cyrilzakka/clinical-trials huggingface dataset:
A Phase Ib Study of TQB2450 Combined With Anlotinib in Patients With Limited Stage Small Cell Lung Cancer After First-line Radiotherapy and Chemotherapy

To assess the efficacy and safety of TQB2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who do not progress after first-line chemoradiotherapy. Based on the incidence and severity of benign and serious adverse events, as well as abnormal laboratory


Eligibility Criteria:
Inclusion Criteria:

* The subject voluntarily joins the study, signs the informed consent form, and has good compliance;
* Age: 18\~75 years old (when signing the informed consent form); ECOG PS score: 0-1 points; Expected survival beyond 6 months; body weight\> 40 kg;
* Patients with pathologically confirmed limited-stage small cell lung cancer (according to the Veterans Administration Lung Study Group (VALG stage);
* Through the neck, chest, abdomen, pelvic enhanced CT and brain plain scan + enhanced MRI examination with diagnostic quality, there is no evidence of metastatic disease (PET-CT examination is recommended before starting radiotherapy and chemotherapy, if not performed before radiotherapy and chemotherapy PET-CT examination, bone scan examination should be performed; PET-CT examination must be performed during the screening period after chemoradiotherapy to exclude metastasis);
* It is expected that no tumor resection will be required during the study (patients who are not suitable for surgery or those who are unwilling to undergo surgery are acceptable);
* Radiotherapy technology adopts three-dimensional conformal radiotherapy, conformal intensity-modulated radiotherapy, tomographic radiation therapy and other precision radiotherapy technologies;
* Patients must achieve CR, PR or SD after receiving radical platinum-based CRT and cannot develop disease progression;
* Patients with at least one measurable lesion confirmed according to RECIST 1.1 criteria prior to chemoradiotherapy;

Exclusion Criteria:

* Complex small cell lung cancer confirmed by histopathology or cytopathology;
* Subjects with known central nervous system metastasis and/or cancerous meningitis;
* Malignant pleural effusion and pericardial effusion;
* Imaging shows that the tumor has invaded important blood vessels, or the researcher has determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;
* Within 2 weeks before the start of the study treatment, he has received the treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the NMPA approved drug manual;
* Patients who have received immunomodulatory drugs within 30 days before starting treatment;
* Previously received anti PD-1, anti PD-L1, or anti PD-L2 drugs or medication targeting another stimulating or co inhibitory T cell receptor;
* Previous use of antivascular survival drugs（ bevacizumab, arotinib, apatinib ,ect);
Ultrasound Study of Entheses and Small Joints of Hands and Feet in Patients With Atypical Form of Psoriasis

Systematic study of the ultrasound infringements of tendons chest expanders of entheses the most involved in spondylarthropathies and small joints of hands and feet in expanding patients of psoriasis to estimate if there is an infra-clinical infringement of the psoriasic rheumatism .


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Atypical psoriasis of the scalp and / or nails and / or psoriasis of folds
* Patient agreeing to participate in the study

Exclusion Criteria:

* Psoriatic arthritis
* Rheumatic pain
* Arthritis
* Joint Trauma in hands, elbows knees, feet
* Current treatment with methotrexate, soriatane, cyclosporine, corticosteroids
* Current treatment with biological therapy (anti-TNF, anti IL 12-23)
* Previous history of rheumatic disease: inflammatory, microcrystalline, osteoarthritis
* Patients in physical or mental incapacity to agree
Safety and Efficacy of Cryoballoon Pulmonary Vein Isolation : a Single Center Registry

The aim of this study was to assess the long-term success rates of pulmonary vein isolation using first and second generation cryoballoons in patients with paroxysmal and persistent atrial fibrillation.

The success of ablation is determined by the absence of recurrence of atrial fibrillation in the short term beyond 3 months, medium and long term on regular clinical follow-up and ECG holters. The patient cohort followed since 2007 allows a very long-term follow-up of patients who have benefited from atrial fibrillation cryoablation.

Isolation of the pulmonary veins by cryoballoon (IVP) has emerged as an alternative to radiofrequency in the treatment of drug resistant atrial fibrillation (AF). (1) The potential benefits of cryoablation include shorter procedure times, decreased fluoroscopy time, shorter hospital duration, a different rate and type of complications compared to radio frequency offers potential benefits, including Including shorter procedure times, a decrease in the length of hospital stay 1 and a reduction in fluoroscopic time. (2) Effectiveness on a one year follow-up in cryoablation for AF is comparable to that of radiofrequency ablation in a prospective, randomized study with a lower major complication rate (3,4). The number of subjects is limited and most retrospective studies on cryoablation have a limited number of patients or an average follow-up not exceeding one year.

