cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of JMT103 in Patients With Giant Cell Tumor of Bone

This is a phase Ib/II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of JMT103 in patients with surgically unsalvageable or refractory giant cell tumor of bone (GCTB).

The objective of the trial is to evaluate the efficacy and safety of JMT103 in patients with GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity.

This study consists of two parts (phase Ib and II). In the phase Ib part, 6 to 12 subjects will be enrolled, and the safety, pharmacokinetics and pharmacodynamics of JMT103 will be evaluated after treatment for more than 4 weeks. And then the phase II part will be conducted, in which, 125 subjects will be enrolled.

Eligible subjects will receive JMT103 at a dose of 2mg/kg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 2mg/kg SC on study days 8 and 15 until disease progression, tumor resection (the pathologic outcome after surgical resection is CR or PR), intolerable toxicity, decision by the participant to discontinue, or decision by the investigator that the subject could no longer benefit from the treatment (whichever occurs first).

Eligibility Criteria:
Inclusion Criteria:

1. Fully informed and signed informed consent.
2. Male or female, Adults, 18 years and older
3. Histologically confirmed GCTB that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Exclusion Criteria:

1. Fertile subjects refuse to use effective contraception methods from the signing of the informed consent to 6 months after the last dose;
2. Active dental or jaw condition which requires oral surgery, including tooth extraction;
3. Currently receiving other anti-tumor therapy (radiotherapy, chemotherapy or arterial embolization, etc.);
4. Concurrent treatment with bisphosphonates;
5. Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ.
Functional Performance and Biopsychosocial Characteristics in Individuals with Systemic Sclerosis

In individuals with systemic sclerosis (SSc), the loss of functionality severely affects quality of life. This condition may cause psychosocial effects by affecting the person, their family, and the environment. Activities of daily living, quality of life, and psychosocial well-being are affected, and aesthetic concerns arise.

Different scales evaluating the quality of life, functions, and disease characteristics of individuals diagnosed with SSc are accepted. In this field, modified Rodnan skin score (mRDS), Duruöz hand index (DHI), scleroderma health assessment questionnaire (SHAQ), and Short Form-36 (SF-36) are frequently used. The BETY-Biopsychosocial Questionnaire is also included in the literature for the evaluation of the biopsychosocial effects of individuals with rheumatism.

In addition, it is essential to evaluate the characteristics of individuals who maintain their health with chronic diseases. Therefore, assessment parameters such as the Chronic Disease Self-Management Scale, Exercise Self-Efficacy Scale, Short Form Illness Perception Scale, Body Awareness Questionnaire, Central Sensitisation Scale, and Tampa Kinesiophobia Questionnaire are frequently used in this regard. The 6 Minute Walk Test (6 MWT) is recommended as a frequently used method to determine cardiopulmonary endurance in individuals with SSc.

It is known that there is a decrease in the distance walked in this test compared to healthy individuals, and the fall potential of physical performance is an important parameter.

In addition, there are also methods used to evaluate physical performance, such as the five-repetition sit-and-stand test (CST), the Stair Climbing Test (SCT), and the Timed up-and-go test (TUG). Considering all these effects, there is a need to examine the relationship between functional and biopsychosocial impact in individuals with SSc.

This study aims to examine the relationship between functional performance and biopsychosocial characteristics in individuals diagnosed with systemic sclerosis and to present the results for this disease group.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Systemic Sclerosis
* To be between 18-65 years old
* Being reader literate

Exclusion Criteria:

* Having a severe musculoskeletal disability
* Being diagnosed with pulmonary hypertension
* History of active infection
* Having a severe neuropsychiatric disorder
* Pregnancy
EEG-based Personalized Transcranial Magnetic Stimulation (eTMS) to Treat Post-Traumatic Stress Disorder

This is a randomized, sham controlled study of the Electroencephalogram (EEG) based Transcranial Magnetic Stimulation (eTMS) treatment for Post-Traumatic Stress Disorder (PTSD). The recruitment goal is 110 participants who are United States Military veterans or first responders (e.g., firefighters, police, paramedics, etc.). The Study includes an EEG recording in order to determine the optimal treatment parameters for the eTMS system, followed by 15 in-office visits that take place over 21-28 total days. Two eTMS treatment sessions are administered during each office visit.

eTMS-PTSD-001 Stage 2 is a randomized, sham controlled study with a recruitment goal of 100 subjects, with 99 completers. The Study is intended to evaluate the safety and efficacy of eTMS in the target population. A maximum of 800 individuals will be screened in order to achieve the recruitment goal. The total number of days from the first participant enrolled to the last enrolled participant treated will be approximately 10 months.

