cyrilzakka/clinical-trials huggingface dataset:
Slow-wave Sleep Deprivation in Depression

Sleep deprivation can acutely reverse depressive symptoms in patients with major depression. Although underlying mechanisms of the antidepressant action in sleep deprivation are unclear, many of these observations can be explained by abnormal slow wave homeostasis. This study will test the prediction that selectively reducing slow waves during sleep (slow wave deprivation; SWD), without disrupting total sleep time, will yield an antidepressant effect.

see above

Eligibility Criteria:
Inclusion Criteria:

* Among the inclusion criteria will be:

  * age range 18-35 years
  * right handedness
  * major depressive disorder according to DSM-IV (Diagnostic and Statical Manual-Revision 4) criteria (as determined by the Structured Clinical Interview for Diagnostic and Statical Manual-Revision 4), with Hamilton Rating Scale for \*Depression scores of at least 18 on the first 17 items
  * no psychotropic medications for at least 4 weeks
  * no joint and muscular di
  * normal hearing
  * regular bedtimes and sleep duration, no time zone shifts in the last three weeks.

Exclusion Criteria:

* Diabetes requiring insulin treatment
* A serious heart disorder or subjects who have had a heart attack within the last 3 months
* A diagnosis of cancer in the past 3 years and/or has active neoplastic disease
* Clinically significant abnormalities on pre-study physical exam or physician evaluation
* Subjects who meet DSM-IV (Diagnostic and Statical Manual-Revision 4) criteria for alcohol/drug abuse problems within the last six months or are currently using illegal drugs.
* Female subjects of child-bearing potential who are pregnant or planning to become pregnant.
* Women of child-bearing must be practicing a medically acceptable form of birth control.
* Women of childbearing potential will be questioned about pregnancy status and form of birth control to be used at each visit.
* Women who are unsure of their pregnancy status will be given a urine pregnancy test.
* Subjects taking investigational medications
* Subjects currently undergoing electroconvulsive therapy (ECT) or therapeutic transcranial magnetic stimulation (TMS).
* Subjects who regularly perform night or late evening shift work (e.g. - "second" or "third" shifts) or have had travel with time zone shifts \>3h in the last 3 weeks
Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.

After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age (by ultrasound).
* Evidence of a personally signed and dated informed consent/assent document. Assent will be obtained from subjects \<18 years of age.
* Subjects who are willing to and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Subjects who are available for follow up at delivery and on 28 days post delivery.

Exclusion Criteria:

* Age \<16 years old or \>35 years old.
* Multiple gestations as per the ultrasound at screening.
* Clinical symptoms of malaria.
* Hemoglobin \< 8 g/dL (at enrollment).
* Any condition requiring hospitalization at enrollment.
* History of convulsions, hypertension, diabetes or any other chronic illness that may adversely affect fetal growth and viability.
* Inability to tolerate oral treatment in tablet form.
* Known allergy to the study drugs (azithromycin, chloroquine, and sulfadoxine-pyrimethamine) or to any macrolides or sulphonamides.
* Requirement to use medication during the study that might interfere with the evaluation of the study drug eg, trimethoprim-sulfamethoxazole use in subjects positive for HIV infection.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
* Evidence of current obstetric complications that may adversely impact the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption.
* Known severe Sickle Cell (SS) disease or Sickle Hemoglobin C (SC) anemia.
* Known family history of prolonged QT Syndrome, serious ventricular arrhythmia, or sudden cardiac death.
Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD19 CAR-T cell in the treatment of recurrent or refractory B-ALL

The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

The Main research objectives:

To evaluate the safety and efficacy of 1904B in patients with recurrent or refractory B-ALL

The Secondary research objectives:

To investigate the cytokinetic characteristics of 1904B in patients with recurrent or refractory B-ALL

Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
2. A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation;
3. ECOG Scores: 0\~2
4. CD19 positivewere detected by immunohistochemistry or flow cytometry;
5. Estimated survival time\>3 months;
6. Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.

