cyrilzakka/clinical-trials huggingface dataset:
Neuropathic Pain and Operant Conditioning of Cutaneous Reflexes After SCI

The purpose of the second part of the study is to examine the effect of reflex training in the leg to decrease neuropathic pain. For this, the researchers are recruiting 15 individuals with neuropathic pain due to spinal cord injury to participate in the reflex training procedure. The study involves approximately 50 visits with a total study duration of about 6.5 months (3 months for baseline and training phases followed by 1 month and 3 month follow-up visits).

As part of the larger study of the relationship between reflexes in the leg and the presence of neuropathic pain, the researchers are also recruiting 30 individuals with spinal cord injury (SCI) total, 15 individuals with neuropathic pain due to SCI and 15 individuals without neuropathic pain. For this portion of the study, there are 2 visits. The first visit will examine cutaneous reflexes in the leg. During the second visit, the study team will assess sensation in the leg and administer questionnaires about pain, functioning, and quality of life. This portion of the study does not involve an intervention.

The study will then recruit 15 individuals who will participate in reflex training, as described in the brief summary.

Eligibility Criteria:
Inclusion Criteria:

1. neurologically stable (\>1 year post SCI)
2. medical clearance to participate
3. ability to stand with or without an assistive device for at least 3 minutes at a time
4. expectation that current medication will be maintained without change for at least 3 months (stable use of anti-spasticity medication is accepted)
5. For participants with neuropathic pain, the area of neuropathic pain must include lower leg.

Exclusion Criteria:

1. motoneuron injury
2. known cardiac condition
3. medically unstable condition (incl. pregnancy)
4. cognitive impairment
5. uncontrolled peripheral neuropathy
6. frequent use of electrical spinal stimulation (either transcutaneous or epidural) for pain treatment
7. daily use of electrical stimulation to the leg
8. complete lack of cutaneous sensation around foot.
Effect of Preop and Postop ESP Block on Analgesia, Hemodynamics and Patient Satisfaction in Laparoscopic Cholecystectomy

Erector spinae plane (ESP) block is an interfascial plane block applied to the paraspinal region, which provides effective visceral and extensive somatic analgesia by providing paravertebral spread of the administered local anesthetic to three and four vertebral levels cranial and caudal. ESP block is a new regional anesthesia method applied with ultrasound (USG) guidance to provide analgesia for various surgeries and for acute or chronic pain. The application of this block is simple and can be performed in the preoperative waiting area with light sedation or no sedation. ESP block can be applied with a single injection or as a continuous infusion by catheter placement.

Erector spinae plane (ESP) block is an interfascial plane block applied to the paraspinal region, which provides effective visceral and extensive somatic analgesia by providing paravertebral spread of the administered local anesthetic to three and four vertebral levels cranial and caudal. ESP block is a new regional anesthesia method applied with ultrasound (USG) guidance to provide analgesia for various surgeries and for acute or chronic pain. The application of this block is simple and can be performed in the preoperative waiting area with light sedation or no sedation. ESP block can be applied with a single injection or as a continuous infusion by catheter placement. The first report related to this block was published in 2016; the block was performed to reduce thoracic neuropathic pain in a patient with metastatic rib disease and rib fracture. So far, the block has been reported to be performed successfully in many cases, including the Nuss procedure, thoracotomies, percutaneous nephrolithotomies, ventral hernia surgeries, and even lumbar fusions.

Eligibility Criteria:
Inclusion Criteria:

* According to the physical classification of the American Society of Anesthesiologists (ASA), ASA I-II group,
* between the ages of 18-65,

Exclusion Criteria:

* Patients who do not want to participate in the study;
* BMI \>30,
* Patients with contraindications for ESP block,
* Uncooperative patients,
* Those with renal failure,
* Those with hepatic failure and
* ASA III-IV-V group patients
Role of OMT in the Management of the Persistent Post-COVID-19 Symptoms

The goal of this observational study is to determine the feasibility of conducting a large-scale study on the effect of using osteopathic manipulative treatment (OMT) to treat patients with post-COVID-19 symptoms. The main questions it aims to answer are:

1. Is it feasible to conduct a large-scale study of the effect of OMT on patients with post-COVID-19 symptoms (based on how many patients agree to participate and how many complete the study)?
2. How much change in patients' post-COVID-19 symptom severity, quality of life, and ability to return to work can we expect to see following OMT?

Participants will receive OMT as directed by their physician and complete questionnaires after every other OMT session.

