insulin) secretion directly, or indirectly, in prediabetes.

The inability of the proinsulin to insulin ratio to reliably predict β-cell integrity, endoplasmic reticulum stress and β-cell function has led to the identification of novel markers of β-cell health. In addition, the relationship of glucagon and insulin pulses will be quantified. Preliminary data shows that there is heterogeneity in these relationships even in normal fasting glucose. Th experiment will also determine how islet hormone / glucose crosstalk and pulse characteristics contribute to prediabetes.

Eligibility Criteria:
Inclusion Criteria:

* people with normal or impaired fasting glucose and normal or impaired glucose tolerance

Exclusion Criteria:

1. HbA1c \> 6.5%
2. BMI ≥ 35 Kg/M2
3. Use of any glucose-lowering agents including metformin or sulfonylureas.
4. For female subjects: positive pregnancy test at the time of enrollment or study
5. History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
6. Active systemic illness or malignancy.
7. Symptomatic macrovascular or microvascular disease.
8. Hematocrit \< 35%
Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery

The provision of adequate pain relief following major liver surgery is essential, not only for patient comfort, but for the prevention of complications, such as chest infection.

Commonly, pain relief in the first few days after surgery is provided by epidural analgesia. Drugs are delivered to the area around the spinal cord, through a fine plastic tube placed in the patients back, and this blocks sensation from the abdomen downwards, thereby providing effective pain relief without the need for opiate analgesia (e.g. morphine). Opiate analgesia can cause nausea, drowsiness and constipation, and its use should be minimised. Epidurals, however, can be associated with some problematic side effects. Low blood pressure is commonly encountered, and not only can its treatment be associated with complications, but patients are often confined to bed.

Mobility can also be limited if muscle function in the legs, (in addition to sensation), is inadvertently affected by the epidural drugs. Other problems associated with epidural use are the relatively common failure of the technique to provide adequate analgesia (20%), and some extremely rare but potentially disastrous complications of epidural insertion.

An alternative technique, is the provision of pain relief directly into the wound, via one or more multi-holed tubes(catheters), placed either in or close to the wound. This technique alone does not provide as effective analgesia as a functioning epidural, but when combined with other intravenous or oral analgesia, has been shown to be effective following a variety of surgical procedures.

It is hypothesised that, following major liver surgery, the use of this latter technique may result in superior outcome and faster recovery, when compared with epidural, by avoidance of the side effects and complications discussed above.

In this study, patients scheduled to undergo major liver surgery at the Royal Infirmary of Edinburgh with be randomly assigned to receive the first two days of pain relief either by epidural, or by wound catheter plus additional analgesia. Both groups will then receive an identical oral analgesic regime for the remainder of the hospital stay.

Outcomes of interest will include the quality of pain relief attained, patient mobility, frequency of complications, and overall recovery time.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing open hepatic resection for benign or malignant conditions.
* Able to understand the nature of the study and what will be required of them.
* Men and non-pregnant, non-lactating women.
* BMI 18-40.

Exclusion Criteria:

* Patients with contraindication to either epidural or wound catheter techniques.
* Inability to give written, informed consent.
* Patients with dementia or neurological impairment.
* Patients with pre-existing condition limiting mobility.
* Underlying cirrhotic liver disease.
* Jaundice (Bilirubin \> 50 μmol/L).
* Liver resection combined with secondary surgical procedure.
Biomarkers in Pain and Pain Treatment

The goal of this research project is to explore if levels of inflammation predict levels of comorbid mood disorders and treatment success in chronic pain patients. More knowledge in this respect will advance our understanding of chronic pain and comorbid syndromes, and facilitate subgroupings of patients based on the presence and/or level of low-grade inflammation. This research is an important step towards finding an explanation to why treatment effects following behavioral interventions differ across individuals, and generate new hypothesis regarding novel treatment approaches. The specific aims are: 1) to explore if baseline levels of inflammatory biomarkers predict the effects of behavioral intervention and 2) to investigate if baseline levels of inflammatory biomarkers are associated with psychological co-morbidity (e.g. depression, anxiety and fatigue) in patients with chronic pain.


