cyrilzakka/clinical-trials huggingface dataset:
Brain Network Analysis of Anesthesia Characteristics in Patients With pDoC Based on PSG

The goal of this prospective, exploratory and observational study is to learn about in healthy volunteers and patients with prolonged disorders of consciousness(pDoC). The main questions it aims to answer are:

1. Observe the similarities and differences of polysomnography between pDoC patients and healthy volunteers, and analyze the characteristic brain network changes based on polysomnography
2. To observe the similarities and differences of polysomnography in pDoC patients before and after Insertion of spinal cord electric stimulator under general anesthesia,and analyze the changes of anesthesia characteristic brain network in patients with consciousness disorders based on polysomnography.
3. To observe the similarities and differences of polysomnography in pDoC patients before and after spinal cord stimulation,and analyze the characteristic changes of brain network after spinal cord stimulation.

We will record the 8h polysomnography of healthy volunteers,record the polysomnography of DOC patients before and 24 hours after operation;and record the 24h polysomnography of patients with spinal cord electric stimulator.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria of health volunteer group:

  1. Aged 18-65, native Chinese
  2. No history of sleep apnea
  3. No history of insomnia
  4. Volunteer to participate in this study and obtain informed consent.
* Inclusion criteria of pDoC group:

  1. Aged 18-65, native Chinese
  2. pDoC after acquired brain injury
  3. The spinal electric stimulator was implanted under general anesthesia
  4. Obtain informed consent.
* Exclusion Criteria:

  1. Healthy volunteers took hypnotic drugs 72 hours before the study
  2. Continuous sedation treatment was carried out within 72 hours before the study
  3. The integrity of brain structures such as open head injury and brain parenchyma resection
  4. Intracranial compliance decreased due to hydrocephalus
  5. Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons
  6. Known or suspected to have serious heart, lung and kidney dysfunction
  7. Allergic history of sedative drugs
  8. Combined with other mental or nervous system diseases
  9. Other reasons are not suitable for this study.
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions

Pheochromocytomas and paragangliomas are neural crest-derived tumors of the nervous system that are often inherited and genetically heterogeneous. Genetic screening is recommended for patients and their relatives, and can guide clinical decisions. However, a mutation is not found in all cases. The aims of this proposal are to: 1) to map gene(s) involved in pheochromocytoma, and 2) identify genotype-phenotype correlations in patients with pheochromocytoma/paraganglioma of various genetic origins.

Pheochromocytoma and paragangliomas are tumors originated from neuroectoderm cells located in the adrenal or extra-adrenal paraganglia, often leading to increased secretion of hormones known as catecholamines. These tumors represent a potentially curable cause of hypertension and are malignant in about 10-15% of the cases. Approximately 40% of patients with pheochromocytomas and/or paraganglioma have an inherited mutation. In addition, some patients and/or their relatives that are mutation carriers can develop other tumors as part of inherited cancer susceptibility syndromes. Therefore, detection of the susceptibility mutation is important for diagnosis and follow up. However, the susceptibility gene mutation cannot be identified in all cases. Studies that aim to identify novel susceptibility genes for pheochromocytoma are required.

The fist aim of this study is to identify novel pheochromocytoma susceptibility genes. Characterization of such gene(s) can improve our understanding of the pathogenesis pheochromocytoma and paraganglioma and have an impact in diagnosis, therapeutic planning and genetic screening of relatives.

The second aim of this project is to characterize relationships between mutations and clinical features that can provide insights into clinical surveillance and screening of at-risk individuals.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of pheochromocytoma and or paraganglioma
* family member with diagnosis of pheochromocytoma and or paraganglioma
* diagnosis of a pheochromocytoma- and or paraganglioma-associated condition
* family member with diagnosis of a pheochromocytoma- and or paraganglioma-associated condition

Exclusion Criteria:

* unconfirmed diagnosis of pheochromocytoma and/or paraganglioma or associated condition
A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS

This is a randomized pilot study to characterize engraftment of a donor's microflora onto patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota transplantation.