Exclusion Criteria:

1. Serious cardiac insufficiency；
2. Has a history of severe pulmonary function damaging;
3. With other tumors which is/are in advanced malignant and has/have systemic metastasis;
4. Severe or persistent infection that cannot be effectively controlled；
5. Merging severe autoimmune diseases or immunodeficiency disease;
6. Patients with active hepatitis B or hepatitis C(\[HBVDNA+\]or \[HCVRNA+\]);
7. Patients with HIV infection or syphilis infection;
8. Has a history of serious allergies on Biological products (including antibiotics);
9. Being pregnant and lactating or having pregnancy within 12 months;
10. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
MRI Perfusion Curves Typology and Orbital Tumors (PERFORM)

Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation.

Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers.

The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients.

For salivary glands, MRI allows to identify 4 different types of MRI characteristics, one (type C) being related to malignant tumors.

In this study, the investigators will try to see if extrapolation of those data to orbiltal tumors is feasible.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or more
* with orbital mass for which a biopsy and/or a surgical removal is planned
* undergoing an MRI
* before surgery

Exclusion Criteria:

* contra-indication to MRI
* intolerance to constrast agent
* pregnancy
* breast feeding
* patient under a legal protection procedure
* patient denying to participate to the study
* lack of affiliation to a social security system
A Study to Evaluate the Effect of Far Infrared Radiation for Cancer Treatment

Cancer is the number one killer in Canada and in most countries of the world. The investigators' initial assessment indicates that far infrared radiation has the potential to cure cancer.

The investigators have identified a combination of methods for possible cancer treatment as follows:

1. Energy specific far infrared radiation (5 μm to 20 μm ). No x-rays, gamma rays etc. are used.
2. Oxygenation of the body cells
3. pH balance
4. Lifestyle changes, or
5. A combination of chemotherapy and (1), (2), (3) and (4) above.

Eligibility Criteria:
Inclusion Criteria:

* All cancer patients

Exclusion Criteria:

* non-cancer patients
OPTAMI (Optimized Therapy of Acute Myocardial Infarction) - Registry

OPTAMI documents the characteristics of consecutive patients with acute STEMI and NSTEMI in hospital everyday-life in Germany, their acute and adjuvant medication treatment, events until discharge (e.g. mortality, stroke, re-MI), and their medication for secondary prevention at discharge.

In the follow up-period of one year, information is collected concerning events as mortality, stroke, re-MI, coronary interventions (PCI, CABG) and re-hospitalisation.

The implementation of guideline-adjusted therapy in hospital everyday-life is reviewed. The usefulness of the European standard for data acquisition in cardiology (CARDS = Cardiology Audit and Registration Standards) is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to hospital with an acute ST-Elevation myocardial infarction or with an acute Non-ST-Elevation myocardial infarction, both not older than 24 h

Exclusion Criteria:

* missing informed consent
Effects of Combined Robot-assisted Therapy With Mirror Priming in Stroke Patients

The purpose of this study is to examine the effects of combining robotic-assisted training and mirror therapy on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in stroke patients.

Based on trigger theory, this study designed a combining robotic-assisted training and mirror therapy. Before robotic-assisted training, a mirror therapy is performed to double the healing effect of robotic-assisted training.

This study hypothesized that combining robotic-assisted training and mirror therapy can improve the performance of hand function in stroke patients and promote daily life function, quality of life, and self-efficacy compared to single machine-assisted therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Brain injury more than 3 months.
2. Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
3. The myoelectric signal can be detected to activate the instrument
4. unilateral paresis (FMA score\<60)
5. no serious cognitive impairment (i.e., Mini Mental State Exam score \> 24)
6. can provide informed consent

Exclusion Criteria:

1. Other neurological disease
2. Complete sense of body defect
3. Inability to understand instructions
4. current participation in any other research
5. Botulinum Toxin injection within 3 months
Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy

This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
* Must have received any chemotherapy regimen in the past
* Evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
* Must have measurable (by imaging techniques) disease
* Adequate bone marrow, liver and renal function
* Must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.

