cyrilzakka/clinical-trials huggingface dataset:
Subsensory Sacral Nerve Stimulation for Irritable Bowel Syndrome

Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies have shown changes in both colonic motility and rectal sensibility. We have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, we aim to evaluate if subsensory sacral nerve stimulation is as effective as suprasensory sacral nerve stimulation.

Twenty four patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled in the study.

Having meet inclusion criteria, the patients are randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 2+2-week period followed by 2 weeks of suprasensory stimulation. Hereby rendering a percutaneous nerve evaluation (PNE) test of a total of 6 weeks.

During the PNE test the effect of the stimulation is evaluated by specific IBS symptom and quality of life questionnaires (GSRS-IBS and IBS-IS) and bowel habit diaries.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18
* Patients who are psychologically stable and suitable for intervention and able to provide informed consent.
* Patients who are diagnosed with IBS-D or IBS-M according to the Rome III criteria
* Minimum average of 40 points in the symptom quistionnaire evaluated at baseline

Exclusion Criteria:

* Overt bowel diseases including inflammatory bowel disease
* Pregnant or breast feeding
* Patients who are considered unable to follow the planned programme of the study, including mentally illness or physiological instability
* Patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological disease
Reducing Stigma and Increasing Treatment Seeking Intentions Among Adolescents

Depression is a leading cause of illness and disability in teenagers. Longer duration of untreated depression (DUD) is associated with greater severity, poorer outcome, and cognitive impairment. Stigma toward people with depression has been identified as a barrier to seeking help; therefore, reducing stigma toward young people at depressive risk could enhance their receptivity to seeking treatment. Social contact is a form of interpersonal contact with members of the stigmatized group and the most effective type of intervention for improvement in stigma-related knowledge and attitudes.

In a prior study, the investigators developed short video interventions to reduce stigma and increase treatment seeking among adolescents with depression. The videos feature adolescent protagonists varied by race/ethncitiy and gender (Black girl, Black boy, White girl, White boy, Hispanic girl, Hispanic boy, nonbinary or transgender adolescent) who will share their experiences with depression, challenges, and recovery process. The investigators would like to conduct a randomized controlled trial (RCT) to test the efficacy of these tailored videos as compared to a video control condition (which provides information about depression and how to seek help but does not include a personal story) on reducing self-stigma and increasing help-seeking intentions and behavior at baseline, post, 2 week follow-up, and 4 week follow-up among adolescents ages 14-18 recruited via Cloudresearch. The videos will be shown again at 2 week follow-up.

In a randomized control trial (RCT) with pre-, post-intervention, and 2 and 4 week follow-up assessments, the investigators aim to test the efficacy of brief social contact video interventions, varying protagonist race/ethnicity, as compared to video control in reducing depression related stigma and increasing treatment-seeking intentions and behavior among adolescents ages 14-18 recruited via Cloudresearch, a crowdsourcing platform. The control condition will include a video that will provide information about depression and how to seek help but does not include a personal story. The tailored video interventions will be assigned based on participant demographics and will include adolescent protagonists varied by race/ethnicity and gender (Black girl, Black boy, White girl, White boy, Hispanic girl, Hispanic boy, nonbinary or transgender adolescent). Videos will be shown at baseline and 2 week follow-up. The investigators hypothesize that 1) Brief social contact-based video interventions will reduce stigma towards depression and increase treatment-seeking intentions and behavior compared to video control which provides information about depression and help seeking but does not include a personal story.

Eligibility Criteria:
Inclusion Criteria:

* Ages 14-18
* English speaking
* US Residents

Exclusion Criteria:

* Age less than 14 or greater than 18
* Non-English speaking
* Non-US Resident
Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy

The aim of this research is to use a controlled laboratory setting to determine whether bacteria isolated from kidney stones of patients play a role in the formation of non-infectious kidney stones. It is well known that struvite stones are associated with active bacterial infection, however the role of bacteria in the formation of non-infection stones (like calcium oxalate) is not well characterized and there are theories that bacteria are involved in the making of these stones.

Kidney stone disease is common, affecting nearly 10% of the population with increasing prevalence and increasing cost associated to treat this disease. While struvite stones (composed of magnesium, ammonium and phosphate crystals) have been associated with the presence of infection, the association between bacteria and non-infection stones is not well characterized. Previous studies have found bacteria present in stones of patients without active infection and with negative pre-operative urine tests.