1. Participants will complete questionnaires about their post-COVID-19 symptoms, quality of life, ability to return to work, and adverse events they experienced 3 days after every other OMT session.
2. Participants will be sent links to the questionnaires for 4 months or when their symptoms resolve, whichever comes first.
3. Additionally, participants will complete a follow-up questionnaire 2 months after they stop receiving OMT for their post-COVID-19 symptoms or 6 months after enrollment in the study, whichever comes first.


Eligibility Criteria:
Inclusion Criteria:

* at least one symptom of post-COVID-19 (eg, fatigue, dyspnea, anosmia, arthralgia, headache, sleep disturbances, anxiety/depression, or other problems related to mental health) which was new after diagnosis with COVID-19 and has persisted for at least 4 weeks after diagnosis

Exclusion Criteria:

* unable to speak, read, and write in English
* not mentally competent to give informed consent
* inability to complete surveys/questionnaires online
Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)

To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent IVF

Exclusion Criteria:

* Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus
* Pregnant or possible pregnant women, or lactating women
* Patients with undiagnosed atypical vaginal bleeding
* Patients with a history of hypersensitivity to any of the ingredients of this product.
* Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease
Dose-Response Study of Probiotic Bacteria BB-12 and CRL-431 in Healthy Young Adults

The purpose of the study was to investigate the dose-response effect of increasing doses of Bifidobacterium animalis ssp lactis (BB-12) and Lactobacillus paracasei ssp paracasei (CRL-431) on the immune response, blood lipids, gut microflora, recovery from feces and overall tolerance in healthy young adults.

The study included seventy-one healthy young vounteers, and was designed as a double-blind placebo controlled dose-response trial based on a 2 wk run-in period, a 3 wk intervention and 2 wk wash-out period. The subjects were randomly assigned into 5 groups of 15 subjects each, who were supplemented with 0, 10E8, 10E9, 10E10 or 10E10 CFU/d, respectively, og a mixture of BB-12 and CRL-431. Blood samples were collected 4 times and fecal samples 3 times. Diary reporting bowel habits and weel being was kept for all 7 weeks.

There are very few articles concerning the issue dose-response effect of probiotics.The aim of the study was to investigate the dose-response effect of increasing concentrations of probiotics on the immune response, blood lipids, composition of the gut microflora, recovery from feces and the overall tolerance.

The hypothesis was that the increasing dose would influence the immunresponse (eg incresae phagocytosis), improve blood lipid profile (eg.lower HDL-cholesterol), would be recovered in increasing concentrations in feces, would change the intestinal microfloraprofile and would be well tolerated even in high doses.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young individuals

Exclusion Criteria:

* GI-disease
* Colosomi
* Pregnant or lactating women
* Allergy
* Individuals receiving the following medicine: antacid, antibiotics, steroids, medicine with influence the intestinal function.
Using Saline for Myofascial Pain Syndromes (USAMPS)

This study involves adult patients diagnosed with Myofascial Pain Syndromes (MPS). The purpose of this research study is to determine if there is a therapeutic difference between trigger point injection (TPI) of normal saline and conventional drug mix (local anesthesic + steroid) in treating MPS.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients diagnosed with MPS of the trapezius, gluteus medius/minimus, iliocostalis thoracis-lumborum, quadratus Lumborum, or paraspinal muscles in the emergency department.

Exclusion Criteria:

* Patients allergic to lidocaine and/or steroids.
* Pregnant women.
* Prisoners.
* Patients who are cognitively impaired and/or unable to consent for the study.
* Age \< 18.
* Signs of localized infection or skin breakdown at the injection site.
ICG vs Blue Patent for TAD in cN1 Breast Carcinoma After Neoadjuvant Chemotherapy

To validate the use of ICG as a tracer during TAD in patients with cN1 breast carcinoma after neoadjuvant chemotherapy.

This patient registry is designed to prospectively collect standardized clinical, imaging, surgical, and pathological data from patients with cN1 breast carcinoma undergoing targeted axillary dissection (TAD) following neoadjuvant chemotherapy, using indocyanine green (ICG) as a lymphatic tracer.

To ensure data quality and consistency the following procedures and quality control measures will be implemented:

Standardized Case Report Forms (CRFs):

All data will be recorded using electronic CRFs developed specifically for the registry. These forms are structured to capture relevant demographic, clinical, radiological, surgical, and pathological variables, including tracer detection rates, number of retrieved nodes, false-negative rates, and complications.

Center Training and Accreditation:

All participating surgeons and radiologists will receive training on standardized procedures for TAD using ICG, including injection technique, intraoperative fluorescence detection, and specimen handling. Regular inter-institutional meetings will be held to reinforce protocol adherence.

Quality Assurance in Imaging and Pathology:

Lymph node localization procedures (e.g., clip placement, imaging review) and histopathological analyses will follow unified protocols.