Eligibility Criteria:
Inclusion Criteria:

* IBS with diarrhea
Alliance to Control Diabetes

Alliance to Control Diabetes was a 2.5-year study funded by the American Academy of Family Physicians Foundation. The study was designed to help patients better manage their diabetes, and was a partnership between the Institute for Behavioral and Community Health and Clínicas de Salud del Pueblo, Inc (CDSDP), a private, non-profit corporation providing comprehensive primary care services to residents throughout Imperial and Riverside Counties, California. The investigators identified 336 patients with uncontrolled diabetes from three CDSDP clinics. Patients were randomly assigned to intervention or control conditions. The 12-month intervention consisted of individual diabetes management support delivered by a trained volunteer peer supporter. The primary aim was determine if peer support can help patients better manage their diabetes and improve the quality of their lives. Intervention effectiveness was evaluated through volunteer and patient surveys at baseline, 6 months and 12 months. This study was part of the global Peers for Progress network which has been testing peer support programs in 13 countries.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years old
* Must be diagnosed with Diabetes Mellitus Type I, Diabetes Mellitus Type II or Gestational Diabetes
* Must be a resident of Imperial County
* Must be a current patient of Clínicas de Salud del Pueblo, Inc., at one of the three participating clinics
* Must speak Spanish and/or English
* Must plan on remaining in Imperial County for at least 12 months after enrollment into the study

Exclusion Criteria:

* Must not be involved in any other diabetes-related study
Use of 50% Nitrous Oxide / 50% Oxygen Premix During Liver Biopsy of Focal Lesion

A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of liver biopsy in order to relax him and to reduce his pain during this painful medical treatment. This single investigator centre and national clinical trial is done blindly : half of patients will receive 50% nitrous oxide / 50% oxygen premix and half of them a placebo gas (mixture of 50% oxygen and 50% nitrogen). 94 patients will be included in this clinical protocol.


Eligibility Criteria:
Inclusion Criteria:

* patient requiring a liver biopsy of focal lesion
* Age upper than 18 years
* OMS : 0 to 3
* patient consent form signed

Exclusion Criteria:

* patient unable to use Visual Analog Scale (VAS)
* OMS upper than 3
* coagulation disorder
* contraindication linked to the experimental product
* patient already included in another clinical trial uncompatible with this trial
The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)

To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.


Eligibility Criteria:
Inclusion Criteria:

* Memory complaint
* Mini Mental Status Exam (MMSE) score 24-28 inclusive
* General cognition and function performance sufficiently preserved such that a diagnosis of Alzheimer's disease (AD) cannot be made
* Generally healthy and ambulatory
* Sufficiently fluent in English

Exclusion Criteria:

* Diagnosis of probable or possible AD
* Neurological disorders
* History of malignant cancers
* Previously have taken donepezil or other acetylcholinesterase (ChE) inhibitors for more than 1 month or in the past 3 months prior to study entry
Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis

The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis.

This was a randomized, double-blind, active- and vehicle-controlled study comparing the effects of ME-609, acyclovir in ME-609 vehicle, and vehicle alone. Treatment was subject-initiated within 1 hour of experiencing the first signs or symptoms of a herpes recurrence. The subject visited a study clinic as soon as possible after treatment initiation, but no later than midnight of the following day, for evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Generally good health
* History of recurrent herpes labialis with at last three episodes during the prior 12 months

Exclusion Criteria:

* Treatment with antivirals or immunosuppressive agents within 2 weeks prior to randomization
* Pregnant and/or nursing women
* Continuous daily treatment with pain medication
* Significant skin condition that occur in the area of herpes recurrences
Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for people with body dysmorphic disorder.

Body dysmorphic disorder (BDD), a perceived defect in appearance (e.g., a "large" nose or facial "scarring"), is a relatively common disorder that causes marked distress and impairment in functioning. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs); however, response to SRIs is often only partial. About one third of patients do not respond to an SRI. Furthermore, patients may stop taking SRIs because of side effects (e.g., sexual side effects). For these reasons, additional monotherapy and SRI augmentation strategies are greatly needed.

Levetiracetam is primarily used as an antiseizure medication and has a wider safety margin than other antiepileptics. Preliminary scientific studies may suggest that it may be helpful for certain psychiatric symptoms and disorders. In the present study we propose to obtain pilot data on 1) levetiracetam monotherapy and 2) levetiracetam augmentation of SRIs in patients with BDD.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18-65;
* Current DSM-IV BDD or its delusional variant (delusional disorder, somatic type) for at least 3 months;
* A minimum total score of 20 on the Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) (19);
* Suitable for treatment in an outpatient setting

Exclusion Criteria:

* Unstable medical illness, including renal failure or dialysis;
* Myocardial infarction within 6 months;
* Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
* A need for prn benzodiazepines, another antiepileptic medication, or an anticipated change in the dose of any concomitant medications while receiving treatment with levetiracetam;
* Clinically significant suicidality, including a suicide attempt within the past two months;
* Lifetime history of DSM-IV dementia, schizophrenia, or any other DSM-IV psychotic disorder that is not attributable to BDD;
* Current or recent (past 3 months) DSM-IV substance abuse or dependence;
* Initiation of ongoing psychotherapy from a mental health professional within 3 months prior to study baseline;
* Ongoing cognitive-behavioral therapy from a mental health professional;
* Previous treatment with levetiracetam;
* Treatment with investigational medication, depot neuroleptics, or ECT within the past 3 months.
Compare the Knob-tipped Knife With the Needle Knife in Difficult Biliary Cannulation

The aim of the present study was to compare the efficacy and safety of the knob-tipped knife and needle knife for precut papillotomy in difficult common bile duct (CBD)cannulation.