There are various compositions of kidney stones, including calcium oxalate, calcium phosphate, struvite and uric acid, with calcium oxalate being the most common. It is well known that struvite stones are associated with active infection, however the role of bacteria in the formation of other types of kidney stones, including calcium oxalate, is not well understood. The investigators hypothesize that bacteria present in the urinary tract of patients without active infection have the ability to facilitate calcium oxalate crystal formation by providing a surface for stones to grow. An understanding of the role of bacteria in the formation of non-infection stones could help prevent stone formation by altering the bacteria present within patients to decrease or eliminate their risk of kidney stone disease.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Diagnosed with or have a high index of suspicion of having a kidney stone and scheduled to undergo percutaneous nephrolithotomy.
* Medically fit for definitive surgical management of stone

Exclusion Criteria:

* Those with medical comorbidities preventing them from safely undergoing definitive surgical therapy.
* Patients who are unable to provide informed consent.
* 18 years old or younger
* Diagnosed with an infection stone
* Urinary tract infection within 3 months before date of operation
* Antibiotic use within 3 month before date of operation
NGS and TME for Evidence-based Treatment of Pancreatic Cancer

The tumor tissue of patients with pancreatic cancer will be submitted to next-generation sequencing (NGS) and these data will be evaluated with an oncology treatment decision support (TDS) software tool that is a medicinal product class 1 (CE-marked). This software will make evidence-based suggestions for drugs likely to be effective, ineffective, or toxic (FDA approved biomarkers). For patients fit for second-line therapy, the resulting recommendations will be judged by the tumor board.

Tumor tissue of patients (surgical resection, biopsy) will be used for SWEDAC-certified DNA extraction and NGS. Pseudonymised sequencing data will be fed into a TDS software tool (TreatmentMAP™, Molecular Health) and based on published evidence, suggestions will be made, graded into NCCN categories of approved drugs in indication or otherwise, clinical evidence or experimental. Same with anticipated inefficacy. In addition, FDA-approved biomarkers for toxicity will be analysed. This information is taken to the tumor board for making a decision whether this information is useful and eventually to recommend a treatment for a given patient.

Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18 years up to 75 years
* Patient willing and able to provide informed consent
* TreatmentMAP™ NGS/TME is ordered by the tumor board (MDT) under routine clinical practice
* Diagnosis of a locally advanced, inoperable or metastatic pancreatic carcinoma, clinically and histologically verified according to the currently prevailing standards.
* Patient received first line therapy according to applicable guidelines and/or standards (SoC)
* Sufficient testing material available (e.g. tumor biopsy) to allow NGS/TME NGS panel testing.

Exclusion Criteria:

* Patients with ongoing systemic infection,
* Patients with immunodeficiency,
* Patients with severe cardiovascular and pulmonary morbidity that might interfere with or preclude further systemic anticancer treatment,
* Patients on full therapeutic anticoagulation.
* Patients who, due to their clinical status, are not eligible for further systemic anticancer therapy (chemotherapy, immunotherapy etc.)
* Patients who, due to their disease status are in need of immediate therapy and cannot wait for the result of the NGS/TME process.
Effects of Fructose Restriction on Liver Steatosis

Nonalcoholic fatty liver disease (NAFLD) is an emerging health problem as it can lead to end stage liver failure and cardiovascular complications. Diet play an important role in the development of NAFLD. Many studies have addressed the effects of added fructose on NAFLD. To date, little attention has been paid to the effects of a diet devoid of fructose. Therefore, the investigators aim to study the effects of fructose restriction on hepatic fat accumulation and vascular function using a double-blind randomized placebo-controlled design.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Body mass index ≥ 28 kg/m2
* Fatty liver index ≥ 60
* Fructose intake ≥45 grams/day

Exclusion Criteria:

* Medical history of liver disease
* (History of) excessive alcohol consumption (defined as \> 2 units/day for women, and \> 3 units/day for men)
* Major change in weight and/or physical activity prior to the study
* Use of glucose lowering drugs
* Recent illness
* Pregnancy and/or lactation
* Contraindications for magnetic resonance imaging
* Inability to give informed consent

Protocol change (implemented on July 18, 2018): in order to increase the inclusion of study participants, subjects with an average daily fructose intake \< 45 gram/day will also be eligible for participation. In subjects who have an average daily fructose intake \< 45 gram/day, supplementation of either fructose or glucose (see 'Arms and Interventions') will be increased to 45 gram/day.
BPL-003 Efficacy and Safety in Treatment Resistant Depression

This is a Phase 2 study randomized, quadruple masked, multi-center study , with a Open Label Extension, designed to investigate the efficacy and safety of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).

Approximately 200 eligible participants will receive a single dose of either low, medium, or high doses of BPL-003, given intranasally, with 8 weeks of follow up assessments. Following this participants may receive a second dose of either monophasic or biphasic dose of BPL-003, given intranasally, with another 8 weeks of follow up assessments.

Psychological support will be given before, during and after each dosing.