Participants will be either Veterans or First Responders (e.g., emergency medical service provider, firefighter, or any other emergency response personnel), between 22-65 years of age. Participants may be male or female of any racial/ethnic background who meet the eligibility criteria. Participants will be recruited from the general public, and from veterans and first responder organizations.

The primary outcome for the Study will be reduction in PTSD symptoms as calculated by the PTSD Checklist for DSM-5 (PCL-5) assessment.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to consent to participate in the study via signed Informed Consent
* Age 22 - 65 years
* Diagnosis of PTSD according to DSM-5 criteria via the Clinician-Administered PTSD Scale (CAPS).
* Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms persisting for a minimum of 6 months prior to the Screening Visit
* Veterans Administration PCL-5 cut point score of 31 or above
* Positive identification as either a Veteran, or First Responder (e.g., emergency medical service provider, firefighter, or any other emergency response personnel)

Exclusion Criteria:

* Uncontrolled medical, psychological or neurological condition
* Pregnant, or female unwilling to use effective birth control during the course of the trial
* Metal objects in the head
* Past exposure to metal fragments, permanent piercings, and/or other possible metal sources in the head and neck
* Current participation in any interventional research protocol
* History of any type of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)
* History of stroke or intracranial lesion or increased intracranial pressure
* History of epilepsy of seizure
* Family history of epilepsy or seizure in 1st degree relative
* An elevated risk of suicide or violence to others
Professional Consequences of Ocular Trauma Hospitalized at the Hospital Centre of Clermont-Ferrand

Ocular trauma are a real public health issue. According to WHO, it is estimates at 750,000 hospital admissions per year in the world for ocular trauma, including 200,000 for open globe injuries in the world. Consequences can be severe with a significant number of definitive low vision or blindness which can lead to professionnal reclassifications for active patients. However, no study exists on professional consequences of those ocular trauma. Some studies showed that fonctionnal loss of an eye can also have psychological consequences such as post traumatic depression or can impair the quality of life but studies are scarce on this subject.

The primary objective is to study the professional reclassification of workers at least 6 months after their hospitalization for ocular trauma.

Secondary objectives are to assess, at least 6 months after an hospitalized ocular trauma, characteristics of eye injuries, characteristics of patients, mid-term consequences at work after eye injury and on personal aspects.

Use of the ophthalmologic consultation report, the ophthalmologic hospitalization report and a telephone questionnaire to carry out the study.

At least 6 months after the traumatism, an ophthalmologist member of the team, M. Vincent Jawad, will call each patient for answering a telephone questionnaire after obtention of his oral consent.

If the traumatism occur after the beginning of the study, the patient will be informed, by M. Vincent Jawad, of the modalities of the study during his hospitalization and an information letter will be given to the patient in the same time (annex 2). His non opposition will be asked by telephone, remote from the hospitalization, before proceeding to the telephone questionnaire.

If the traumatism occur before the beginning of the study or if the information and non opposition letter has not been given to the patient during the hospitalization, the information letter (annex 2) will be sent by mail to the patient before the telephone call.

In all cases, the patient's consent (or non opposition) will be collected orally before proceeding to the telephone questionnaire (annex 1).

Medical data will be obtained from the medical report of hospitalization and the last report consultation of his ophthalmologist.

Eligibility Criteria:
Inclusion Criteria:

* Adults, with a job
* hospitalized for ocular trauma in the ophthalmology unit of the University Hospital of Clermont-ferrand
* from january the first of 2005 to december the 31st of 2022.

Exclusion Criteria:

* Patient without job at the time of the ocular traumatism
* Refusal to participate in the study
* Unable to answer to the telephone questionnaire (difficulties understanding, cognitive disorders...)
* Impossibility to contact the patient
Microperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy

A half-dose photodynamic therapy, a relative new treatment, has been widely performed to treat central serous chorioretinopathy.

The researchers aimed to investigate whether the therapy improved the patient's visual acuity as well as the retinal sensitivity. The researchers also investigate which clinical factors, if any, were associated with the results; visual acuity or retinal sensitivity after the treatment.

The best-corrected visual acuity (BCVA), macular sensitivity, and fixation stability were evaluated at the baseline and at 1, 3, 6, and 12 months after the half-dose photodynamic therapy. The macular sensitivity and fixation stability were determined by MP-1 microperimetry (Nidek, Vigonza, Italy). The researchers analysed whether the BCVA and retinal sensitivity significantly improved or not. And if yes, the researchers were interested at which period after treatment the significant improvement was found. Also, the researchers investigated which improved first, BCVA or retinal sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* the presence of subretinal fluid involving the fovea in the Optical coherence tomographic (OCT) images
* a serous retinal detachment of at least 6 months duration.

