cyrilzakka/clinical-trials huggingface dataset:
Raclopride-PET/MRT

Cerebral insulin resistance plays an important role in the development of obesity and diabetes mellitus type 2. The aim of this project is to examine the effect of human nasal insulin on the dopaminergic system. Therefore, characteristics of cerebral dopamine receptors before and after administration of nasal insulin vs. placebo shall be analyzed in a randomized way. Moreover, the investigators plan to examine the insulin action on cortical and subcortical activation in humans and the interaction of dopamine metabolism with \[11C\]-Raclopride-PET/MRI. By performing fMRI measurements, insulin sensitivity of the central nervous system can be investigated simultaneously. Recruiting is planed as a two-step process.First 12 normal-weight (BMI 20-25 kg/m²) men should be examined. If first results show a insulin-dependent effect on the availability of dopamine receptors in the human brain, recruitment of 12 overweight men will get started.


Eligibility Criteria:
Inclusion Criteria:

* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
* Intake of any medication
* HbA1C \<6%
* BMI 20-25 kg/m²
* Clinical routine blood parameters within the normal ranges
* All participants must agree to get informed of unexpected detected, clinical relevant findings.

Exclusion Criteria:

* Acute diseases such as infections (e.g.)
* Any relevant cardiovascular disease
* Any surgery within the last three months
* Any neurologic or psychiatric disease
* Known allergies
* Hb \< 13 g/dl
* Presence of any contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc.
* Claustrophobia
Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery

Recent findings have suggested that laparoscopic surgery is safe and effective, as well as laparotomic one, for treating patients with early stage endometrial cancer (ESEC). Moreover, our long-term previous data have shown a trend in vaginal cuff recurrence in subjects who underwent laparoscopic approach to ESEC consisting of extrafascial hysterectomy, bilateral salpingo-oophorectomy, pelvic +/- para-aortic nodes dissections, regardless grading or lymphovascular space invasion.

Based on these considerations, the aim of the current protocol-study will be to compare two different strategies for vaginal cuff recurrences prevention in patients affected by ESEC treated with laparoscopic surgery. In particular, upper vaginectomy followed by observation will be compared to post-operative brachytherapy.

Women with ESEC scheduled for laparoscopic surgery will be enrolled and randomized in three arms \[vaginectomy group (VG), brachytherapy group (BG), and control group (CG)\]. All laparoscopic procedures will consist of total hysterectomy, bilateral salpingo-oophorectomy, peritoneal washing, systematic inspection of peritoneal cavity and biopsy of each suspect lesion, and pelvic (and eventual para-aortic) lymphadenectomy. In VG an upper vaginecomy will be added to standard laparoscopic procedures followed by observation, whereas BG will receive post-operative brachytherapy. CG will be treated with standard protocol for management of ESEC according to National Comprehensive Cancer Network (www.nccn.org).

Safety and efficacy data will be recorded in each group for 24 months of follow-up.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Early stage endometrial cancer

Exclusion Criteria:

* Other pre-malignancies and malignancies
* Major medical conditions
* Psychiatric disorders
* Current or past history of acute or chronic physical illness
* Premenstrual syndrome (PMS)
* Current or past (within 6 months from study enrolment) use of drugs influencing cognition, vigilance, and/or mood.
To Evaluate the Efficacy and Safety of Gefitinib in Adjuvant Chemotherapy for Lung Adenocarcinoma

The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients.

The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients. The purpose is to explore the role of TKI in neoadjuvant therapy, and to further improve disease-free survival (DFS) and pathologic complete remission (pCR) in EGFR-mutant populations; and reduce surgical complications and mortality.

OBJECTIVES: To evaluate the efficacy of oral gefitinib versus neoadjuvant vinorelbine and carboplatin in operable stage II-IIIA EGFR-mutant non-squamous NSCLC patients, with a 2-year disease-free survival rate. 2yDFS).