Study of the data and results of the procedures of ablation of AF by cryoablation and long-term follow-up of the patients of the CHU of Grenoble.

Regular monocentric cohort study based on collected data To identify the success rate of cryoablation ablation in paroxysmal and persistent AF

Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication for ablation of atrial fibrillation at the CHU of Grenoble since the use of this technique (November 2007) until November 2016:
* Paroxysmal atrial fibrillation resistant to antiarrhythmic treatment.
* Persistent atrial fibrillation.
* Patients ≥18 years
* Patients with discernment who signed consent for information on the ablation procedure before surgery.

Exclusion Criteria:

* patient less than 18 years old
* patient who refused to sign informed consent for the procedure of ablation
Food Intake and Intra-Nasal Insulin for African American Adults (FIINAAL)

The purpose of this research study is to investigate brain insulin's relationship with food intake in African Americans. Facilitating insulin's entrance into the brain through a nasal spray is currently being studied as a way to prevent or treat Alzheimer's disease. However, brain insulin may also have an impact on food intake. This study is designed to help researchers understand how different factors related to Alzheimer's disease (i.e. APOE genotype and cognitive functioning) influence brain insulin's relationship with food intake.

The investigators will utilize a double-blind, placebo-controlled, randomized crossover design comparing a single acute dose of intranasal insulin to a single acute dose of a saline placebo.

The primary aim will consist of exploring the differences in ingestive behaviors constructs (i.e. hunger, satiety, and fullness) and ad libitum lunch caloric intake between acute administration of either a dose of intranasal insulin or saline placebo. The hypothesis is that acute intranasal insulin will result in the consumption of fewer calories, greater feelings of satiety and fullness, and less hunger compared to acute saline. A secondary aim of this investigation will be to analyzing differences in food intake by APOE genotype, adiposity, and AD family history.

Eligibility Criteria:
Inclusion Criteria:

* self-identify as African American
* are aged 45 years to 65 years old
* are willing to provide written informed consent
* speak and read English

Exclusion Criteria:

* diagnosed with type 1 or 2 diabetes
* pregnant or attempting to become pregnant
* have a history of sensitivity to glutaraldehyde
Study to Investigate TIVA With Propofol on Postoperative Pain and Side Effects

Propofol is a commonly used anaesthetic with rapid recovery and less side effects and total intravenous anaesthesia (TIVA) with propofol is a common technique now. The reduction on certain serum pro- inflammatory cytokines may lead to more smooth post- surgical recovery.

Recent case report proved the analgesic effect of propofol infusion. However other animal and clinical studies showed controversial result.

The aim of this retrospective study is to investigate the postoperative analgesic effects and side effects of intraoperative TIVA with propofol in patient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016.

Objectives:

1. To investigate the analgesic effects of propofol.
2. To evaluate the effect of propofol on postoperative adverse events.

Methods:

Retrospective audit.

Data Collection:

1. Demographic data;
2. Types of analgesic techniques;
3. Type of pain relief modalities;
4. Pain score up to 72 hours postoperatively;
5. Postoperative opioid consumption;
6. Incidence of adverse events during APS care;
7. Patients' satisfaction on pain relief.

Eligibility Criteria:
Inclusion Criteria:

* Anaesthetic records and acute pain service records of patient undergone surgery between 2014 to 2016 in Queen Mary Hospital would be retrieved from the computer.

Exclusion Criteria:

* Essential data were missing.
* Patient participating in other research projects.
* Changes in postoperative pain management technique.
* Patients could not be assessed post-operatively for pain (i.e. post-operative IPPV)
The ICALIC 2 International Multicentric Study

Clinicians need to measure energy expenditure (EE) by indirect calorimetry (IC) to optimize nutritional support for a better clinical outcome, especially in patients with chronic conditions or with high risk of under- and over- feeding. However, IC is rarely used in clinical routine because the devices currently on the market are of tedious use, imprecise and expensive. An easy-to-use, accurate and inexpensive IC device (Q-NRG® CE marking n°MED 9811) has been developed to meet specifications made by and for clinicians. The ease of use of this new IC device has been first evaluated in mechanical ventilation mode. This second phase aims at evaluating the ease of use, the stability and the feasibility of the measurements with this new IC device in canopy and face mask modes for spontaneously breathing adult patients.

This study aims at evaluating the ease of use, the stability and the feasibility of EE measurements with the new IC device in spontaneously breathing adult patients with malnutrition, cancer, surgery or haemodialysis, using the canopy and face mask modes.

Patient data will be obtained from the medical records before EE measurement. EE measurement will be performed sequentially with the Q-NRG® and the IC device currently used in each study center. Patient data input, calibration, installation of face mask or canopy hood on the patient, and EE measurement recording will be performed according to the procedure stated in their respective user manual. Time needed to perform EE will be calculated afterwards from the time the IC device is turned on to EE measurement reaches a steady state with a variation ≤10%.

