cyrilzakka/clinical-trials huggingface dataset:
ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

The goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. The researchers will compare the outcomes between the two groups to see if the PFS between the two groups is similar.


Eligibility Criteria:
Inclusion Criteria:

1. Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;
2. Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects);
3. Patients with negative ctDNA after surgery;
4. ASA grade \<IV and/or ECOG performance status score ≤ 2;
5. Have sufficient understanding of the study and voluntarily sign an informed consent form.

Exclusion Criteria:

1. Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.;
2. Patients with a history of other malignancies;
3. Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy;
4. Patients who are allergic to any component in the study;
5. Patients who have received other tumor-related investigational drug therapy;
6. Patients with severe uncontrolled recurrent infections or other serious uncontrolled concurrent diseases;
7. Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases that require comprehensive treatment (including mental disorders), and serious abnormal laboratory tests;
8. Patients with a history of severe mental illness;
9. Pregnant or lactating women;
10. Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.
Efficacy of 1072nm Infrared Stimulation on Executive Functioning in Dementia

This study will employ a double-blind, placebo-controlled approach to assess the effect of 1072nm infrared (IR) phototherapy on the behavioral and cognitive symptoms associated with early and mid-stage dementia.

What hypotheses are you testing?

We are seeking to determine if the provision of brief, repeated exposure to 1072nm infrared stimulation of the cortex surface improves cognitive and behavioral functioning as indicated by normalization of EEG activity, increased cerebral oxygenation and demonstrated improvement on standardized neuropsychological measures.

Intensive near infrared stimulation has been shown to be effective in accelerating healing of injuries and functional modification including increasing blood flow and perfusion. Dementia research has suggested that hypoperfusion is a significant underlying mechanism in the progression of dementia. Infrared spectroscopy has been shown effective in the non-invasive measurement of changes in cerebral oxygenation and perfusion. This study therefore seeks to explore whether the increasing of regional cerebral perfusion and oxygenation using infrared light stimulation will result in improved cognitive and behavioral functioning.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 50 - 85 years.
* Have established cognitive impairment, Mini Mental Status Examination (MMSE) score between 15- 25 (from a possible score of 30).
* Generally healthy otherwise as indicated by recent physical examination.
* Have a caregiver/informant who has cared for the patient at least 5 days a week and is willing to attend study visits and provide information about the patient.
* If taking any psychotropic medication should have been stable for the previous 3 months.
* Must have had B12, folic acid, full blood count and ferritin screen within the previous 6 months or be on B12 and/or folic acid replacement.

Exclusion Criteria:

* Uncontrolled or unstable chronic illness, e.g., hypertension, chronic obstructive pulmonary disease (COPD).
* Diagnosed actively growing intracranial pathology (tumors etc).
* An associated psychotic illness.
* Misusing illegal substances or alcohol.
* On regular systemic steroids or anti-metabolites.
* Systemic malignancies and/or space occupying lesions in the brain.
* Not fluent in English.
* Depressed as assessed by Beck Depression Inventory score.
* Epilepsy.
* Lacking the capacity to give informed consent.
* Previous history of stroke or heart attack.
* History of aggression or violence.
* Inability to travel to the research venue for multiple assessments.
* A history of major psychiatric illness, seizure disorder, or physical illness that would compromise their participation in a daily treatment regimen.
* A participant may be disqualified if their performance is above the normative mean or below the lowest interpretable score of neuropsychological tests provided during the initial assessment (see #6, Sources of research material obtained from study participants, below).
Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness.

Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness: A longitudinal Study

this study will be conducted to show the long term effect of combined vestibular rehabilitation incorporating optokinetic stimulation and virtual reality exercises on persistent postural perceptual dizziness patients.

Aim:1.Evaluate the balance control function in patients with persistent postural perceptual dizziness using computerized dynamic posturography.

2.To study effect of rehabilitation using optokinetic stimulation and virtual reality on persistent postural perceptual dizziness patients.

3.To follow up patients after the vestibular rehabilitation therapy to study the persistence of improvement" if any" in patients with persistent postural perceptual dizziness .