Ethics and Patient Confidentiality:

All data will be de-identified and managed in compliance with GDPR and local data protection regulations. Informed consent will be obtained from each participant prior to data inclusion.

Follow-up and Outcome Tracking:

The registry will track short- and mid-term surgical outcomes, including detection rates, surgical complications, and axillary recurrence, ensuring longitudinal quality assessment of the ICG-guided TAD approach.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer cN+ patients who undergo neadjuvant treatment.

Exclusion Criteria:

* Patients in whom there is a contraindication for the use of ICG.
* Patients in whom there is evidence of progression of the disease after neoadjuvant treatment.
Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy

The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-breast feeding female ≥ 18 years old
* In remission from demonstrated overt HE
* Had ≥1 episode of overt HE associated with liver disease within the last 6 months
* MELD score of ≥ 19
* Has a close family member or other personal contact who is familiar with the subject's HE, can provide continuing oversight to the subject and is willing to be available to the subject during the conduct of the trial

Exclusion Criteria:

* HIV
* History of tuberculosis infection
* Chronic respiratory insufficiency
* Current infection and receiving antibiotics
* Renal insufficiency requiring dialysis
* Active spontaneous bacterial peritonitis infection
* Intestinal obstruction or has inflammatory bowel disease
* Active malignancy within the last 5 years
* Current GI bleeding or has had a GI hemorrhage within past 3 months
* Anemia
The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy

To compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan criteria BCLC stage A/B HCC who underwent hepatectomy.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS≤1;
* proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
* not previous treated for tumor;
* the tumor was diagnosed as BCLC stage A/B and beyond Milan criteria;
* no distant metastasis;
* the lab test could meet:

  * neutrophil count≥2.0×109/L;
  * hemoglobin≥100g/L;
  * platelet count≥75×109/L;
  * serum albumin≥35g/L;
  * total bilirubin\<2-times upper limit of normal;
  * ALT\<3-times upper limit of normal;
  * AST\<3-times upper limit of normal;
  * serum creatine\<1.5-times upper limit of normal;
  * PT≤upper limit of normal plus 4 seconds;
  * INR≤2.2;
* sign up consent.

Exclusion Criteria:

* cannot tolerate TAI or surgery;
* distant metastasis exits;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrhage or cardiac/brain vascular events within 30 days;
* pregnancy.
Work Breaks During Simulated Minimally Invasive Surgery

Minimally invasive surgeons have a prevalence of work-related musculoskeletal complaints of up to 86% due to the exposure to static loading, awkward postures, work pressure, and patient's wellbeing. Researchers have developed postural interventions to counteract the prevalence of musculoskeletal complaints and disorders, such as robot-assisted surgeries, arm-support systems, and rotatable handle pieces. An alternative intervention is to implement work breaks during the surgeries, which has shown to give promising results including that surgery duration does not prolong.

The aim of the current study is to simulate 90-min laparoscopic surgery activities in the laboratory and compare two intervention situations with the control situation. The control situation is without work breaks. The two intervention situations include 2.5-min breaks provided two times, i.e. after every 30-min work period, which are passive (rest) or active (targeted mobilization exercises). The assessment is based on changes in muscular activity on the back and upper extremities, back and upper extremity postures, feelings of discomfort, and work performance.


Eligibility Criteria:
Inclusion Criteria:

* (Student) surgeons, who are familiar with laparoscopic procedures and / or simulated laparoscopic procedures;
* Be able to perform the Peg-Transfer task (Simulab, Seattle, WA, USA) within 3 minutes;
* The participant will give her/his voluntary informed consent after receiving oral and written information of the content and goal of the study.

Exclusion Criteria:

* (Student) surgeons who are not familiar with laparoscopic procedures and / or simulated laparoscopic procedures;
* Not able to perform the Peg-Transfer task within 3 minutes;
* People under the influence of intoxicants, analgesics, or muscle relaxants;
* Alcohol abuse;
* People with cardiovascular diseases;
* People with a heart pacemaker;
* People with a disability who, due to their restriction at a workplace of this kind, will not be able to participate;
* People with Diabetes Mellitus;
* People with severe muscle contractions of the lower extremities, back or arms;
* People with acute ailments or pain, which make(s) them unable to participate;
* People who are unable to complete the examination program due to language or cognitive obstacles;
* Depending on the degree of severity, people with diseases of the veins and joints of the lower extremities, spine, muscle disorders, symptomatic neurological-psychiatric diseases, acute pain syndromes, maladies or other current diseases.
Post-marketing Surveillance (Use Result Surveillance) With Refixia®