In a subset of 15 subjects, accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® will be assessed by comparison with the reference method consisting in a mass spectrometer.

Eligibility Criteria:
Inclusion Criteria:

All spontaneously breathing adult patients (≥ 18 years) referred to the Nutrition Unit in the context of malnutrition, cancer, surgery or haemodialysis.

Exclusion Criteria:

1. \< 18 years
2. Intolerance or phobia to canopy or face mask
3. Physical agitation or activity (\< 1hr before EE measurement)
4. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model

The purpose of this study is to investigate and determine the time course and distribution on muscle hyperalgesia and muscle pain in a repeated, low dose NGF model. It is hypothesized that low dosages i.m injections of NGF are able to induce mechanical hyperalgesia and muscle soreness in a same manner (effect of duration) as for dosages previously used in NGF studies. Furthermore, it is also speculated if several injections of low dose NGF into the muscle combined are able to course immediate pain sensation and spreading of muscle hypersensitivity.

Effects of pain responses, symptom development and pattern (time course and distribution) following 5 i.m low dose injections of NGF injected into the tibialis anterior muscle will be compared to a high dose i.m injection of NGF injected into the contralateral side in healthy pain-free subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and pain free volunteers

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, mental illnesses, or psychiatric diseases.
* Past history of chronic pain in the musculoskeletal system (muscle, joint, cartilage, connective tissue)
* Participation in other pain trials throughout the study period
* Lack of ability to cooperate
* Taking any analgesic 24 hours before the injections
* Performing any strenuous leg exercise through out the study period causing sore muscles
Adoptive Transfer of pp65-specific T Cells for the Treatment of Refractory Cytomegalovirus (CMV) Infection

To evaluate the safety and efficacy for treatment of persistent CMV infection in hematopoietic cell transplant (HCT) recipients.

HCT recipients who are receiving immunosuppressive agents to control graft versus host diseases (GVHD) are at high risk for serious CMV infection due to CMV reactivation or reinfection during their post-transplant period.

Antiviral agents used to treat CMV infection have well-known side effects such as bone marrow suppression causing cytopenia and renal toxicities. Therefore, patients in a serious condition would have a higher probability of antiviral treatment-related toxicities and also increased possibility for prolonged antiviral treatment, thus development of antiviral resistance and risk of treatment failure.

Allogeneic HCT recipients are typically lack of these CMV-specific T cells during the post-transplant period and their immune function can be further repressed especially when they are on additional immunosuppressive agents to prevent GVHD. Therefore, these patients may benefit from CMV-specific T cell adoptive transfer.

Eligibility Criteria:
Inclusion Criteria:

* Less than 66 years old Allogeneic HCT recipients who received stem cells from related CMV positive serology donors
* AND recipients have persistent CMV infection more than 2 weeks on antiviral treatment

Exclusion Criteria:

* HCT recipients with severe graft versus host disease, grade 3 or more
* OR organ dysfunction (brain, heart, lung, liver, and kidney): altered mentality, extracorporeal membrane oxygenation, mechanical ventilator, increased liver enzymes 5 times above upper normal values, bilirubin level \>3 mg/dL, CrCl \< 30 mL/min
A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers

This is a first in human, double-blind, randomized, placebo-controlled, two-arm crossover study evaluating the safety, tolerability and PD of ascending dose levels of BBI-001 after:

* a single administration in iron deficient male and female participants, and male and female HH patients (Part A),
* two administrations per day in HH patients (Part B). BBI-001 administrations will be accompanied with consumption of a meal enriched with stable iron isotope Fe57, while corresponding placebo dose administrations will be with a meal enriched with stable iron isotope Fe58.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy iron deficient participants or patients with hereditary hemochromatosis

Exclusion Criteria:

* Serious or unstable medical or psychiatric conditions
* Significant medical history
* Current infections
* Receiving iron chelation therapy or treatment other than stable maintenance phlebotomy for the prior 6 months
* Organ damage from iron overload in the view of the PI would prevent successful completion of the protocol
A Post Market Study to Assess the Spinal Modulation Dorsal Root Ganglion Stimulator System in Chronic Post Surgical Pain

20-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical pain


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic post surgical pain for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
6. Subject is able to provide written informed consent
7. Pain medication dosage has been stable for at least 30 days
8. Patient has been included for implantation according to standard criteria from the Dutch Neuromodulation Society

