cyrilzakka/clinical-trials huggingface dataset:
Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.

This study is a long-term follow-up of postoperative clinical outcomes in patients with lumbar spine disorders, monitoring spine implants SmartMIS Spinal Fixation System and ASA Spinal Fixation System.

Patients will be selected based on inclusion and exclusion criteria. The informed consent process will be initiated by the physician. A questionnaire-based survey will be conducted, which includes the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Fusion Rate. Subjects will complete the same questionnaire assessments preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.

The total number of subjects to be enrolled is 120. The total duration of the study is expected to be 4 years.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 20 and 80 years.
2. Patients with lumbar spine disorders requiring surgical treatment.
3. Able to understand the study content after explanation, capable of expressing their experiences, and willing to sign the written informed consent form.

Exclusion Criteria:

1. Individuals with impaired decision-making capacity or from vulnerable populations.
2. Individuals who are unable or unwilling to return for follow-up assessments.
Povidone-Iodine Oral Rinse Study

This study is a two-arm, randomized, 2-phase study. Phase I will be double blinded clinical trial of the safety and efficacy of an antiseptic mouthwash solution on reducing SARS-CoV-2 load in COVID 19+ adult individuals. Phase II is designed as an open label trial, and all subjects will receive the active mouthwash.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide informed consent prior to initiation of study procedures.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 18 years and older.
4. Clinical diagnosis of COVID-19 infection confirmed with a positive point of care test.
5. Confirmed diagnosis within 5 days of baseline visit (within 5 days of COVID-19 test) and at least one clinical COVID-19 symptom \[\*Signs and symptoms of COVID-19 present at illness onset vary, but over the course of the disease, most people will experience the following: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste of smell, sore throat, congestion or runny nose, nausea or vomiting and diarrhea.\]
6. Presents with a minimum of six natural teeth.
7. Ability to rinse/gargle with study products.
8. Not using mouth rinse/gargling solutions at the time of enrollment.
9. Not taking antimicrobial medications (antibacterial, antiviral, antibiotics, including hydroxychloroquine) at time of enrollment.
10. Ability to participate in the study and come to site during Phase I of the study for collection of swabs and saliva.
11. Willing to use an acceptable method of birth control throughout duration of the study. Acceptable methods include hormonal contraceptives, barrier methods, abstinence, or other effective methods approved by the PI.
12. If continuing to Phase II of the trial, ability to continue using study products for 1 week (+ 3 days). (Participants do not have to agree to participate in Phase II in order to participate in Phase I.)
13. If continuing to Phase II of the trial, agree to receive text messages/phone calls containing questionnaires regarding compliance and use of study product, and reminders, able to complete virtual follow-up study visit for collection of outcomes data.

Exclusion Criteria:

1. Individuals receiving antiviral medications
2. Pregnant or breastfeeding women (for premenopausal women of childbearing potential, pregnancy status to be confirmed through a urine pregnancy test during the study visit)
3. Inability to comply with study protocol
4. Having an allergy to any of the study mouthwash ingredients
5. Having any thyroid condition.
6. Presents with a current suspicious oral lesion at the examiner's discretion, and/or currently undergoing radiation therapy for head or neck cancer, and/or has received radiation therapy to the head or neck (including radioactive iodine therapy).
Study of Efficacy and Safety of LJM716 and Cetuximab in Head and Neck Squamous Cell Carcinoma Patients

To establish whether LJM716 in combination with cetuximab is safe and has beneficial effects in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Most recent regimen contains both platinum and cetuximab (Phase II, group B).
* ECOG Performance Status (PS) ≤ 2.
* Recovery from all AEs of previous anti-cancer therapies, to baseline or to CTCAE Grade ≤ 1, except for alopecia.
* Measurable disease as determined by RECIST v1.1.

Exclusion Criteria:

* Previous anti-HER3 antibody treatment.
* Symptomatic brain metastasis.
* Prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment.
* Prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.
* Inadequate end organ function.
* Ongoing diarrhea CTCAE Grade ≥ 2. Other protocol-defined inclusion/exclusion criteria may apply
Artelon Metatarsophalangeal (MTP) Spacer

The aim of this prospective, case series is to evaluate the surgical treatment of painful and disabling osteoarthrosis in the MTP-I joint by insertion of an Artelon MTP Spacer.


Eligibility Criteria:
Inclusion Criteria:

* The patient experiences pain and limitations of the great toe dorsiflexion at the MTP-I joint.
* The patient has a clinically and radiographically verified arthritis in the MTP-I joint indicating the need for surgical treatment.
* The patient reads, understands and is able to complete the study questionnaires in Swedish.
* The patient has received written and oral information regarding the study and has signed the informed consent form.