Secondary objective: To evaluate pCR, 0RR, and other efficacy measures (safety, complete) for oral gefitinib vs. neoadjuvant vinorelbine and carboplatin in patients with operable stage II-IIIA EGFR-mutant non-squamous cell carcinoma NSCLC. Resection rate, tumor regression, mediastinal lymph node clearance, perioperative complications, and mortality rate).

Eligibility Criteria:
Inclusion Criteria:

1. The pathological diagnosis is non-squamous cell carcinoma and non-small cell lung cancer. The pre-treatment tumor stage is stage II-IIIA;
2. The gene detects EGFR mutations is positive;
3. The age is between 18-70 years;
4. ECOG 0-1;
5. Liver and kidney function and Bone marrow hematopoiesis is normal;
6. There are no serious systemic, respiratory, cardiovascular and other important systemic dysfunctions and severe malnutrition;
7. No other malignant diseases within 5 years;
8. Patients who have not received radiotherapy, systemic chemotherapy, or biological therapy;
9. Understand the whole process of the trial and voluntarily participate in and sign the informed consent form.

Exclusion Criteria:

1. The tumor has invaded the surrounding tissue;
2. Preoperative evidence suggests that distant metastases of the lesion include contralateral mediastinal lymph node metastasis;
3. Arrhythmias require anti-arrhythmia therapy (β-blocker or digoxin Except), symptomatic coronary artery disease or myocardium. Ischemic or congestive heart failure exceeds NYHA class II;
4. severe hypertension with poor drug control;
5. moderate to severe proteinuria;
6. HIV fluHistory of infection or active chronic hepatitis B or C;
7. Malnutrition, decompensation of organ function;
8. History of chest radiotherapy;
9. Incomplete inflammation of eyes;
10. Patients with seizures that need to be treated;
11. Interstitial pneumonia;
12. Drug abuse and others that may interfere with patients' participation in the study or studyThe assessment of the results has an impact;
13. Allergies to the study drug are known or suspected to be allergic to or administered to any drug associated with this test;
14. Any instability. The condition of the patient may jeopardize patient safety and compliance;
15. Pregnancy or breastfeeding women and having fertility without adequate contraception.
Safety and Efficacy Evaluation of γ-globin Reactivated Autologous Hematopoietic Stem Cells

This is a single arm, open label, single-dose, phase 1/2 study in up to 5 participants with β-thalassemia major.The study will evaluate the safety and efficacy of the treatment with γ-globin reactivated autologous hematopoietic stem cells in subjects with β-thalassemia major.

γ-globin reactivated autologous hematopoietic stem cells will be manufactured using Glycosylase Base Editors. Subject participation for this study will be 2 year. Subjects who enroll in this study will be asked to participate in a subsequent long-term follow up study that will monitor the safety and efficacy of the treatment they receive for up to 15 years post-transplant.

Eligibility Criteria:
Key inclusion criteria:

* Fully understand and voluntarily sign informed consent. 3-35years old. At least one legal guardian and/or Subjects to sign informed consent.
* Clinically diagnosed as β-thalassemia major, phenotypes including β0β0, β+β+、β

  +β0, βEβ0 genotype.
* Subjects with no affection with EBV, HIV, CMV, TP, HAV, HBV and HCV.
* Subjects body condition eligible for autologous stem cell transplant.

Key exclusion criteria:

* Subjects acceptable for allogeneic hematopoietic stem cell transplantation and have an available fully matched related donor.
* Active bacterial, viral, or fungal infection.
* Treated with erythropoietin prior 3 months.
* Immediate family member with any known hematological tumor.
* Subjects with severe psychiatric disorders to be unable to cooperate.
* Recently diagnosed as malaria.
* History of complex autoimmune disease.
* Persistent aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin value \>3 X the upper limit of normal (ULN).
* Subjects with severe heart, lung and kidney diseases.
* With serious iron overload, serum ferritin\>5000mg/ml.
* Any other condition that would render the subject ineligible for HSCT, as determined by the attending transplant physician or Investigator.
* Subjects who are receiving treatment from another clinical study, or have received another gene therapy.
* Subjects or guardians had resisted the guidance of the attending doctor.
* Subjects whom the investigators do not consider appropriate for participating in this clinical study
Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea

The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by KFDA (Korea Food and drug administration)


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Women after menarche and before menopause
* Women requesting contraception or Women diagnosed by a physician as having HMB due to non-organic cause who are also requesting contraception
* Women who are prescribed Qlaira® for the first time, during the study period

Exclusion Criteria:

- All contraindications according to the local marketing authorization have to be considered.
A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate

The objective of this study is to evaluate the efficacy, pharmacokinetics, pharmacodynamics and safety of ASP1707 in combination with MTX in postmenopausal female patients with RA.


Eligibility Criteria:
Inclusion Criteria:

* Subject has RA that was diagnosed according to the 1987 ACR criteria or the 2010 ACR/EULAR criteria.
* Subject meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III.
* subject has active RA as evidenced by both of the followings:

  * ≥ 6 tender/painful joints (using 68-joint assessment)
  * ≥ 6 swollen joints (using 66-joint assessment)
* CRP (C-reactive protein) of \> 0.3 mg/dL or ESR (Erythrocyte sedimentation rate) of \> 28 mm/hr at screening.
* Subject who continuously received MTX and who is able to continue stable dose of MTX.
* Subject who did not receive the following drugs, or received the drugs with stable dosage:

Non-steroidal anti-inflammatory drugs, oral morphine or equivalent opioid analgesics, acetaminophen, or oral corticosteroids.

Exclusion Criteria:

* Inadequate responders to a biologic DMARD (Disease-modifying antirheumatic drug).
* Subject has taken other investigational research products are prohibited within 12 weeks (84 days) or within 5 half-lives, whichever is longer, prior to screening.
* Subject has undergone surgery which has residual effects on the assessed joints, or is scheduled to undergo surgery that may affect the study evaluation of the assessed joints.
* Subject has another type of inflammatory arthritis other than RA.
* Subject who meets any of the following criteria of laboratory values at screening:

  * White blood cell count \<4000/μL
  * Platelet count \<100000/μL
  * ALT (Alanine Aminotransferase) ≥ 2 x ULN (Upper Limit of Normal)
  * AST (Aspartate Aminotransferase) ≥ 2 x ULN
  * Total bilirubin ≥ 1.5 x ULN
  * Positive Hepatitis B surface antigen, Hepatitis B virus-DNA quantitation, or Hepatitis C virus antibody
* Subject has a positive QuantiFERON-TB Gold test or T-spot.
* Subject has a history of or concurrent malignant tumor.
* Subject has any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, infectious, or autoimmune disease except for RA, or diseases which preclude the subject's participation in the study.
* Subject has a history of clinically significant allergy.
* Subject has clinically significant abnormalities on the 12-lead Electrocardiogram.
* Subject has a history of positive Human Immunodeficiency Virus infection.
Trauma Informed Treatment Algorithms for Novel Outcomes

This randomized controlled trial (RCT) will examine the feasibility, acceptability, and preliminary efficacy of a beginning treatment for Post-Traumatic Stress Disorder (PTSD) with Behavioral Activation (BA). Cambodian men and women who screen positive for PTSD will be randomized to receive six individually delivered sessions of either: 1) Stabilization Techniques alone (ST); or 2) ST+BA. After two months, all participants who continue to report clinically meaningful elevations in PTSD will receive Eye Movement Desensitization Reprocessing (EMDR). All participants will complete a follow-up assessment at four months post-randomization.