Type of the study : prospective cohort and longitudinal study. Sources of data : Audio-vestibular medicine unit , Sohag University Hospital. Study group : consists of 36 patients age ranged from 18-65 years suffering from symptoms of persistent postural perceptual vertigo.

All subjects will be submitted to:

A- Detailed medical history, full history of dizziness. B-Acoustic impedance test. C-Basic audiological evaluation. D- Vestibular assessment.

Eligibility Criteria:
Inclusion Criteria:

* Age: from 18 years to 65 years old.
* Gender: males and females.
* Can withstand and willing to undergo repeated vestibular rehabilitation therapy .\*No history of any disease required to give treatment that could affect results.

Exclusion Criteria:

* Neurological disorders, paresis, paralysis, motor disorder, ataxia, brain mass, multiple sclerosis and stroke with grade 4 muscle power or below.
* Otological disorders e.g. middle ear pathology (chronic suppurative otitis media, Tumor).
* Psychiatric disorders e.g. Schizophrenia and endogenous depression.
* Severely ill patients who would not tolerate vestibular rehabilitation therapy .
Brexpiprazole (OPC 34712) Trial in the Treatment of Adults With Major Depressive Disorder and Irritability

The purpose of this study is to explore the effects of fixed-dosed brexpiprazole adjunctive treatment in subjects with Major Depressive Disorder with irritability


Eligibility Criteria:
* Inclusion Criteria:

  * Are 18 to 55 years of age, inclusive, at the time of informed consent with a diagnosis of a single or recurrent, nonpsychotic episode of MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR™) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) and an adequate clinical psychiatric evaluation
  * Have received a single, trial-approved SSRI or SNRI at an adequate dose for ≥ 6 weeks prior to screening
  * Have a treatment history of inadequate ADT response to at least one ADT (but not \> 3) for the current episode. The current major depressive episode must be ≥ 6 weeks in duration. (An inadequate ADT response is defined as \< 50% reduction in depressive symptom severity, as measured by subject self-report on the MGH-ATRQ.)
  * To be eligible for this trial

    * Have a MADRS Total Score of 20 or more at screening and the Phase A baseline, and have a MADRS Total Score of 18 or more at the Phase B baseline
    * Have no more than 20% improvement in MADRS Total Score at Phase B baseline compared to Phase A baseline
    * Have a score of 6 or more on the KSQ based on the Well being and Reversal Distress Anger-hostility subscales at screening, Phase A baseline, and Phase B baseline
    * Have anger attacks as documented by the AAQ at screening, Phase A baseline, and Phase B baseline
  * Are right-handed (defined according to the Edinburgh Handedness Inventory) and have normal hearing and normal/corrected-to-normal vision
  * Are willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period
  * Eligibility confirmed through a telephone SAFER interview with the subject and an independent expert centralized rater
* Exclusion Criteria:

  * Have a current need for involuntary commitment or have been hospitalized within 4 weeks of screening for the current major depressive episode
  * Have a current DSM-IV-TR Axis I diagnosis of any of the following: delirium, dementia, amnestic, or other cognitive disorders; schizophrenia, schizoaffective disorder, or other psychotic disorders; bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified; eating disorders (including anorexia nervosa or bulimia); obsessive compulsive disorder; panic disorder; or post-traumatic stress disorder
  * Have any of the following current Axis II DSM-IV-TR diagnoses: borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorders, or mental retardation
  * Experiencing hallucinations, delusions, or any psychotic symptomatology in the current major depressive episode
To Evaluate The Anrogens and Ovary Function in In Vitro Fertilization

Because the society convention is changed, people are late for getting married, leading to increasing the bearing age in women. According to the previous study, if the age is over 30, the oocyte number in ovary has left only 10％ and 3％ in over 40 years old. The data is collected by Bureau of Health Promotion, Department of Health shows that there are about 7000 people treating the infertility and it spends about 150000 to 250000 NT dollars in every in vitro fertilization (IVF) cycle, but the live birth rate is only 30％. So it is important to know how to estimate and approve the ovary function that lead to increase the live birth rate. The investigators plan to estimate the correlation between the serum androgens levels and pregnancy outcome in the women who have infertility problem. Furthermore, for the repeated IVF cycle, the ovary function might be re-evlauated because of the possible effect from stimulated drugs used on previous cycle. It's important to understand the ovary function for IVF patient to choose the appropriate drugs and dose.