Exclusion Criteria:

* evidence of a choroidal neovascularization (CNV), polypoidal choroidal vasculopathy, or other maculopathy documented by fluorescein angiography or Indocyanine green angiography
The Expression of Antigens in Bone Marrow Samples From Volunteering Donors.

Antigen expression levels in bone marrow from volunteering donors will be analyzed. The results of this analysis will be used to establish a clinical test to identify cancer patients who could qualify to receive an investigational treatment being developed by GlaxoSmithKline.


Eligibility Criteria:
Inclusion Criteria:

* The donor is aged \>= 18 years
* Written informed consent has been obtained prior to the performance of any specific procedure.
* The donor has a medical indication for which a bone marrow aspiration is planned.
* The donor is eligible for a bone marrow aspiration.
Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy

The investigators aim to investigate the differences between deep continuous muscle relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in respect to metabolic changes and respiratory mechanics.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years
* undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* previous surgeries,
* a history of venous or arterial diseases,
* BMI (≥30 kg/m2),
* Allergy to rocuronium.
* Significant liver dysfunction.
* Significant renal dysfunction (S-creatinine \> 200 umol/l).
* Neuromuscular disease that might impair neuromuscular blockade
* Pregnant or breastfeeding.
* Indication for rapid sequence induction.
* Inability to informed consent
Combined Social Worker and Pharmacist Transitional Care Program

In an effort to improve care coordination and reduce hospital readmissions, Rush University Medical Center developed the Combined Social Worker and Pharmacist Program, which targets both the psychosocial and clinical risk factors that can lead to rehospitalization. This study will evaluate the impact of this program on 30-day same hospital readmission rates and total cost of care.

If a patient is enrolled in the Combined Social Worker and Pharmacist Program their care will differ from usual care in a number of different ways. First, while the patient is in the hospital, an interdisciplinary group of providers will round on the patient on a regular basis. This interdisciplinary team will be composed of an attending physician, clinical pharmacist, nurse, case manager, and social worker, who will all evaluate the patient's needs from a variety of perspectives to ensure that the patient is prepared for discharge and self-manage post-discharge. During the patient's hospital stay, a clinical pharmacist will also conduct a detailed medication reconciliation of home medications, assess medication-related risks, and provide relevant education to patients participating in the program. After the patient is discharged from Rush University Medical Center, a Master's prepared social worker will then contact the patient and conduct an assessment from a psychosocial perspective to identify any unmet needs. Lastly, a clinical pharmacist will be available to patients enrolled in the Combined Social Worker and Pharmacist Program, should they have any medication-related questions post-discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Planned discharge to home or home health
* English-speaking
* At least one of the following risk factors:
* Use of high risk medication(s): Anti-coagulant therapy, dual ASA/plavix therapy, anticholinergic agent, digoxin, opioids, psychotropic medications, or erythrocyte stimulating factor
* Clinical risk factor: Depression, fall risk, limited functional capacity, substance abuse, dementia
* Psycho-social risk factor: high care giver burden, family conflict, limited health literacy, lives alone, significant patient stress, transportation concerns, health care scheduling concerns, inadequate emotional support.

Exclusion Criteria:

* Hospice
* Solid organ transplant
* End-stage renal disease
* Current chemotherapy or radiation therapy
Effect of Using Dextrose-containing Intraoperative Fluid in Children

The glucose-containing fluid was preferred for maintenance fluid in pediatric surgery to prevent hypoglycemic events. This practice can lead to intraoperative hyperglycemia which can induce osmotic diuresis and consequently dehydration and electrolyte disturbances.

As an anesthesiologist, the use of glucose-containing fluid should be reconsidered to avoid these undesirable effects in pediatric surgery.

Our study aims to identify an appropriate use of 5% dextrose containing solution during intraoperative period in children (2 age groups: 1-2 vs 3-5 years old) that can prevent glucose and lipid mobilization without causing hypo/hyperglycemia and provide adequate fluid maintenance in the context of hospitals in Thailand

* In this randomized controlled trial, the investigator will find the difference in pre and postoperative value of base excess among the different fluid groups which is an acid-base parameter indicating volume status and mobilization of lipid stores in each age group (2 age group: 1-2 vs 3-5 years old). Each age group will be divided to:

