cyrilzakka/clinical-trials huggingface dataset:
Investigating Racing Thoughts in Patients With Insomnia Disorder

Cognitive arousal has been identified as playing a key role in the inability to fall asleep or stay asleep. However, although people with insomnia frequently complain about racing thoughts appearing as soon as they get into bed, studies focusing on racing thoughts in insomnia are lacking. The aim of the present study is to investigate racing thoughts in insomnia disorder using a self-report questionnaire, the Racing and Crowded Thoughts Questionnaire. Specifically, the researchers seek to address three related goals: the comparison of RCTQ scores in adults with primary insomnia, healthy individuals, and patients with bipolar disorder in a manic/hypomanic episode; the variation of RCTQ scores relative to time of day; and the specific contribution of racing thoughts to insomnia severity, as compared to worry and rumination.


Eligibility Criteria:
Inclusion Criteria:

* Major subject from 18 to 70 years old)
* with a diagnosis of chronic primary insomnia according to the criteria of ICSD-3
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice
* Patient with secondary insomnia (OSA, circadian rhythm disorder, severe restless legs syndrome, bipolar disorder, ADD +/- H)
* Subject under psychotropic treatment other than hypnotics
* Incomplete data concerning the main endpoint
Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Multiple centers, uncontrolled, open-label, non-randomized single-arm study

To evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving GSL treatment, Primary objective: Overall tumor response rate (by RECIST criteria)

Secondary objectives:

Disease control rate (Objective response rate + stable disease ≧ 16 weeks) Time to tumor progression Progression-free survival Overall survival Clinical benefit response Quality of life Safety profile Biomarker of pancreatic cancer

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas.
2. Patients have disease measurable or evaluable on x-ray, computed tomography scan, or physical examination.
3. Patients have no history of prior chemotherapy for metastatic pancreatic cancer. Patients who had received chemotherapy as in an adjuvant or neoadjuvant setting which was completed at least 6 months before recurrence are eligible.
4. Patients with prior radiotherapy are eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
5. Baseline ECOG performance status is 2.
6. Patients have life expectancy of at least 12 weeks.
7. Patients have age 70 years.
8. Patients have adequate organ function.
9. Patients with biliary obstruction which is adequate drained before enrollment are eligible.
10. Patients agree to have an indwelling venous catheter implanted.
11. Women or men of reproductive potential should agree to use an effective contraceptive method.
12. All patients must be informed of the investigational nature of this study and must sign written informed consents.

Exclusion Criteria:

1. Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible if the irradiated area does not involve the only lesion of measurable / evaluable disease.
2. Patients with metastatic lesion in central nervous system.
3. Patients with active infection.
4. Patients with active cardiopulmonary disease or history of ischemic heart disease.
5. Patients who have peripheral neuropathy \> grade I of any etiology.
6. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
7. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately.
Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA)

An ongoing long-term cohort study is conducted in the Sun Yat-sen Memorial Hospital of Sun Yat-sen University, that is dedicated to recruiting RA patients, to identify the development of clinical, neuroimaging, and biochemical biomarkers for the diagnosis and prognosis of RA, especially for those with sarcopenia/myopenia

To improve the prognosis of RA, this study includes the following objectives:

1. Construct a useful database to explore the secular dynamic progress of RA, especially the difference between early and lately RA, as well as to improve our understanding of the life-course factors affecting the process that will facilitate future research activities.
2. Identify the potential markers (clinical, biomedical and imaging) affecting/predicting the development process of sarcopenia/myopenia or other prognosis in RA patients.
3. Develop the related multi-modal prediction models with clinical, biomedical and imaging variables to improve the diagnosis and prognosis of RA.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older and diagnosed with RA according to 1987 ACR or 2010 ACR / EULAR classification criteria

Exclusion Criteria:

* Patients diagnosis with tumors without control, or AIDS
* Patients with serious disease in cardiovascular, kidney and blood and endocrine system; and 3) history of schizophrenia or epilepsy
Safety of Human Embryonic Stem Cell (hESC)-Derived Mesenchymal Stem Cells in Interstitial Cystitis

This study primarily aimed to evaluate the safety of human embryonic stem cell (hESC)-derived mesenchyma stem cells in interstitial cystitis.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged \>= 20 years
* Interstitial cystitis symptom duration more than 6 months
* Presence of Hunner lesions in outpatient cystoscopy (within one months of screening), with size \< 2cm, number \<= 2
* VAS (Visual pain analogue scale) \>=4 in screening symptom questionnaire
* Those who are suitable for stem cell transplantation

  * normal laboratory findings (hematological, chemical)
  * no history of drug abuse
  * negative HIV, HBV, HCV serology tests
  * No history of malignancies
  * willing to contraception
  * no plan for blood, tissue donation
* Who can understand consent form and willing to participate in the study