Exclusion criteria:

* The patient has a pronounced hallux rigidus without mobility in the MTP-I joint (ROM = 0°).
* The patient has previously received surgical treatment affecting the anatomy of the MTP-I joint.
* The patient has a systemic rheumatic disease, ongoing infection, hallux valgus or is seriously ill.
Metabolic Safety of Raltegravir Versus Darunavir in HIV Naive Patients

The advent of new antiretroviral drugs improved the management of HIV naive patients in terms of efficacy. However, the long term metabolic profile of this drugs has not yet been compared and associations between new antiretrovirals and cardiovascular events remains controversial.

Moreover, the better tolerability and easy dosage of this new drugs might hypothetically influence adherence and QOL of HIV patients.


Eligibility Criteria:
Inclusion Criteria:

* VIH-1

Exclusion Criteria:

* pregnancy
* previous Antiretroviral exposure
Effect of Heart Rate on Left Ventricular Performance

The current study is aimed at determining the normal response to increasing heart rates. For this purpose, atrial pacing will be used to increase heart rate.

Participants will be patients with pacemakers and normal A-V node conduction with a possibility for right atrial pacing mode.

Detailed Echo studies will be performed at baseline. Echo studies will be repeated at each pacing stage, stages defined as 10 bpm increments in paced heart rate. Each stage will last 2-3 min or as long as it takes to record the echo study. Heart rate will be increased to 85% of predicted heart rate for age or at to appearance of signs of ischemia.

Hemodynamic parameters will be recorded and segmental longitudinal strain will be calculated (as well as other Echo data), for each stage.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with AAI or DDD pacemaker with intact AV nodal conduction that can be set to work in AAI mode.
2. Stable rhythm (either sinus or paced).
3. Good quality baseline echo.
4. Able and willing to sign Informed Consent Form.

Exclusion Criteria:

1. Prior heart failure or ischemic heart disease.
2. Severe valvular lesions.
3. Severe pulmonary hypertension.
4. Known intolerance to rapid pacing.
5. Multiple extrasystoles (more than 1 per echo or monitor screen).
6. Age over 70.
A Positron Emission Tomography Study of SLV354 in Healthy Subjects and Subjects With Schizophrenia

This open-label, Phase 1 study will investigate the 5-hydroxytryptamine 6 (5-HT6) receptor occupancy in the brain using positron emission tomography (PET) following single oral doses of SLV354. Up to 22 healthy male subjects and male subjects with stable schizophrenia, between 18-55 years of age are to complete the study.

This is an exploratory, open-label PET study designed to examine the relationship between SLV354 plasma concentration and 5-HT6 receptor occupancy in the brain following single oral doses of SLV354 in healthy male subjects and male subjects with stable schizophrenia. A total of up to 22 subjects are to complete the study, including approximately 12 subjects with schizophrenia on a stable dose of an atypical antipsychotic medication. Within 60 days prior to the PET scan, subjects will be screened based on medical history, physical examination, vital signs, ECG, clinical laboratory tests, response to Columbia-Suicide-Severity Rating Scale (C-SSRS) and for schizophrenia subjects only, the diagnosis of schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR). Following Screening, eligible subjects will have a Magnetic Resonance Imaging (MRI) scan, unless one was performed within one year of the PET scan, to delineate the region of interest for the individual PET images. The radiotracer \[11C\]-QUICS will be used for the PET scans.

All subjects will receive a single oral dose of SLV354. Healthy subjects will have one PET scan prior to and two PET scans after administration of SLV354. Schizophrenia subjects will have two PET scans prior to and one PET scan after administration of SLV354.

Eligibility Criteria:
Inclusion Criteria

1. Male, age between 18 and 55 years, inclusive.
2. Body Mass Index 18 to 30 (healthy) and 18 to 38 (schizophrenia).
3. A condition of general good physical health.
4. Schizophrenia subjects must have a diagnosis of schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR).
5. Schizophrenia subjects must be on a stable dose of an atypical antipsychotic for at least 4 weeks prior to Screening.

Exclusion Criteria

1. Presence of a metal implant that would preclude a Magnetic Resonance Imaging (MRI) scan.
2. Radiation exposure for research purposes within the past year that will exclude participation in the study.
3. Significant current suicidal ideation within the past month as evidenced by Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening.
4. History of psychiatric diseases or disorders (healthy subjects)
5. Unsuitable to receive SLV354 or the radiotracer, \[11C\]-QUICS.
Study of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects

A Dose Escalating Study of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects

PRS-060 is a new drug being developed for treatment of asthma. The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single ascending doses of PRS-060 in healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female of non-childbearing potential (post-menopausal or surgically sterilized) subjects of 18 to 55 years of age
* Body mass index (BMI) of 18-35
* Subjects who are non-smokers or ex-smokers who have not smoked in the last 6 months (determined by urine cotinine \< 500 ng/ml, at screening visit).