Exclusion Criteria:

* Received more than 2 prior chemotherapy regimens for metastatic disease
* Received in the past another drug of the same class as the investigational drug, i.e. topoisomerase I inhibitor
* Enrolled in another clinical intervention study
* Pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
* Cardiac or thrombotic event in the last 12 months
* Brain metastases
The Relationship Between Anticholinergic Burden and Postoperative Complications After Cardiac Surgery in Older Adults

Drugs with anticholinergic properties are widely prescribed in the elderly population, despite increasing evidence in the literature regarding side effects and adverse outcomes. As is known, many drugs have anticholinergic activity, which means that they block the binding of the neurotransmitter acetylcholine to the muscarinic receptor. In this case, the occurrence of anticholinergic side effects becomes inevitable. Central effects such as cognitive impairment, dizziness, sedation, confusion or delirium, and peripheral effects such as dry mouth, dry eyes, constipation, urinary retention, and tachycardia begin to be seen in patients. Anticholinergic load refers to the cumulative effect of taking one or more drugs with anticholinergic activity. This cumulative effect is a strong indicator of cognitive and physical deterioration, especially in the elderly population. It is also associated with adverse outcomes such as falls, impaired functioning, and higher rates of hospitalization and death.

Anticholinergic load scales include scales that facilitate the work of physicians used in clinical practice to predict anticholinergic side effects in humans. Although there are many different scales used at this point, one of the scales with the highest validity and reliability in recent studies are Anticholinergic cognitive burden scale (ACB) and Anticholinergic risk scale (ARS). To the best of our knowledge, we could not find any study on postoperative complications, length of hospital stay and mortality after cardiac surgery with these scales. Therefore, we aimed to examine the relationship between possible complications after cardiac surgery and anticholinergic load scales showing the cumulative effect of preoperative drugs.


Eligibility Criteria:
Inclusion Criteria:

* It is planned to include patients over the age of 65 who underwent cardiac surgery in the research population.
* Gender discrimination will not be considered.

Exclusion Criteria:

* Those who are under the age of 65,
* Those who have non-cardiac surgery,
* Those whose drug records cannot be accessed
Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma

This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial asthma that is poorly controlled with the current standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with asthma \>1 year duration diagnosed according to the GINA guidelines (GINA 2010).
* Daily treatment with \> 1000μg beclomethasone dipropionate or equivalent, plus a long acting beta agonist for ≥ 3 months prior to Day 1, that has been stable for at least 4 weeks prior to screening.
* Asthma which is not adequately controlled on current treatment
* Peripheral blood eosinophil count \< 400/μl at screening

Exclusion Criteria:

* Women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
* Use of other investigational drugs at the time of screening, or within 30 days of screening.
* Smokers
Feasibility Study: Educational Genetic Test Video

Assess whether introducing an educational video regarding the benefits, risks, and limitations of genetic testing affects prostate cancer patients' decisional conflict regarding receiving germline genetic testing.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients who have been prescribed germline genetic testing by their provider
* Understand written and spoken English
* Have not received germline genetic testing for hereditary cancer risk in the past

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant individuals
* Prisoners
BHB & CAR-T for Lymphomas

The aim of this study is to assess the feasibility of β-hydroxybutyrate (BHB) supplementation in individuals who are receiving therapy for lymphoma with standard-of-care anti-CD19 CAR T-cells (CAR-T) to determine whether BHB supplementation is safe and tolerable in this patient population. Additionally, this study will determine whether BHB supplementation leads to changes the gut microbiome and peripheral blood mononuclear cells (PBMCs). BHB supplementation will be performed through oral administration of HVMN Ketone-IQ, a commercially available BHB supplement, with an active ingredient of R- 1,3-Butanediol, which is converted to BHB.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* History of pathologically-confirmed large B-cell lymphoma (LBCL)
* Planned treatment with a commercially available anti-CD19 CAR-T product (Yescarta or Kymriah)
* Eligible for and with adequate organ function (investigator discretion) and performance status (ECOG PS 2 or less) for standard of care, anti-CD19 CAR-T
* Not enrolled on a clinical trial of bridging therapy prior to CAR-T
* Patients must have a PET/CT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesions or ≥ 1cm for extra- nodal lesions in largest dimension by low-dose computerized tomography \[CT\] scan with FDG-uptake ≥ liver) documented prior to leukapheresis for CAR-T manufacturing
* Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator
* Can provide informed consent
* Willing to comply with all study procedures and available for the duration of the study