Eligibility Criteria:
Inclusion Criteria:

1. At least moderate major depressive disorder.
2. Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments based on the MGH ATRQ assessment.
3. Hamilton Depression Rating Scale score ≥19 at Screening and Baseline.
4. CGI-S ≥4 at Screening and Baseline.
5. If currently taking antidepressant medications, willing and able to discontinue current antidepressants.

Exclusion Criteria:

1. Current or past history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
2. Current personality disorders.
3. First-degree family history of schizophrenia, bipolar disorder, delusional disorder, or schizoaffective disorder.
4. Current alcohol or substance use disorder (other than caffeine or nicotine).
5. A participant who at any time has been unresponsive to ketamine, esketamine, an adequate course of treatment with electroconvulsive therapy, or has received vagal nerve stimulation or deep brain stimulation.
6. Suicidal ideation or behavior within the 12 months prior to the start of Screening or on Day 1 prior to dosing.
7. Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.
8. Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
9. History or current uncontrolled hypertension.
10. Seizure disorder or any seizure in the 2 years prior to Screening.
11. Has clinically significant results on ECG during the Screening.
12. Any nasal obstruction, blockage, or symptoms of congestion at the time of dosing that in the investigator's opinion may interfere with the administration of the study medication.
13. Female participants who are pregnant, lactating, or of childbearing potential and not willing to use adequate forms of contraception during the study.
14. Male participants who are sexually active and not willing to use adequate forms of contraception during the study.
Subarachnoid-Subarachnoid (S-S) Bypass Versus Adhesion Lysis in Spinal Arachnoiditis and Syringomyelia

To determine whether Subarachnoid-Subarachnoid (S-S) Bypass results in better patient outcomes with fewer complications and improved quality of life compared to intradural adhesion lysis in individuals with Spinal Arachnoiditis and Syringomyelia.

Participants with Spinal Arachnoiditis and Syringomyelia will be randomized to either have a Subarachnoid-Subarachnoid (S-S) Bypass or intradural adhesion Lysis. The participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: 3-6 months, 12 and 24 months. At these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete questionnaires. A spine MRI will be performed 3-6 months, 12 and 24 months after the decompression.

Eligibility Criteria:
Inclusion Criteria:

* 1) history of traumatic spinal cord injury or other infection; 2) evidence of progressive neurological deficit, and/or pain syndrome; 3) MRI showing a syringomyelia due to spinal trauma or other infection; and 4) minimum follow-up period of more than 1 year.

Exclusion Criteria:

* Chiari-malformation, myelomalacia, subarachnoid cyst, syringomyelia due to other spinal diseases (such as degenerative spinal disease)
Effect of Micronutrient Supplementation on Nerve Conduction Velocity in T1D- RCT

Type 1 diabetes can complicate to peripheral neuropathy due to preferential involvement of small unmyelinated nerve fibers (pain and temperature sensation) followed by myelinated nerve fibers (vibration and proprioception). The SEARCH for diabetes in youth study found diabetic neuropathy in 7% of T1D youth. The clinical form of peripheral neuropathy is rare in childhood and pathophysiological changes begin during childhood and accelerate in puberty. Adolescents with these changes can be picked up more reliably by electrophysiological studies than by clinical examination. Nerve conduction studies are the gold standard diagnostic tests for detection of peripheral neuropathy. Role of vitamin B12 in nerve regeneration is well known while causal association of vitamin D deficiency in type 1 diabetes and its role in axonal degeneration is also reported. The previous ongoing studies from authors' group have shown relationship between poor oral iron intake and subclinical neuropathy in children with type 1 diabetes (manuscript in submission). The present randomised clinical trial is aimed at assessing vitamin B12, vitamin D and iron supplementation for improvement of nerve conduction velocities in children and youth with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Children/ parents/ youth willing to participate in the study with an informed consent/ assent.
2. Children/ youth Age \> 10 years
3. Diabetes duration \> 2 years
4. Diagnosed with type 1 diabetes

Exclusion Criteria:

1. Age \< 10 years
2. Diabetes duration \< 2 years
3. Children/ youth receiving vitamin B12, vitamin D and/or oral iron supplements
4. Children/ youth with any other disease condition involving nerve or muscle function
5. Children/ parents/ youth not willing to consent to participate in the study.
Microtransplantation for Advanced and Relapsed Solid Tumors

In this study, we will apply micro transplantation to the field of solid tumors to study the efficacy and safety of radiotherapy and chemotherapy combined with micro transplantation in the treatment of advanced / relapsed solid tumors.