The investigators use blood and clinical test to analyze, the items for analysis are below:

1. Routine blood test: FSH、LH、E2、P4、Anti-Mullerian Hormone(AMH)、
2. Studied blood test: Inhibin B、total testosterone (TT)、Androstenedione、DHEA-S
3. Clinical test: Ultrasound
4. Personal condition. In order to finishing the test, every patient will be asked to collect about 10 to 15 cc blood for the research.


Eligibility Criteria:
Inclusion Criteria:

* This study include the patients who are evaluated by the doctors and are sure to process the IVF cycle.

Exclusion Criteria:

* This study exclude the patients who are not evaluated by the doctors and are not sure to process the IVF cycle.
Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women

The study was done to elucidate relationships between midlife women's self-reported hot flashes, neuropsychological symptoms, cognitive performance or sleep.


Eligibility Criteria:
Inclusion criteria:

* At least 5 hot flash episodes and/or night sweats per 24 hours

Exclusion Criteria:

* Body mass index (BMI) more than 34 kg/m2
* Hypertension
* Shift work
* Psychiatric or medical conditions that would affect outcome measures
* More than 4 caffeine drinks per day
* More than 10 cigarettes per day
* More than than 7 alcohol drinks per week
Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients

The proposed study is a randomized, placebo-controlled clinical trial to test the efficacy of an oral Lactobacillus product dissolved in sterile saline and instilled into the urinary bladder in an attempt to colonize the urinary bladder as well as prevent UTIs.

Patients who use a chronic indwelling urinary catheter to drain their bladder will be randomized to receive intravesical instillations of a Lactobacillus solution or sterile saline at the time of a scheduled monthly catheter exchange. Bacterial colonization and frequency of urinary tract infections will be compared between the two groups.

The Lactobacillus solution will be derived from the combination of Lactobacillus rhamnosus (GR-1®) and reuteri (RC-14®) species, which is offered as an over the counter probiotic capsule sold under the brand name of Femdophilus and manufactured by CHR-Hansen of Denmark (phone: +45 45747474; email: info@chr-hansen.com). The contents of the capsules will be dissolved in 50 mL of normal saline at room temperature within one hour prior to administration and left indwelling in the patient's urinary bladder for 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Chronic indwelling urethral catheter or supra-pubic tube for \>6 months
3. Prior symptomatic UTI while catheter in place

Exclusion Criteria:

1. Immunosuppressed (HIV, transplant immunosuppression, uncontrolled diabetes)
2. Active infection (may be considered after treatment of active infection)
3. Prior urosepsis requiring ICU admission
4. Significant gross hematuria resulting from catheter exchanges
5. Supravesical urinary diversion
6. Upper urinary tract anatomical abnormality
7. Obstructing urolithiasis
8. Ongoing antibiotic therapy for non-urological infection
9. Indwelling nephrostomy tube or ureteral stent
10. Radiation cystitis
11. Pregnancy
Tele-Rehabilitation in Individuals With Covid-19

Coronavirus Disease (COVID-19) is a respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-cov-2). This study was planned as a single-blind randomized controlled pilot study to compare the effectiveness of telerehabilitation-based exercise training applied to individuals with Covid-19. Individuals will be divided into two groups, the control group and the study group. All assessments will be made online twice, before and after treatment. Socio-demographic data of individuals who agreed to participate in the study, disease information about Covid-19, MRC Dyspnea Scale, COVID-19 Fear Scale, International Physical Activity Questionnaire-Short Form, ST. George Respiratory Questionnaire, Fatigue Severity Scale, Nottingham Health Profile will be questioned and recorded. The obtained data will be analyzed with statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* A score in the range of 0-3 on the MRC Dyspnea Scale.
* Not have any vestibular, orthopedic or neurological disease that will affect muscle strength, balance and coordination.
* Not having undergone surgery in the last 6 months.
* Not having undergone any surgical procedure that may affect the musculoskeletal system of the spinal column, lower extremities or upper extremities.
* It was being cooperative and volunteering.