Exclusion Criteria:

* recurrent urinary tract infection ( more than twice per past six months or more than three times per past one year) or active urinary tract infection
* any active or past history of tuberculosis or systemic infection
* Anatomical abnormality of lower urinary tract
* History of following procedures

  * stem cell transplantation In past 6 months,
  * transurethral resection/fulguration of Hunner lesion or hydrodistension of bladder
  * intravesical instillation of ialuril
  * hysterectomy, anti-incontinence surgery, transvaginal surgery, pelvic organ prolapse repair, vagina delivery or C/sec
  * any neurological conditions including cerebrovascular disease, multiple sclerosis, spinal cord injury, Parkinson disease
  * indwelling Foley catheter or intermittent catheterization
  * any plans for electrostimulation, neuromodulation, physiotherapy or operation for other organs
  * any history of malignancy
  * history of myocardiac infarction in past 12 months
  * Uncontrolled diabetes (HbAlc \>= 7.2%) or diabetes requiring insulin injection
  * Uncontrolled hypertension (systolic \>170mmHg or \<90mmHg, diastolic \>100mmHg or \<50mmHg)
  * Immunodeficiency
  * Positive HBV, HCV, HIV, syphilis
  * pregnant or on breast feeding
  * any history of drug, alcohol abuse. mis-use
  * Any significant signs, symptoms or previous diagnosis of psychological disorder
  * Impossible to follow scheduled visits
  * Currently participating or participated in other clinical studies within past 3 months
  * Allergic to protein products (serum), antibiotics (gentamicin), DMSO (Dimethyl sulfoxide)
  * Any circumstances that is not suitable for participating or continuing clinical study or participants who clinical investigator considers not suitable for participation
Long-term Physical Training in Chronic Obstructive Pulmonary Disease

Several impairing factors contribute to physical limitation in chronic obstructive pulmonary disease (COPD) as deconditioning, muscle dysfunction and physical inactivity. The available literature clearly indicates that these therapeutic targets benefit from exercise training in patients with COPD and, currently, the key point is not whether patients should or not exercise, but which is the specific contribution of each exercise modality to this population. About this topic, the characteristics of a physical training program to be offered to patients have been a point discussed among researchers in this field, although recently the high-intensity training has been recognized as superior in comparison to the low-intensity training. Literature also indicates that, in order to change the sedentary lifestyle of patients with COPD, long-term training programs are indicated. However, a doubt still remains: if long-term programs are one of the key points to reduce physical inactivity, it is not yet clear whether it is necessary to include high-intensity exercises in that long-term program. If the duration is the only factor influencing the outcomes of the program, thus the intensity of training could be reduced, increasing the adherence of patients to the protocol. Based on this hypothesis, the aim of this study is to compare the effects of two physical training protocols in a long-term rehabilitation program (6 months) in patients with COPD: a high-intensity protocol (based on endurance and resistive training) and a low-intensity protocol (based on callisthenic and breathing exercises training). It is expected that the results of this study contribute to the scientific literature by demonstrating whether low- and high-intensity training contribute equally to change the sedentary lifestyle of patients after a long-term exercise program.


Eligibility Criteria:
Inclusion Criteria:

* Chronic obstructive pulmonary disease (COPD) diagnosis according to Global Initiative for Chronic Obstructive Lung Disease(GOLD)criteria
* Clinical stability (i.e. absence of acute exacerbation in the last 3 months)
* Absence of any unstable/severe cardiac,osteoarticular or neuromuscular disorders which could limit physical activities in daily life
* Non participation in pulmonary rehabilitation in the last year

Exclusion Criteria:

* Being unable to attend the outpatient clinic three times per week
* Inability to understand or cooperate with the assessment methods
The Utility of Breath Biopsy as a Screening Tool for HCC

The aim of this pilot study is to examine whether there is a discriminating ability of the breath sample analysis to capture biomarkers specific to the HCC in the breath of affected individuals. If positive, our research could open up a new horizon for cost-effective and feasible screening tools.

20 Participants will be included in the study. Ten Cirrhotic patients with HCC and 10 Cirrhotic patients without HCC.

The first group is patients with HCC secondary to cirrhosis. The second group will be patients with cirrhosis who are currently on the standard surveillance program with no HCC. Confirmation of the absence of HCC would have been ensured via a recent advanced imaging modality (dynamic CT scan or MRI) in the ongoing surveillance programme.