Precut sphincterotomy is an alternative technique used to facilitate CBD cannulation following the failure of conventional bile duct cannulation. Needle knife papillotomy is the most widely practiced precut technique. However,Pre-cutting the papilla with a needle-knife is difficult, requiring experience and dexterity to control the axis and depth of the cut. Due to the increased rate of complications associated with this procedure, including pancreatitis, hemorrhage, and perforation, it was recommended to be performed only by experienced endoscopists.

The knob-tipped knife, a novel instrument utilizing a 2mm or 1.5mm cutting knife, is usually used for endoscopic submucosal dissection (ESD). Its knob-shaped tip and nonadjustable length make the knife less likely to slip and penetrate the tissue during the resection. Since the process of precut papillotomy is similar to ESD, the precutting procedure with the knob-tipped knife may be easier to be performed, as well as be safer. The efficacy and safety of this instrument in precut papillotomy have not been reported. We therefore assessed the efficacy and safety of the knob-tipped knife in precut papillotomy in difficult CBD cannulation.

Eligibility Criteria:
Inclusion Criteria:

* intact papilla and deep cannulation of the bile duct
* a standard wire-guided cannulation \>10 minutes, OR Pancreatic contrast injections ≥3, OR Pancreatic deep wire pass ≥5

Exclusion Criteria:

* ampullary tumors
* Billroth II or Roux-en-Y anatomy
* prior endoscopic sphincterotomy(EST) or biliary stent
* choledochoduodenal fistulae
Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy

False negative rate (FNR) in patients who has accepted neoadjuvant therapy is high. Blue dye and radioisotope as dual-tracer can decrease FNR. Several large clinical trials showed that using dual trace with blue dye and radioisotope can reduce the FNR to less than 10%. But radioisotope is still not approved in China and can cause radiocontamination. A novel dual-tracer which can decrease the FNR in patients after neoadjuvant therapy is urged to be explored. Contrast enhanced ultrasonography (CEUS) can make the lymphatic drainage path and sentinel lymph nodes visible. Retrospective studies found that CEUS can locate SLN precisely. So this clinical trial aim to evaluate FNR, detective rate and numbers of SLN by using CEUS combined with blue dye as dual-tracer in sentinel lymph node biopsy in breast cancer patients after neoadjuvant therapy and the accuracy of CEUS for the diagnosis of lymph node metastasis before and after neoadjuvant therapy.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old female；
* ECOG：0 - 1；
* Biopsy confirmed invasive breast cancer；
* cT1-4N0-3；
* Signed informed consent.

Exclusion Criteria:

* Inflammatory breast cancer；
* Received ipsilateral axillary surgery previously；
* During pregnancy.
Designed Music Narratives for the Reduction of Side Effects of Chemotherapy in Children (7-12 Years) With Cancer

The purpose of this study is to determine whether a specially-designed music-narratives are effective in reducing side effects of chemotherapy in 7- to 12-year-olds with cancer.

(Will be added later)

Eligibility Criteria:
1. Children at the ages 7-12
2. Four or five (dependent on their overall plan of medical treatment) consecutive courses of chemotherapy administrated at the involved child cancer units and (administered) over a period of minimum 24 hours incl. hydration with assumed moderate to severe nausea and vomiting.