Exclusion Criteria:

* Severe liver and kidney disease or new and progressive damage to liver and kidney function, deep vein thrombosis and pulmonary embolism, suspected aortic stenosis, having a disease/condition for which exercise is contraindicated.
Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile

Suboptimal reversal of neuromuscular blockage after surgery is possibly related to unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete reversal of neuromuscular block was not possible untill sugammadex was discovered. The investigators hyposthesise that reversal with sugammadex leads to favorable postoperative respiratory conditions and less pain compared to reversal with neostigmine.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years
* - BMI \< 35
* -ASA class I- III
* -Patients scheduled for surgery requiring general anesthesia with the use of NMBA's

  * Patients with ability to give oral and written informed consent

Exclusion Criteria:

* Failure to meet the inclusion criteria

  * -Known or suspected neuromuscular disorders impairing neuromuscular function
  * -Allergies to muscle relaxants, anesthetics or narcotics
* A (family) history of malignant hyperthermia

  * -Women who are or may be pregnant or are currently breast feeding
  * -Contraindications for the use of neostigmine
* Intestinal obstruction,
* COPD GOLD 4

  * -Abnormal heart rhythm (eg. bradycardia: \< 40/min);
  * -Surgery requiring neuraxial anesthesia / analgesia
  * -Preoperative cognitive dysfunction or mental disabilities
  * -Preexistent significant pulmonary disease with preoperative SpO2 \< 90%
  * -Preoperative ICU treatment / intubation (ICU patient);
  * -Need for postoperative ICU treatment or ventilation;
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).


Eligibility Criteria:
Inclusion Criteria:

* ≥ 12 years of age at the time of informed consent.
* New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
* History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.
* Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.
* Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
* Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose ≥ 1.0 mg/kg per day (or methylprednisolone equivalent) for cGVHD.
* Received previous systemic treatment for cGVHD, including extracorporeal photopheresis.
* Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
* Prior treatment with CSF-1R targeted therapies.
* Active, uncontrolled bacterial, fungal, parasitic, or viral infection.
* Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse.
* History of acute or chronic pancreatitis.
* Active symptomatic myositis.
* History or current diagnosis of cardiac disease indicating significant risk of safety for participation in the study, such as uncontrolled or significant cardiac disease.
* Severe renal impairment, that is, estimated CrCl \< 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or endstage renal disease on dialysis.
* Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD.
* Pregnant or breastfeeding.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
DHEA Against Vaginal Atrophy - Safety Study of 12 Months

The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.


Eligibility Criteria:
Main Inclusion Criteria:

* Postmenopausal women (non-hysterectomized)
* Women between 40 and 75 years of age.
* Willing to participate in the study and sign an informed consent.
* Women who have self-identified symptom(s) of vaginal atrophy.
* Willing to have endometrial biopsy at screening and end of study (Week 52).

Main Exclusion Criteria:

* Undiagnosed abnormal genital bleeding.
* Hypertension equal to or above 140/90 mm Hg.
* The administration of any investigational drug within 30 days of screening visit.
* Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.
According CTC to Compare the Influences of Different Methods to Remove the PDAC

Acccording circulating tumor cells to compare the differences of different methods(routine method、no-touch principle method、laparoscopy method) to remove the ductal adenocarcinoma of pancreatic body and tail.


Eligibility Criteria:
Inclusion Criteria:

* Ductal adenocarcinoma of pancreatic body and tail
* Tumor can be removed
* No other tumors and without liver metastases
* Age from 18 to 80 years old

Exclusion Criteria:

* Neoplasms with other sites of the pancreas
* With other tumors of any other sites