The participants are invited to take part in this study because they have Haemophilia B. The purpose of this study is to assess the safety and effectiveness of Refixia® about long-term routine use in patients with Haemophilia B. The participants will get Refixia® as prescribed to them by their study doctor. The study will last up to Sep 2025 for the participant. The participants may be asked to fill in the quality of life questionnaires (if they are above age of 15). The blood samples taken from the participants as part of routine clinical practice will also be used to investigate the safety for the long-term use of Refixia®.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available Refixia® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. At each site of this study, all patients will be registered consecutively from the first patient after the launch of Refixia® (consecutively registered system).
* Diagnosis of haemophilia B in males or females, no age limitation. Patients younger than 12 years old will continue to be registered for 3 years of recruitment period regardless of the target number of patients.
* New patients who have not been previously exposed to Refixia®. Also patients previously exposed to Refixia® in NN7999-3639, -3747, -3774, -3775 or -3895 clinical trial can be enrolled in this study. The patients who have participated in NN7999 -3774 or -3895 clinical trial can be enrolled in this study as continuous cases until 30-September-2024 (one year before planned end of study date).

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Known or suspected hypersensitivity to study product or related products.
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis

A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP)


Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed diagnosis of PPP
* Disease duration of at least 6 months prior to screening
* Present with active pustules on palms or/and soles at screening

Exclusion Criteria:

* Any other ongoing inflammatory disease that interfere with the investigator's ability to evaluate the subject's response to therapy
* History of recurrent or active/serious infection
* Ongoing use of psoriasis prohibited medication

Other protocol-defined inclusion/exclusion criteria may apply
Sequential Versus Simultaneous Pneumococcal Vaccination in Elderly: Immunological Memory and Antibody Levels

The purpose of the present study is to compare the immunological response of pneumococcal serotype specific B-cells, the humoral immune response and safety after sequential vaccination versus simultaneous vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent polysaccharide vaccine (PPV23) versus single vaccination with PPV23 in a prospective, randomized controlled monocentric head-to head clinical study in elderly. The hypothesis of this study is that simultaneous vaccination with PCV13 and PPV23 might achieve an improved immune-response compared to sequential vaccination or single vaccination.

Adults \>=60 years without previous pneumococcal vaccination will be randomized in three groups and receive either PCV13 on day 0 plus PPV23 6 months later (sequential vaccination) or they receive PCV13 plus PPV23 simultaneous on day 0 (simultaneous vaccination) or they receive PPV23 on day 0 (single vaccination). Blood will be taken for pneumococcal serotype-specific B-memory cells against four vaccine-serotypes (ST), included in PCV13 and PPV23, vaccine-serotype 3 (ST3), vaccine-serotype 14 (ST14), vaccine-serotype 19A (ST19A) and vaccine-serotype 23F (ST23F) at visit 1, 2,4,5,7 and 8 and for antibody levels against the 12 vaccine-serotypes included in PCV13 and PPV23 at visit 1, 3, 4, 6, 7 and 8 in all three groups. Adverse events will be recorded for 28 days after each vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Unvaccinated adults \>= 60 years
* Written informed consent

Exclusion Criteria:

* Hypersensitivity against substances included in both vaccines
* Previous pneumococcal vaccination
* Pneumonia within the last two months
* Active infection
* Autoimmune disease
* Ongoing or planned immunosuppressive therapy (including corticosteroid treatment with prednisolon equivalent dose \>= 5 mg/d)
* Active malignant disease
* Drug abuse or alcoholic abuse
* Expectation of life \< 2 years
* Coagulation disorders
* Burns or injury on the injection site
* Plegia or paresis of extremity where injection is planned
* Shock
* parallel participation in other clinical trial with intervention
* Infusion of blood products within the last half year
A Study on the Safety of Hakim Programmable Shunt System

This study aimed to collect safety information from subjects implanted with a shunt system (trade name: Hakim Shunt Programmable System) produced by Codman \& Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.


Eligibility Criteria:
Inclusion Criteria:

1. The informed consent was exempted by the Ethics Committee of a research center. Either a subject or his/her legal representative signed the informed consent form (ICF) prior to enrollment.
2. Subject had an indication suitable to use Hakim Shunt Programmable System.
3. Subject received a Hakim Shunt Programmable System at least one year ago.

Exclusion Criteria:

1. Subject didn't have an indication suitable to use the product.
2. Subject was known to be allergic to a component or ingredient of the product to be implanted, including silicone tubing and other components.
3. According to the comprehensive judgment of an investigator, subject had an infection of the implant site when the shunt system was implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
4. Subject was simultaneously implanted with another shunt system different from Hakim Shunt Programmable System.
5. Subject had a contraindication of the shunt operation.
6. Subject had uncorrected coagulopathy or any bleeding disorder.