Eligibility Criteria:
Inclusion Criteria:

1. Referred to a specialist clinic within pain management
2. Equal to or older than 18 years
3. Chronic pain (\> 6 months)
4. The pain is refractory
5. The pain results in significant functional limitations
6. Stable medication in the last 2 months and no planned changes in medication (except possibly discontinuation or lowering of current dose)

Exclusion Criteria:

1. Spontaneous improvement can be expected (without treatment)
2. Psychiatric comorbidity a) is deemed to be the main reason for the restrictions, or b) should be promptly evaluated and possibly treated, or c) may adversely affect the treatment given in the context of the study
3. Significant risk of suicide
4. Poor teamwork, defined as repeated missed appointments during the assessment / investigation phase
5. Language difficulties (Swedish)
Evaluation of Remote DBS Programming.

Deep brain stimulation (DBS) represents the treatment of choice for advanced stages of Parkinson's disease (PD). Currently, adaptive closed-loop stimulation systems that apply disease-specific biomarkers, such as local field potentials (LFPs), are being actively examined to facilitate DBS programming. However, the most suitable feedback signal, still remains to be determined. The investigators previously tested the usefulness of the patient's subjective rating on a visual analogue scale (VAS) as a potential feedback signal for DBS adjustment and found that VAS-based programming lead to similar results as our standard approach. One of the practical advantages of using VAS-based programming strategies - in addition to saving time - is the principal applicability of such an approach to a remote programming setting, although a validation of such an approach is required. Within the scope of a prospective, randomized multicenter clinical trial (the REMOTE Trial), the investigators will examine the effectiveness and safety of VAS-based remote DBS programming in PD by using a novel and recently introduced software platform (Abbott NeurosphereTM Virtual Clinic) that allows for the programming through a smartphone-based video connection with the patient. Therefore, n = 50 PD patients undergoing STN-DBS surgery will be randomized and subsequent to surgery will have their IPG settings adjusted either during regular visits at the hospital or alternatively be programmed remotely through a VAS-based approach. Prior to surgery and after a 90 days follow-up period, we will assess specific clinical (MDS-Unified Parkinson's Disease Rating Scale = UPDRS, Parkinson's Disease Questionnaire-39 sum index = PDQ-39 SI, Beck Depression Inventory = BDI, Montreal Cognitive Assessment Scale = MOCA) parameters to determine the effectivity and safety of the two different strategies on the patient outcome and to correlate it with VAS ratings and MRI data. The results will support the examination of remote-based DBS programming and evaluate the patient's subjective judgment as a valid feedback signal.


Eligibility Criteria:
Inclusion Criteria:

* Age between 35 and 80 yrs.
* Ability to communicate with the study physician and to understand the requirements of the study
* Idiopathic Parkinson's Syndrome; IPS (according to MDS-Criteria)
* Implantation of a DBS device for the stimulation of the subthalamic nucleus (STN) to treat PD.

Exclusion Criteria:

* Any inability to communicate with the study physician and to understand the requirements of the study
* Exclusion criteria of an idiopathic Parkinson's syndrome (IPS)
* Fulfills the criteria of dementia (according to the International Classification of Diseases (ICD) 10)
Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes

Canakinumab is a fully human anti-interleukin-1β (anti-IL-1β) monoclonal antibody (IgG-1 class). Canakinumab is designed to bind to human IL-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine.

The study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous injections of 2.0 mg/kg Canakinumab, or placebo for 12 months. All groups will receive standard intensive diabetes treatment with insulin and dietary management.

Participants randomly assigned to Canakinumab treatment or placebo will receive a total of 12 injections over one year.

All subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up until study end. Enrollment is expected to occur over two years.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 6-45 years
* Be within 3-months (100 days) of diagnosis of type 1 diabetes
* Must have at least one diabetes-related autoantibody present
* Must have stimulated C-peptide levels \>0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization
* If participant is female with reproductive potential, she must be willing to avoid pregnancy and have a negative pregnancy test during the 12 months of treatment and for an additional 3 months after completing treatment
* Be at least one month from time of last live immunization received
* Willing to forgo live vaccinations for 24 months
* Must be willing to comply with intensive diabetes management
* Must weigh at least 20 kg (44 lbs) at study entry

Exclusion Criteria:

* Are immunodeficient or have clinically significant chronic lymphopenia (low white blood cell count)
* Have an active infection
* Have a positive PPD test result
* Be currently pregnant or lactating, or anticipate getting pregnant
* Ongoing use of medications known to influence glucose tolerance
* Require use of other immunosuppressive agents
* Have serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C infection
* Have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies
* Be currently participating in another type 1 diabetes treatment study
Private-sector Access to Testing for Health Sustainability

New and innovative strategies are urgently needed to increase the uptake of HIV prevention and sexual and reproductive health services among adolescent girls and young women (AGYW) in sub-Saharan Africa. To ensure the real-world sustainability of free distribution of HIV self-test kits to AGYW by private drug shops and pharmacies, investigators will rigorously test supply-side subsidy structures for shopkeepers' provision of HIV-self test kits to AGYW combined with prosocial motivational supports. The combination of non-monetary and monetary support structures aims to emulate real-world health financing models for public-private partnerships and ultimately aims to improve equity in access to critical prevention services for AGYW at scale.