Exclusion Criteria:

* History or clinical manifestations of any clinically significant medical disorder that, in the opinion of the investigator, may put the subject at risk because of participation in the study, influence the results of the study or affect the subject's ability to participate in the study.
* A history of drug or alcohol abuse.
* History of, or known significant infection including hepatitis A, B, or C, Human immunodeficiency Virus (HIV), tuberculosis (i.e., positive result for Interferon (INF)-y release assay (IGRA), QuantiFERON TB-Gold), that may put the subject at risk during participation in the study.
* Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of day 1 or planned inpatient surgery or hospitalization during the study period.
* Subjects with any history of malignancy or neoplastic disease.
* Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the principal investigator.
* Subjects who have received live or attenuated vaccine in the 4 weeks prior to day 1 subjects with a disease history suggesting abnormal immune function
* Inability to communicate well with the Investigator (i.e. language problem, poor mental development or impaired cerebral function)
* Participation in any clinical study for a New Chemical Entity within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks or within 5 half- lives, whichever is the longer, before the first dose of study drug.
* Donation of 450 ml or more blood within the previous 12 weeks
* Women who are pregnant
* Males who are sexually active with a female partner of childbearing potential and who have not had a vasectomy and who do not agree to double methods of contraception with at least one barrier from day 1 for 90 days.
Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes

The objective of this study is to assess the safety and efficacy of islet allotransplantation for the reestablishment of stable glycemic control in patients with type 1 diabetes, using anti-thymocyte globulin induction immunosuppression with sirolimus, mycophenolate mofetil and low dose tacrolimus maintenance immunosuppression.

To assess the safety and efficacy of a new single-donor islet allotransplant protocol focusing on minimization of ischemic damage by the two-layer pancreas preservation technique, attenuation of posttransplant nonspecific inflammatory responses by etanercept and anti-thymocyte globulin, deletion/inactivation of autoreactive T cells by anti-thymocyte globulin and daclizumab induction immunotherapy, and potent yet non-diabetogenic maintenance immunosuppression with sirolimus and delayed mycophenolate mofetil instead of tacrolimus for the reestablishment of stable glycemic control in recipients with type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Primary islet allotransplant
2. Type 1 diabetes mellitus, complicated by at least one of the following situations that persist despite intensive efforts in close cooperation with their diabetes care team:

   1. Metabolic lability/instability;
   2. Reduced awareness of hypoglycemia;
   3. Persistently poor glucose control (as defined by HgbA1c\>10% at the end of six months of intensive management efforts with the diabetes care team);
   4. Progressive secondary complications.
3. Age 18 and older
4. Able to give written informed consent

Exclusion Criteria:

1. Known hypersensitivity to rabbit proteins.
2. Presence of history of panel-reactive anti-HLA antibodies (\>10%).
3. Insufficient cardiovascular reserve.
4. Creatinine clearance \<60 mL/min/m2.
5. Portal hypertension, abnormal liver enzyme tests, or history of significant liver disease.
6. History of malignancy within 5 years.
7. Active peptic ulcer disease.
8. Severe unremitting diarrhea or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications.
9. Pregnancy or breast-feeding.
10. Active infections.
11. Serological evidence of infection with HIV, or HBsAg or HCVAb positive within the previous 12 months prior to transplantation.
12. Negative screen for Epstein-Barr Virus (EBV) by an EBNA method
13. Evidence of infiltrate, cavitation, or consolidation on chest x-ray during pre-study screening.
14. Schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medications.
15. Ongoing substance abuse; drug or alcohol.
16. Recent history of noncompliance.
17. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients

This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.


Eligibility Criteria:
Inclusion Criteria:

* Who are able and willing to give signed informed consent
* Who are male or females aged between 18 and 65 years with plaque psoriasis confirmed by the Investigator.
* Who have less than 20% of body surface area (BSA) afflicted with plaques
* Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criteria:

* Who have a history of allergy to vitamin D3 derivative preparations.
* Who have a history of relevant drug hypersensitivity.
* Who have a history of contact dermatitis induced by a topical medicine.
* Who are pregnant or lactating.
* Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
* Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
* Whose serum calcium levels exceed the upper limit of reference range
* Who have used any investigational medicinal product and/or participated in any clinical study within 24 weeks
* Who have been treated with systemic therapy within 8 weeks
* Who have been treated with biologics within 12 weeks
* Who have been treated with topical therapy during the wash-out and lead-in period.
Study on Data Acquisition and Image Characteristics of Brain Multifrequency EIT in Healthy People and Patients With Brain Diseases

The goal of this observational study is to compare the differences in the features of cerebral multifrequency EIT(cMFEIT) images between healthy subjects and patients with brain diseases and to explore the possibility of applying multifrequency EIT to intracranial abnormality detection.16 healthy volunteers and 8 patients with brain diseases were recruited as experimental subjects, and the cerebral EIT data of 9 frequencies in the range of 21 kHz - 100 kHz of all subjects were acquired with an EH-300 MFEIT system.