Participants will breathe into either a mouthpiece or collection tube then Breath samples will be analyzed via an analyzer to detect the volatile organic compounds (VOC) and quantitatively compare them

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients with HC.
* Cirrhotic patients without HCC

Exclusion Criteria:

* Patients with more than one primary cancer (HCC in addition to other cancer)
* Patients who are not aware of the diagnosis
* Patients in whom the diagnosis of HCC is not clear and only suspected
* Patients with severe chronic obstructive pulmonary disease (COPD) or severe asthma.
Improving Care After Inherited Cancer Testing

The IMPACT Study seeks to refine and evaluate the effectiveness of interventions on improving guideline-adherent cancer risk management (CRM) and family communication (FC) of genetic test results for individuals with a documented pathogenic/likely pathogenic (P/LP) variant, and FC of family cancer history for individuals with a variant of uncertain significance (VUS) in an inherited cancer gene.

Through recruitment of a racially, geographically, and socioeconomically diverse sample of patients, we will achieve the following aims:

1. Evaluate factors associated with access to genetic risk assessment, counseling, and testing services.
2. Conduct a randomized controlled trial to assess the effectiveness of interventions on improving guideline-adherent CRM and FC of genetic test results among individuals with a P/LP variant in an inherited cancer gene.
3. Conduct a pilot study to assess the effectiveness of an intervention on improving FC of family cancer history among individuals with a VUS in an inherited cancer gene.
4. Create and pilot an adaptive intervention to tailor resources to promote CRM and FC.
5. Document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations.

Eligibility Criteria:
Randomized Controlled Trial Eligibility: All trial participants will be autonomous adults who are capable of participating in the study

Inclusion Criteria:

* English-speaking men and women aged 18 years or older
* Not adopted (i.e., have information about their biological relatives)
* Have access to internet and a computer, tablet, or smartphone
* Documented pathogenic/likely pathogenic variant in an inherited cancer gene that has CRM guidelines listed in the National Comprehensive Cancer Network (NCCN) Genetic/Familial Panel focused on Breast, Ovarian, and Pancreatic or Colorectal cancers
* Must meet at least one of the following criteria:

  * Intervention A (GeneSHARE) criteria: Have at least one at-risk adult, living relative who either:

    * has not been told about the genetic test result by the participant
    * has not had their own genetic testing
  * Intervention B (LivingLabReport) criteria: Are non-adherent (i.e., either undertreatment or overtreatment) to at least one of the current NCCN CRM guidelines or if currently adherent, require ongoing cancer screening

VUS Pilot Study Eligibility: All VUS pilot study participants will be autonomous adults who are capable of participating in the study. Eligibility criteria include:

* English-speaking men and women aged 18 years or older
* Not adopted (i.e., have information about their biological relatives)
* Have access to internet and a computer, tablet, or smartphone
* Documented VUS in an inherited cancer gene
Study of PaQ™ (a Simple Patch on Insulin Delivery Device) in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the ability of a patient, who has type 2 diabetes (T2DM) who is currently treated with basal/bolus insulin therapy, to use PaQ™ (a simple patch on insulin delivery device) to control his/her blood glucose.

This is a single center, open label, feasibility of use and performance evaluation of PaQ™ (using insulin aspart) in patients with T2DM who are currently receiving basal/bolus insulin therapy with or without oral anti-diabetic drugs (OADs) for glycemic control. The patient's participation in the study is comprised of four phases: screening, baseline evaluation, transition to PaQ™ use, and PaQ™ treatment period. The use of these phases will allow an orderly transition to PaQ™ treatment as well as a reliable construct from which to interpret the final data.

Eligibility Criteria:
Inclusion Criteria:

1. Male/female patient's ≥ 30 ≤ 65 years of age.
2. Clinical confirmation of T2DM diagnosis by history and medication usage or glucose tolerance test.
3. Currently treated with insulin using a basal/bolus regimen with or without concurrent use of OADs (metformin and/or glitazone).
4. Currently on a stable insulin regimen "as judged by the investigator" (using an estimate of their basal dose of insulin does not fluctuate by more than ±10% every day) and if he/she is receiving a concurrent oral agent, the dose has remained unchanged for the last 30 days.
5. Currently uses between 20 to 50 units/day basal insulin.

Exclusion Criteria:

1. Uncontrolled hyperglycemia, HbA1c \> 9.0% requiring adjustment to his/her insulin regimen.
2. Treated with premixed insulin, or neutral protamine hagedorn (NPH)/glargine/detemir insulin without use of bolus/meal time insulin.
3. Patient has had an episode of severe (assisted) hypoglycemia within the past 30 days.
4. Currently treated with sulfonylurea or incretin-based therapy \[glucagon-like peptide-1(GLP-1) agonist or dipeptidyl peptidase-4 (DPP-4) inhibitor\].
5. Total daily dose (TDD) of insulin is \>100 units/day.
6. Have a meal-time bolus doses that exceeds the capacity of the bolus Insulin Reservoir at any given meal.
7. Have existing dermal irritation on their abdomen or have known hypersensitivity to skin adhesives.
8. Taking or has taken prednisone or cortisone medications in the previous 30 days.
9. Pregnant or is planning to become pregnant during the study period.
10. Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.
11. Unable to follow the study clinical investigational plan (CIP)
A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment

This study is a single center, single arm, open study design. The main purpose of this study is to evaluate the tolerance and efficacy of SHR1701 with synchronous radiotherapy in patients with metastatic non-small cell lung cancer who have failed after systematic treatment. Large fraction radiotherapy is given to all lesions as much as possible, and low-dose radiotherapy is given to the lesions that cannot be tolerated or have no obvious benefit.


Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily participate in this study and sign informed consent.
* NSCLC in stage IV.
* No clear driven genes (including but not limited to EGFR、ALK、ROS1、cMET).
* Previously received more than 1 chemotherapy regimen and progressed/ recurred.
* At least one lesion is suitable for hypofraction radiotherapy.
* There is at least one measurable lesion.
* 18 to 75 years old
* ECOG 0-1
* The function of vital organs meets the following requirements. ANC ≥ 1.5×10\^9/L, PLT≥100×10\^9/L, Hb≥9g/dL, ALB≥3g/dL, TSH ≤ULN, Bilirubin ≤ 1 times ULN; ALT and AST ≤1.5 times ULN. AKP ≤ 2.5 times ULN. CREA ≤1.5 times ULN or CCr≥60mL/min#
* The estimated survival period is more than 3 months.
* Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment

Exclusion Criteria:

The subjects had any history of autoimmune disease or active autoimmune disease.

* Subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.It is still in use within 2 weeks of the entry.
* Subjects with severe allergic reactions to other monoclonal antibodies.
* The subjects had a central nervous system metastases of clinical symptoms.
* Central squamous cell lung carcinoma.
* Imaging (CT or MRI) shows that tumors invade large blood vessels or are indistinct with blood vessels.
* Imaging (CT or MRI) showed significant pulmonary vacuity or necrotic tumors,Borderline adenocarcinoma accompanied by a cavity can be considered after discussion with investigator.
* Failing to properly control the clinical symptoms or disease of the heart.
* Subjects had active infections.
* Subjects may receive other systemic antitumor therapy during the study period.
* Other clinical trials of drugs were used in the first four weeks of the first medication.
Preventing Childbirth-Related PTSD With Expressive Writing

The goal of this clinical trial is to test a brief psychological intervention given to individuals in the first days following childbirth who have experienced a potentially stressful childbirth. The treatment is aimed at preventing post-traumatic stress disorder following childbirth and promoting maternal-infant bonding.

In the days following childbirth, participants will be asked to write about their childbirth experience or a neutral event for three consecutive days, for around 15 minutes each day. Additionally, they will complete a short survey before and after the intervention about their birth experience and mental health. Around 2 months postpartum, participants will take part in mental health and physiological assessments, and in a brief play session with their infant.

Childbirth-related PTSD (CB-PTSD) is a debilitating maternal mental disorder that undermines the well-being of mothers and can interfere with bonding with their infants during an important time of infant development. A significant portion of delivering women, particularly those who have experienced complicated deliveries, are at-risk for developing CB-PTSD. Underrepresented minorities are also at higher risk for CB-PTSD. An estimated 240,000 American women are likely to be affected by CB-PTSD each year.

Currently, there is no recommended intervention for individuals exposed to traumatic childbirth in hospitals in the United States. Immediate postpartum interventions delivered to at-risk women that are low-cost, low-burden, and feasible are lacking. This study will attempt to fill this gap in effective treatment. Evidence shows that expressive writing (EW), or briefly disclosing in writing mainly thoughts and feelings about a highly stressful event, can have positive effects on mental and physical health. Therefore, the investigators will test the therapeutic effects of EW about recent childbirth in women at-risk for CB-PTSD.

Eligibility Criteria:
Inclusion Criteria:

* Women who recently delivered at Massachusetts General Hospital (MGH).
* Women who are at risk for developing CB-PTSD based on their scoring of \>16 on the Peritraumatic Distress Inventory (PDI).

Exclusion Criteria:

* Age \<18 or \>50.
* Preterm delivery (\<37 week gestation) or stillbirth.
* Down's Syndrome, other serious genetic disorder in the newborn, or serious birth defect (e.g., microcephaly, spina bifida).
* Admission to the neonatal intensive care unit (NICU) for more than 24 hours.
* Current diagnosable DSM-5 psychotic or bipolar disorder, or current substance abuse disorder.
* Active suicidality (assessed case by case).
* Present substance abuse as indicated in medical records.
* Severe maternal morbidity (assessed case by case).
* General anesthesia.
* Inability to understand the study procedures, risks, and side effects, or to otherwise give informed consent for participation due to neurological or other reasons.
* Inability to understand English.