This is an implementation-effectiveness trial that tests program adoption, implementation, and maintenance of free HIV self-test kit (HIVST) distribution to adolescent girls and young women (AGYW) financed by profits from HIVST kit sales to non-AGYW customers. To initiate adoption, the study will offer pharmacy and drug shopkeepers the opportunity to procure subsidized HIVST to simultaneously distribute to AGYW for free (reimbursed by the study mimicking government-supported provision) and sell to non-AGYW customers for profit, gradually phasing out procurement subsidies over 36 months to test maintenance of the segmented pricing model for real-world sustainability (Aim 1). Investigators will implement non-monetary motivation boosters to sustain shopkeeper engagement over the study period and use mixed-methods to understand shopkeepers' experiences and necessary conditions for program maintenance and provider behavior change (Aim 2), which will inform the co-design of a progressive scale-up plan to achieve national coverage with Tanzanian AGYW, public, and private partnership stakeholders (Aim 3). At the study's conclusion, investigators will have a comprehensive understanding of the support structures shops need to sustain HIVST kit provision for AGYW. Importantly, the study will contribute to generalizable learning about the structures required for commercially sustainable public-private partnerships for high-impact public health interventions.

Eligibility Criteria:
Inclusion Criteria:

* Owners/staff of retail drug shops and pharmacies located in the study regions
* Age 18 and older

Exclusion Criteria:

* Refusal to install and track sales and distribution of HIVST kits using the Maisha Meds data system provided.
The Effect of High vs. Low Fluid Volume on Ocular Parameters in Prone Spine Surgery

The purpose of this trial is to compare the effect of different fluid volume infusion on ocular parameters in patients undergoing spine surgery in prone position.

In the prone position, the intraocular pressure and optic nerve sheath diameter increase progressively with time as compared with those in the supine position. Excessive fluid infusion may further increase intraocular pressure and optic nerve sheath diameter. Pulse pressure variation (PPV) is a dynamic index which can effectively assess fluid responsiveness during general anesthesia.Therefore,the investigators have designed a study to compare the effect of different fluid volume infusion guided by low and high PPV indices on intraocular pressure and optic nerve sheath of patients undergoing prone spine surgery with general anesthesia. One group of the patients will receive relatively loose fluid infusion (target value of PPV: 6%-9%),while the other group of the patients will receive limited fluid infusion (target value of PPV: 13%-16%).

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective spine surgery in prone position under general anesthesia
* American Society of Anesthesiologists (ASA) physical status I or II
* Have signed consent form

Exclusion Criteria:

* History of eye disease or eye surgery
* Pregnancy or breast feeding
* Known Allergy to latex or Ringer's lactate solution
* Hyperlactacidemia，uncontrolled hypertension, diabetes mellitus, arrhythmia, cardiovascular disease，chronic pulmonary disease, swelling of any body part, abnormal of liver or renal function, anemia, etc.
* Body mass index（BMI）\>30
* Expected operation time \>6 hours
* Estimated Intraoperative hemorrhage \>1000ml
* Taking part in other clinical trials in the last 3 months or at present
An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris

The primary objective of this study is to determine the long-term safety of CB-03-01 cream, 1% applied twice daily for an additional nine months in study participants with acne vulgaris that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.

This was a multicenter, open label, long-term extension study for CB-03-01 cream, 1% focused on safety in male and female participants, 9 years or older who completed one of the Phase 3 pivotal studies \[CB-03-01/25 and CB-03-01/26\]. Participants applies the active medication (CB-03-01 cream, 1%) twice daily to the entire face and, if designated by investigator AND desired by the participant, truncal acne for nine additional months of treatment. Thus, overall participants were exposed to CB-03-01 cream, 1% for a total treatment of up to 12 months (0 or 3 months in the Phase 3 pivotal study and an additional nine months in this long-term safety study).