For subjects who received clinical trials, 16 electrodes were placed equidistantly in their head, and brain EIT data were measured at 9 frequencies in the range of 21 kHz to 100 kHz by applying a current RMS of 176 microamps. The healthy group included 16 individuals (male, age 40.25±11.18). No history of brain disease and no abnormalities were seen on plain CT scans of their brains. Cerebral EIT data collection from healthy volunteers was performed in a dedicated laboratory with temperature controlled at 24±1 °C and 52%±1% humidity in 2022. The subjects were lying in a horizontal position. The patient group included 8 patients with brain diseases (7 males, age 59±10.46). Obvious lesions were visible on the patients' CT or MRI images, including 6 patients with intracranial hemorrhage, 1 patient with cerebral ischemia, and 1 patient with cerebral edema. Data from patients with brain diseases were collected at the neurosurgical intensive care unit at the Army Medical Center of PLA in 2022. The cerebral EIT data of the patients were collected in the same position as the healthy individuals. The MFEIT image sequence is obtained according to a certain imaging algorithm, and the ROI area ratio (AR_ROI) on the left and right sides of the image and the average value of the reconstructed ROI resistivity change (MVRRC_ROI) are extracted. Based on the extracted indicators, the geometric asymmetry index (GAI) and intensity asymmetry index (IAI) was further proposed to characterize the symmetry of MFEIT images, and the differences between the two groups of subjects on MFEIT images were statistically compared and analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Health Group: No history of brain disease and no abnormalities were seen on plain CT scans of their brains.
2. Patient Group: Patients with cerebral hemorrhage, cerebral ischemia, and cerebral edema, less than 12 days after onset.

Exclusion Criteria:

1. Health Group:

   * Neurological diseases such as epilepsy, brain tumors, and cerebral vascular malformations;
   * Neurological symptoms such as headache and dizziness;
   * Abnormal signals detected on CT.
2. Patient Group:

   * With other brain diseases without cerebral hemorrhage, cerebral ischemia, or brain edema;
   * With open craniocerebral injury;
   * With severe agitation.
A Prospective Study on the Prediction Model of Para-aortic Lymph Node Metastasis

The goal of this prospective single-arm trial is to investigate the accuracy and feasibility of the para-aortic lymph node metastasis prediction model in locally advanced cervical cancer, as well as its impact on patients' prognosis. The main questions it aims to answer are:

* Is the para-aortic lymph node metastasis prediction model accurate and feasible?
* Whether the para-aortic lymph node metastasis prediction model can affect the prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

* In 2018, the International Federation of Obstetrics and Gynecology (FIGO) stage was Ib3 IIA2-IVA;
* It was treated initially without surgical and chemotherapy.
* Squamous cell carcinoma, adenocarcinoma and adeno-squamous cell carcinoma were confirmed by histopathology.
* Pelvic MRI ± abdominal CT or MRI or PET/CT were performed before treatment.
* ECOG score:0 \~ 1.
* The expected survival time\>6 months;
* There is no absolute contraindication of surgery and and chemoradiotherapy and the patients with good compliance.

Exclusion Criteria:

* History of immune disease who need to take immunosuppressive drugs.
* History of serious mental illness and brain functional disorder.
* Other malignancies were diagnosed within five years or needed treatments.
* Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements.
* Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians.
* Patients who cannot understand the research regimen and refuse to sign the informed consent form.
* Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
Dynamic Plantar Pressures Changes After Dry Needling in Flexor Digitorum Brevis Versus Non Emission Laser

Thirty-six subjects randomly distributed between a dry needling intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. The measurements will be made on a pressure platform to record the dynamic footprint variables.

Thirty-six subjects randomly distributed between a dry needling intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. The measurements will be made on a pressure platform to record the dynamic footprint variables of the first step of both feet.

Eligibility Criteria:
Inclusion Criteria:

* Individuals must have latent trigger point in Flexor Brevis Digitorum muscles with no other pathologies

Exclusion Criteria:

* Previous lower extremities surgery.
* History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.
* Leg-length discrepancy more than 1 cm
* Balance deficits (determined by oral questionnaire regarding falls)