Nearly half of the Cambodian population reports elevated levels of psychological distress and PTSD. The high levels of psychological distress are linked directly to the report of remote and more recent trauma exposures, the most notable of which is the agrarian political regime of the Khmer Rouge during the 1970s, which occurred in the aftermath of the Vietnam War. During this period, approximately 1.5 million Cambodian residents died of starvation and sickness, 500,000 individuals were executed, and another two million were displaced over the course of several years. Political stability took shape in the early 1990s after the enactment of the United Nations Transitional Authority in Cambodia. However, the prior violence undermined an already fragile healthcare system, including mental health institutions and physicians providing direct patient care.

The combination of high trauma exposure, sustained conflict, and limited psychiatric capacity has created heightened vulnerability for Cambodians, and the need to assist those struggling with PTSD. There is a pressing need to reverse this trajectory using novel approaches to address mental health needs that are effective and scalable, providing a strong basis to conduct the proposed work in Cambodia. In partnership with the Cambodian Department of Mental Health and Substance Abuse, Ministry of Health, this NIH-sponsored study will examine the feasibility, acceptability, and preliminary efficacy integrating BA into trauma treatment that is being delivered by the Mekong Project in Cambodia.

Eligibility Criteria:
Inclusion Criteria:

* Trauma exposure and screens positive for PTSD as measured by the DSM-5 PTSD Checklist (PCL-5), a 20-item scale to measure severity of PTSD symptoms
* Able to communicate in Khmer
* Able to provide informed consent as defined by ability to accurately paraphrase the purpose

Exclusion Criteria:

* Active psychosis or developmental disorder that precludes an individual's ability to provide informed consent
* Severe alcohol or substance use disorder a determined by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)

Note:

* Use of psychiatric medications will be allowed but our preliminary work revealed fewer than 5% of all individuals receive medications for PTSD
The SHINE-CTO Trial

Design: Single center, double-blind, sham-controlled trial that will randomize symptomatic patients with a coronary chronic total occlusion (CTO) to CTO percutaneous coronary intervention (PCI) or a sham procedure. All patients will receive optimal medical therapy.

Treatment:CTO PCI, as per standard clinical practice.

Control: Patients randomized to sham-procedure will undergo only bilateral arterial access, without angiography or PCI being performed.

Secondary Endpoints: (1) Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up (6 months) using a repeated measures analysis (2) Greater improvement in individual components of patients' health status (3) Greater improvement in exercise capacity (4) Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or greater
* Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
* Referred for clinically-indicated CTO PCI
* Optimal medical therapy (at least two anti-anginal medications at maximum tolerated doses, aspirin, and statin)

Exclusion Criteria:

* Coexisting conditions that limit life expectancy to less than 6 months or that could affect a patient's compliance with the protocol
* Recent (\<7 days) acute myocardial infarction
* Patient has no symptoms related to the CTO
* Known allergy to aspirin or clopidogrel
* Increased risk of bleeding (need for warfarin, oral Xa inhibitor, or thrombin inhibitor administration, recent \[within 30 days\] major bleed, known bleeding diathesis or coagulation disorder)
* Positive pregnancy test or breast-feeding
* Chronic kidney disease, defined as serum creatinine \> 2.5 mg/dL
* Severe peripheral arterial disease limiting exercise capacity
Temozolomide in Elderly Patients With KPS < 70

The management of glioblastoma in elderly patients with poor performance status (KPS\<70) is unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and safety of temozolomide alone in this population

This trial was conducted to evaluate the efficacy, in terms of survival and quality of life, and safety of up-front temozolomide in elderly GBM patients with poor performance status.

Patients of 70 years of age or older were eligible to participate in this prospective non-randomised multicentric phase II study if they had newly diagnosed and histologically proven glioblastoma on the basis of the WHO classification, and a postoperative KPS between 30 and 60.

Treatment consisted of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity.