Participants treated facial acne per protocol for nine months. Treatment of truncal acne was discussed by the investigator and participant. Treatment on the face and/or trunk was discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area (i.e., face and trunk).

Participants were rolled over from the Phase 3 pivotal studies \[CB-03-01/25 and CB-03-01/26\] into this long-term, safety study in order to achieve at least 300 participants on-study at 6 months and 100 participants on-study at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Participant has successfully completed participation in one of the Phase 3 pivotal studies \[CB-03-01/25 and CB-03-01/26\].
* Participant agrees to use effective method of contraception throughout study, if applicable.
* Participant has provided written informed consent or assent.
* Participant is willing to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

* Participant is pregnant, lactating, or is planning to become pregnant during the study.
* Participant has any skin disease or condition that could interfere with the safety evaluation of the test products or requires the use of interfering topical or systemic therapy.
* Participant has any condition which, in the investigator's opinion, would make it unsafe or unsuitable for the participant to participate in this research study.
* Participant plans to use any other investigational drug or device during participation in this study.
* Participant has known hypersensitivity or previous allergic reaction to the drug or any of its ingredients.
* Participant is or plans to use any restricted systemic and/or topical anti-acne preparations or medications during the study
Clinical Assessment of Spinal Muscular Atrophy Type II and III (SMA Europe)

The aim of this project is to establish a network of clinical teams including the major neuromuscular centers in Europe.

We plan to work together to find the best common outcome measures for the following multicenter therapeutic trials.

16 patients (6 ambulant and 10 non ambulant), affected by type II and type III SMA will be enrolled and assessed at baseline and 6 and 12 months later. Non ambulant patients will be assessed using the modified version of the Hammersmith Motor Functional Scale while ambulant patients will be assessed using the extended module of the Hammersmith Motor Functional Scale and timed items, the 6 minute walk and a step activity monitor. All patients will also be assessed using the Motor Function Measure (MFM), that covers the whole range of activities for both ambulant and non ambulant patients. All measures will undergo a process of validation including inter observer reliability. This information will be most valuable for any future trial and will make the groups involved ready to participate to future collaborative studies saving a lot of time on the preliminary aspects (validation, reliability, training) that will be fulfilled by the present study. The study will also provide natural history data for a 12 month period on patients with SMA II and III.

Eligibility Criteria:
Inclusion Criteria for ambulant patients:

* age between 30 months and 24 years
* documented SMA diagnosis by genetic tests; Each should also have the determination of the SMN2 copy number
* able to walk 10 meters without support
* subject who signed an informed consent- subject affiliated to a social security system

Inclusion Criteria non ambulant patients:

* documented diagnosis of SMA by genetic tests
* not able to walk 10 meters without support
* subject affiliated to a social security system
* subject who signed an informed consent

Exclusion Criteria:

* Patient who are currently involved in other clinical trials
* severe intellectual impairment limiting the comprehension of the demanded tasks
* acute neurologic, inflammatory, infectious, endocrine, orthopedic disease in the month preceding the inclusion
* chronic neurologic (besides SMA), inflammatory, infectious, endocrine, orthopedic disease which are not a natural consequence of SMA
* spinal surgery scheduled 6 months before or within 12 months after enrollment
* pregnant women
Internet-based Cognitive Behavioral Therapy for Individuals With Gambling Disorder in Indonesia

Gambling disorder (GD) has become a wide concern in Indonesia, as many negative consequences aroused from this psychiatric condition. Prompt treatment with appropriate method of delivery is required to achieve optimal outcome in GD patients. This study aims to determine the effectiveness and feasibility of internet-based cognitive behavioral therapy (iCBT) in treating GD.

This non-randomised pilot and feasibility study will recruit 20 people with GD. All participants will receive the iCBT intervention through self-learning videos and guided weekly group sessions. The effectiveness of the intervention will be assessed at baseline (week 0), post-treatment completion (week 10), and 6 weeks post-treatment (week 16).

Expanded access of the iCBT module will not be available until after the study completion.


Eligibility Criteria:
Inclusion Criteria:

* be aged 18-59 years old;
* be screened as probable pathological gambler based on South Oaks Gambling Screen (SOGS);
* have access to electronic devices (ie, smartphone, mobile tablet, personal computer) with internet connection;
* be proficient in Indonesian language;
* have agreed to take part in the study by filling out the informed consent form.

Exclusion Criteria:

* have severe mental disorders or intellectual disabilities;
* have extreme agitation that hinder instrument fill out and adequate cognitive behavior therapy participation.