  1. Group D0: patients will receive Acetate Ringer's solution (Acetar) infused at maintenance rate
  2. Group D1: 5%dextrose in normal saline (5%DNSS) infused ¼ of maintenance rate \[resulted in 1.25%dextrose equivalence\]
  3. Group D2: 5%DNSS infused ½ of maintenance rate \[resulted in 2.5%dextrose equivalence\]
  4. Group D5: 5%DNSS infused with maintenance rate
* Patient will be fasting as standard preoperative fasting protocol, and received 5 ml/kg of water at 3 hours prior to surgery
* After standard anesthesia induction and intravenous line (IV) placement, the blood samples will be collected and the POCT glucose will be re-evaluated every 1 hour through the operation to avoid intraoperative hypo/hyperglycemia.
* The first blood sample will be collected after IV line placement and the second blood sample will be collected at the end of surgery. Both blood samples will be sent to the lab to measure blood glucose, serum electrolytes (sodium, potassium, and chloride), acid-base parameters (pH, base excess, standardized bicarbonate, anion gap), endocrine parameters (serum insulin, glucagon, cortisol), and metabolic parameters (free fatty acid, serum ketone, serum lactate).

Eligibility Criteria:
Inclusion Criteria:

1. Children aged of 1 to 5 years
2. ASA physical status 1 and 2
3. Schedule for elective non-abdominal surgery between 1-3 hours under general anesthesia without anticipation of major blood loss at Siriraj Hospital.

Exclusion Criteria:

1. Patients with severe neurologic, cardiac, endocrine, or metabolic disease
2. Patients receiving intravenous fluid preoperatively
3. Patients with history or have known risk of hypoglycemia
4. Patient with severe liver dysfunction

Withdrawal or termination criteria

1. Patients requiring intraoperative blood product transfusion or inotropes infusion
2. Patients who have preoperative hypoglycemia
Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With OSA

The purpose of this study is to assess the effects of physical exercise, associated or not with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper airway resistance in obese teenagers. Half of the participants will undergo physical exercise and compression socks program, and the other half of subjects will undergo physical exercise program without compression socks.

Obesity is an important factor of OSA development in children and teenagers, and physical activity is a relevant alternative to promote OSA decrease with ou without weight loss.

Physical activity, beyond the improvement of body composition and exercise cardiorespiratory capacity, restricts fluid retaining in the lower limb of the leg by the activation of musculovenous pump. Fluid retaining is involved in OSA severity because of nocturnal fluid shift from legs to rostral zone which promotes pharyngeal oedema development and upper airway collapsibility.

It has been previously shown that venous compression leads to beneficial fluid regulation in OSA subjects and appears as an efficient tool in OSA management.

To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA.

Eligibility Criteria:
Inclusion Criteria:

* Obese adolescents (BMI \> 97th percentile),
* patients aged from 12 to 17 years old, (born between 07/01/2003 and 09/01/1197),
* enrolled in a pediatric obesity center with diet and physical activity programs and psychological management,
* without observed tonsils hypertrophy (Mallampati and Friedman scores),
* without contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography,
* with physical activity certificate issued by a cardiologist
* covered by the national insurance scheme of his/her legal representative,
* having signed, as well as his(her) legal representative, the informed consent of participation.

Exclusion Criteria:

* Non obese adolescents (BMI \< 97th percentile)
* patients aged under 12 or over 17 years old,
* not enrolled in a pediatric obesity center with diet and physical activity programs and psychological management,
* with observed tonsils hypertrophy (Mallampati and Friedman scores),
* with contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography,
* without physical activity certificate issued by a cardiologist
* uncovered by the national insurance scheme of his/her legal representative,
* not having signed, as well as his(her) legal representative, the informed consent of participation.
Nabothian Cyst Protects or Facilitates Against Cervical Cancer

Aim of the study to asses the realition between HPV infection, Nabothian Cyst and Cervical Intraepithelial lesions or Cervical Cancer

Nabothian cysts are one of the common gynecological pathologies. They rarely have clinical significance. Transvaginal ultrasonography and magnetic resonance imaging are the most useful imaging methods for cervical cystic lesions.HPV infection is the most important factor which can cause cervical malignancy and premalignant lesions. In women between 30-65 years of age HPV-DNA testing, is used as a screening test in Turkey. In this research, the aim is to examine whether there is a connection between Naboth cysts and HPV infection in the cervix. During the examination, the swab sample required for HPV PCR testing will be taken. The number and size of Naboth cysts with vaginal USG will be noted. If the patient had colposcopy / LEEP (Loop Electrosurgical Excision Procedure), the result will be investigated and noted.

Eligibility Criteria:
Inclusion Criteria:

To have Naboth cyst and/or HPV positivity Must be willing and able to provide informed consent Comply with the study protocol Between 25-65 age range

Exclusion Criteria:

To Refuse participate in our research The age under 25 and over 65 Ovarian, endometrial and vulvar malignancies Without both Naboth's cyst and HPV positivity To have LEEP/Cervical Conization before History of Cervical Dysplasia