The eligible patients are assigned to the experimental group (microtransplantation group, MST group) or the control group (CT) according to the availability of suitable donors. In MST group, peripheral blood hematopoietic stem cells from HLA mismatched donors mobilized with granulocyte colony stimulating factor are infused after conventional chemotherapy and/or radiotherapy ; The CT group only received conventional chemotherapy and/or radiotherapy. According to the patient's past medical history, current tumor assessment results, and the latest cancer treatment guidelines, the individualized chemotherapy and / or radiotherapy plan for the patient is formulated after discussion by more than 3 oncologists. After each course of treatment, the efficacy and safety are evaluated. For the patients who are evaluated to be effective or stable (SD) after the first treatment, the second treatment of the same scheme will be given. Those who reach the disease control level will continue to be treated for 4 courses, with an interval of 28 days. The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study. Patients are allowed to receive any treatment, including symptomatic support treatment, after the end of treatment or withdrawal from the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients are 18-80 years old, regardless of gender or race;
* Advanced / relapsed solid tumors (small cell lung cancer, ovarian cancer, cervical cancer, gastric and colorectal cancer, sarcoma, head and neck tumor, etc.) are confirmed by clinical or histopathological diagnosis;
* More than two kinds of tumors are allowed;
* Karnofsky score ≥ 60, ECoG physical status ≤ 2;
* Sensitive to chemotherapy or radiotherapy;
* There are measurable lesions;
* There are suitable hematopoietic stem cell donors

Exclusion Criteria:

* have no suitable donor or donor refused
* patient refused to accept donor cells
Pressure Gradient for Venous Return in Predicting Fluid Responsiveness in Patients Undergoing Laparoscopic Surgery

Surgical patients, especially those with insufficient blood volume and hypotension, often need fluid therapy. However, there is still a lack of simple and reliable indicators for judging transfusion responsiveness in some types of surgery. Previous studies have shown that Pressure Gradient for Venous Return (PVR) can be used to guide infusion. Thus, our aim is to explore the relationship between PVR and liquid reactivity.

Fluid resuscitation is one of the key issues in the management of surgery and anesthesia. Fluid infusion test is a method to determine patients' reactivity to liquid therapy. The commonly used Stroke Volume Variation (SVV) and Pulse Pressure Variation (PPV) are good predictors of fluid responsiveness, but they are not suitable for operations with increased intra-abdominal pressure, such as laparoscopy surgery. Some studies have shown that Pressure Gradient for Venous Return (PVR) may has the same effect as PPV/SVV in predicting fluid responsiveness (FR). In the case that PPV/SVV cannot be used, PVR may be used alternatively. Therefore, our aim is to explore the relationship between the changes of PVR and fluid responsiveness during liquid infusion and to determine relevant parameters.

We will choose patients planed to receive laparoscopic surgery and general anesthesia, especially the patients with gastrointestinal tumors because of generally long operation time and much infusion volume. In our hospital, these patients will routinely indwelled arterial catheters and deep venous catheters during the operation. The former is mainly used to monitor direct arterial pressure, and the latter is used for fluid infusion.Through the above two pathways, we can collect the hemodynamic parameters of patients, and then establish the relationship between PVR and FR.

In our study, a good FR was defined as a 10% increase in cardiac index (CI) after fluid infusion, and PVR is calculated by a special formula based on some specific parameters of hemodynamics.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing laparoscopic surgery and general anesthesia

Exclusion Criteria:

* cardiac insufficiency; severe arrhythmias; patients using intra-aortic balloon pump; use of left ventricular assist devices; spasm of peripheral arteries caused by some factor
mRNA Based-Covid-19 Vaccine Effects on Blood Glucose Levels

To determine if patients with a history of Diabetes Mellitus Type I or II developed a change in blood glucose levels as reported on Continuous glucose monitoring devices (CGMS) within the first week following administration of each dose of the COVID-19 vaccine.

A retrospective review of all patient data from the Dexcom and Libre CGMS devices available at a single site, solo endocrinology practice will be obtained. This data will include fasting morning glucose, postprandial glucose, and daily glucose area under the curve for seven days following vaccination administration, as well as daily glucose area under the curve seven days prior to vaccine administration that will be used as a control. Patients \>=18 y/o with a history of Diabetes Mellitus Type I or Type II will be selected. Brand of vaccine administered (Moderna or Pfizer-BioNTech) and the change in average blood glucose, peak blood glucose, and percentage of time spent in normal range as well as above average range of blood glucose level following vaccine administration will be assessed. Patients will fill out a visual analog symptom scale based on how symptomatic and uncomfortable they were following each dose of the COVID-19 vaccine. Patients will describe side effects that they experienced following each dose of the COVID-19 vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Diabetes Mellitus Type I or Type II
* Received the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine

Exclusion Criteria:

* Patients \<18y/o.
* Patients that did not receive a COVID-19 vaccine.
* Patients who did not have a CGMS downloaded for a week prior and a week after vaccination.