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects with indwelling devices that may pose an increased risk of infection
8. Subjects currently has an active infection
9. Subject has participated in another clinical investigation within 30 days
10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
11. Subject has been diagnosed with cancer in the past 2 years.
12. Patient has no other exclusion criteria according to standard criteria from the Dutch Neuromodulation Society
Effects of a 12-week Strength Training Program in Men With Myotonic Dystrophy Type 1

Eleven men with myotonic dystrophy type 1 (DM1) underwent a 12-week lower-limb strength training program. The training program consisted of 3 series of 6 to 8 maximal repetitions of 5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion. Training sessions were closely supervised and took place twice a week. It is hypothesised that the training program will induce muscular hypertrophy despite the genetic defect. The training program should also have positive effects on function. The participants were evaluated at baseline, week 6, week 12, month 6 and month 9 to see the effects of the training program and if these effects are maintained over time.


Eligibility Criteria:
Inclusion Criteria:

* DM1 diagnosis must be confirmed by genetic analysis;
* Male gender, aged between 30 and 65 years old;
* Be able to walk without assistance;
* Consent of the neurologist must be given to participate in this study;
* Must reside in the Saguenay-Lac-St-Jean region;
* Subjects must be able to give their consent freely and voluntarily.

Exclusion Criteria:

* Patients with any other form of muscular dystrophy are excluded;
* Any contraindication for strenuous exercise or muscle biopsy.
The Effectiveness of Waiting Room Posters for Stroke Education

The purpose of this study is to determine the effectiveness of posters in improving patient awareness and knowledge of the signs and symptoms of stroke. The control group study will be conducted in the first two weeks. Subsequently, the intervention arm will occur in the subsequent two weeks.

Stroke is a major health problem and a known cause of death and disability worldwide. In Malaysia, stroke is known to be top five causes of death and top ten causes of hospitalization Malaysia. Ischemic stroke accounts for more than 95% of all stroke cases (1). A recent study done in Malaysia showed that only 26% of patients with stroke symptoms presented to the hospital within 3 hours. One of the reasons was patients did not perceive the symptoms of stroke as being that of a serious illness (2). One of the modalities to raise awareness of stroke is through an educational poster. Posters in the waiting room can increase awareness of health promotion issues (3). Therefore, by placing poster regarding sign and symptoms of stroke in the waiting room in a government clinic, can increase awareness of early presentation of stroke.

Eligibility Criteria:
Inclusion Criteria:

* Adult age more than 18 years old and above
* Able to understand Malay
* Able to provide informed consent

Exclusion Criteria:

* None
Migraine Induction Properties of PACAP-38 After Eptinezumab in Migraine Without Aura Patients.

To investigate whether administration of calcitonin gene-related peptide (CGRP) binding monoclonal antibodies eptinezumab prevents pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) induced migraine attacks in migraine without aura patients.

The aim of the present study is to investigate whether

- CGRP binding monoclonal antibodies eptinezumab prevents PACAP-38 induced migraine attacks in migraine without aura patients.

Clinical and basic research have established calcitonin gene-related peptide (CGRP) as central molecule in migraine pathophysiology, yet existing CGRP antagonizing therapies such as the CGRP and CGRP receptor binding monoclonal antibodies are only effective in 50-60% of migraine patients. PACAP-38 and CGRP colocalize in the trigeminovascular system, and both activate adenylate cyclase upon receptor binding which causes increased formation of cyclic AMP (cAMP). It is unknown if CGRP and PACAP-38 signaling pathways differ sufficiently for PACAP-38 to be an alternative treatment target to CGRP. Whether administration of CGRP binding monoclonal antibodies eptinezumab prevents PACAP-38 induced migraine attacks in migraine without aura patients is yet to be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sexes.
* 18-60 years.
* 50-100 kg.
* Women of childbearing potential must use adequate contraception
* History of migraine without aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria.
* No migraine preventive treatment.

Exclusion Criteria:

* A history of serious somatic disease
* \> 50 years of age at migraine onset.
* History of any other primary headaches disorder (except ≤ 5 monthly days with tension- type headache).
* Daily intake of any medication except contraceptives
Incidence of Headache and Its Effect on Quality of Life in Geriatric Patients With Chronic Neck Pain

cross sectional study to detect the incidence of headache and its effect on quality of life in geriatric patients with chronic neck pain. Patients will fill out quality of life questionnaire and headache disability index. We will take information from the patients about:

* The frequency of headache occurrence.
* Visual analogue scale of chronic neck pain. Main measures: chronic neck pain will be assessed by visual analogue scale. Patients will fill out quality of life questionnaire and headache disability index.


Eligibility Criteria:
Inclusion Criteria:

- geriatric patient with neck pain from 1moth ago

Exclusion Criteria:

* patient with the following conditions autoimmune disease neurological disease have previous cervical surgery