   The specific type of chemotherapy may vary across the four/five consecutive courses but shall include one of the following moderate and/or highly emetogenic types of chemotherapy:

   Moderate emetogenic chemotherapy:
   * Carboplatin
   * Cyclophosphamide \<1500 mg/m2
   * Cytarabine \>1 g/m2
   * Daunorubicin
   * Doxorubicin
   * Epirubicin
   * Idarubicin
   * Ifosfamide
   * Mitoxantrone
   * Methotrexate \>1000 mg/m2

   Highly emetogenic chemotherapy:
   * Cisplatin \>25 mg/m2
   * Cyclophosphamide \>1500 mg/m2
   * Dacarbazine
3. Understand Norwegian/Danish
4. Parents must be able to read and understand Norwegian/Danish

   * No significant hearing impairment
   * Written and verbal informed consent from both possessors of the custody
   * Verbal informed consent from child/participant

Exclusion Criteria:

* Previous and/or acute psychiatric diagnosis
* Cognitive and mental deficits or impaired functioning
A Long-term Safety Surveillance Study in Participants Previously Treated With 177Lu-IPN01072

The purpose of the protocol is to evaluate the long-term safety of medicine 177Lu-satoreotide tetraxetan (also known as 177Lu-IPN01072 or 177Lu-OPS201) for patients who have previously received 177Lu-satoreotide tetraxetan in the clinical study OPS-C-001 / D-FR-01072-001.

The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection includes assessments/blood collection and on-site visits not necessarily part of routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Participant is capable of giving signed informed consent
* Participant must have received at least one infusion of 177Lu-IPN01072 in Study OPS-C-001

Exclusion Criteria:

- There are no exclusion criteria in this safety surveillance study.
A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis

The purpose of this study is to evaluate the drug levels, efficacy, and safety of Deucravacitinib (BMS-986165) in pediatric participants with juvenile psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria

* Participants must have been diagnosed with Juvenile Psoriatic Arthritis (JPsA).
* Participants must have at least three joints that are affected by arthritis.
* Participants must have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems.

Exclusion Criteria

* Participants must not have been diagnosed with JPsA before 5 years of age.
* Participants must not have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA,
* Participants must not have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months.
* Other protocol-defined Inclusion/Exclusion criteria apply.
The Study of Potency of Cross-preconditioning to Prevent Ischemic-reperfusion Injury for Heart Transplantation Recipient

In recent years, a large number of studies confirmed the protective effect of ischemic preconditioning on myocardium against ischemia/reperfusion injury, but the clinical data of the effectiveness of ischemic preconditioning in heart transplantation is still missing. Inspired by the promising data of ischemic preconditioning from the previous reports, the investigators firstly introduce a novel method of cross ischemic preconditioning technique to prevent ischemia/reperfusion injury to heart transplant recipients.

This study will evaluate whether this cross-preconditioning technique would attenuate ischemia/ reperfusion injury to the heart transplant recipients, reduce Intensive Care Unit(ICU) and total hospitalization stays and the incidence of cardiovascular adverse events and improve the long-term survival outcomes.

Patients receiving heart transplantation are randomly assigned into the cross ischemic preconditioning (CICP) intervention group and the control group. (the Statistical Analysis System (SAS) software was used to generate a random number table and randomly divided into two groups). After the establishment of the cardiopulmonary bypass, the ascending aorta of the CICP group will be crossclamped 2 minutes, separated by a 3-minute rest interval, and repeated successively on 2 occasions.

The recipients in the control group are to undergo routine cardiopulmonary bypass procedure of heart transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent heart transplantation；
2. Signed informed consent.

Exclusion Criteria:

1. Systemic active infection;
2. Refractory respiratory failure or renal failure;
3. Severe systemic diseases with limited survival time.
4. ABO blood groups incompatibility
5. positive serum HIV antibody;
6. drug or alcohol abusing;
7. Mentally ill;
8. Recent history of severe pulmonary embolism
9. Have not signed informed consent.
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that lead to a decrease in the blood level of functional "C1INH". This multi-center study was designed to assess the safety and tolerability, efficacy, and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema attacks.

Funding Source - FDA OOPD

A prospectively planned interim analysis will be performed on the double-blind data.

Eligibility Criteria:
Main Inclusion Criteria:

* Clear clinical and laboratory diagnosis of HAE
* Plasma level of functional C1INH of less than 50% of normal
* Acute abdominal, urogenital, peripheral, and/or oro-facial/pharyngeal/laryngeal HAE attack

Main Exclusion Criteria:

* Acquired angioedema
* Pregnancy or breastfeeding
* Treatment with any investigational drug within prior 30 days
* Body weight \>120 kg
A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
* inadequate response to a stable dose of MTX;
* patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

* major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
* prior treatment failure with an anti-tumor necrosis factor agent;
* women who are pregnant or breast-feeding.
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans

The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.


Eligibility Criteria:
Inclusion Criteria:

* at least one lifetime exposure to cannabis
* good physical and mental health

Exclusion Criteria:

* cannabis naive individuals
* major current or recent stressors
* taking estrogen supplements or oral contraceptive pills (for women)