Patients were assessed at least every month by means of physical and neurological examinations, KPS, health-related EORTC questionnaires (QLQ-C30 and QLQ-BN20), and MMSE. Complete blood counts and blood chemistry were drawn before each temozolomide cycle; the earlier were also checked every 10 days during the first 2 cycles and every 2 weeks afterwards. CT or MRI studies were repeated every 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed supratentorial glioblastoma
* Baseline contrast-enhanced CT or gadolinium-enhanced MRI study performed within the first 4 days from resection or within the first 4 weeks from diagnostic biopsy
* Patients aged 70 years or older
* KPS above 30 and below 70
* Life expectancy higher than 4 weeks
* Clinical examination at baseline
* Affiliation to Social Security or mandatory beneficiary
* Patient being informed and obtention of written informed consent

Exclusion Criteria:

* Prior surgical resection dated more than 1 month before inclusion
* Prior brain radiotherapy or chemotherapy
* Severe underlying disease which could interfere with survival
* History of hypersensibility reaction on temozolomide components
* Severe bone marrow hypoplasia
* Aspartate aminotransferase or alanine aminotransferase more than 3 times the upper limit of normal
* Absolute neutrophil count \< 1.5x109 cells per liter
* Platelet count \< 100x109 cells per liter
* Hemoglobin \< 9 g/dl
* Neuroimaging baseline examination performed beyond the first 4 days from resection or beyond the first 4 weeks from diagnostic biopsy
Color-dependent Melatonin Suppression

The purpose of this study is to examine the effects of complex, broad-band spectra light on the production of melatonin in humans.


Eligibility Criteria:
Inclusion Criteria:

* Stable health
* Normal color vision
* Normal hearing
* 18-35 years old

Exclusion Criteria:

* Significant depressive symptoms
* Pregnant or nursing
* Ocular pathologies
* Unstable or severe medical or psychiatric condition
* Extreme morning/evening type
* Regular smoker
* Use of medications that impact ocular function
* Alcohol use disorder
* Use of illegal drugs
* Irregular use of antihistamines, antidepressants, or sleeping medications
Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex

Background: Alzheimer's disease (AD) is characterized by cognitive impairment and behavioral impairment, and increasing attention is paid in the gait of AD patients. The aim of this randomized controlled trial (RCT) is to explore the effect of acupuncture on the cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices.

Methods: In this RCT, a total of 108 AD patients will be randomly assigned into acupuncture group or control group for 8 weeks. The primary outcome will be Three-dimensional gait analysis and cerebral hemodynamics using functional near-infrared spectroscopy (fNIRS). Secondary outcomes include Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Barthel Index (BI).

Discussion: This trial is expected to explore the effect of acupuncture on cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices for AD patients.

This study aims to assess the clinical effect of acupuncture on gait performance in AD patients and to examine the acupuncture effect on cerebral cortices by identifying hemodynamic changes that occur in the prefrontal cortices using the fNIRS technique.

Eligibility Criteria:
The inclusion criteria are as follows:

1. Aged 40-85 years old;
2. Meeting the mentioned-above diagnostic criteria from traditional Chinese medicine and Western medicine;
3. With mild to moderate dementia (CDR=0.5, 1.0, or 2.0 points);
4. Hachinski Ischemic Scale (HIS) ≤ 4 points;
5. Hamilton Depression Rating Scale (HAMD) \< 20 points;
6. Without severe bone and joint diseases and able to walk independently;
7. Able to conduct vision and hearing tests;
8. Volunteering to participate in this trial and signing an informed consent form. Exclusion criteria

The exclusion criteria are as follows:

1. Dementia caused by other systemic or neurological diseases, such as central nervous system infections, post-traumatic dementia, Parkinson's disease dementia;
2. Suffering from acute illness, upper limb extrapyramidal stiffness, neurological or psychiatric disorders (except cognitive impairment);
3. With medical history that interferes with cognitive function assessment, such as past history of psychiatric drug abuse, drug addiction within the past 5 years, and alcohol abuse;
4. Afraid of acupuncture and cannot accept acupuncture treatment;
5. Currently participating in other clinical trial that affects the outcome evaluation of this trial.