Exclusion Criteria:

* Subject is pregnant or breast feeding
* History of allergy to energy drinks
* History of inflammatory bowel disease
* History of type 1 diabetes mellitus or requirement for insulin
* History of chronic kidney disease with an eGFR \< 30 mL/min/1.73m2
* Additional second primary malignancy for which the subject is receiving active therapy or that will impede the ability of the investigator to assess lymphoma response
QXZS in Menopausal Syndrome Based on 16S rRNA Sequencing Technology

The goal of this clinical trial is to explore the differences of intestinal flora and saliva flora between menopausal women, and the changes after medication, to find the association between the two and menopausal syndrome. The main questions it aims to answer are:

* What are the differences in intestinal flora and saliva flora in menopausal women with hot flashes and sweating.
* Whether these differences change after using traditional Chinese medicine and the association between intestinal, salivary flora and menopausal syndrome.

  60 patients will be screened according to the clinical experimental criteria. They will be randomly divided into trial group (30 cases) and control group (30 cases). The test group takes traditional Chinese medicine Qingxin Zishen decoction, and the control group takes oral Femoston, comparing the two groups with analysis of symptom improvement, intestinal flora and salivary flora with 16S rRNA sequencing technology.


Eligibility Criteria:
Inclusion Criteria:

* Those who meet the diagnostic criteria for menopausal syndrome and the TCM heart and kidney syndrome differentiation criteria.
* Women between the ages of 45\~55.
* The score of the modified Kupperman Menopausal Symptom Rating Scale ≥ 15 points.
* Hot flashes and sweating≥ 3 times/day.
* Menopause ≥ 6 months.
* FSH \> 10U/L during menopausal transition, 40U/L \> after menopause, and estradiol (E2) \< (10\~20) pg/mL.

Informed consent, voluntary test. The process of obtaining informed consent should be in accordance with GCP regulations.

Exclusion Criteria:

* Other Chinese and Western drugs for the treatment of menopausal syndrome have been used after the onset of the disease.
* Have serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival.
* Contraindications to hormone therapy: known or suspected pregnancy; In perimenopausal women, menstrual disorders should be ruled out to exclude pregnancy-related problems such as intrauterine pregnancy, ectopic pregnancy, and trophoblastic disease. Unexplained vaginal bleeding: Causes of vaginal bleeding include neoplastic, inflammatory, iatrogenic, traumatic, and ovarian dysfunction, which should be carefully identified before perimenopausal menstrual disorders are treated with sex hormones. Known or suspected breast cancer. Known or suspected sex hormone-dependent malignancy. Active venous or arterial thromboembolic disease within the last 6 months. Severe hepatic and renal insufficiency.
* Those who are unable to give full informed consent due to intellectual or behavioral disabilities.
* Suspected or confirmed history of alcohol and drug abuse.
* Allergies, such as a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients of this medicine.
* Patients who are participating in clinical trials of other drugs.
Michigan Emergency Department Improvement Collaborative (MEDIC) Alert; Pulmonary Embolism (PE)

This study is a quality improvement project to evaluate health care management of pulmonary embolism (PE) patients. The researchers are testing an intervention to determine if it prevents unnecessary hospital admissions.

The study team anticipates that there will be 5800 acute PE patients over multiple sites.

Eligibility Criteria:
Inclusion Criteria:

* Participation in MEDIC collaborative
* Identified site physician champion
* Annual volume of acute PE ≥80 (measured in 2022)

Exclusion Criteria:

* Pediatric-only hospital/ED
* No site physician champion identified
* Annual volume of acute PE \<80 (measured in 2022)
* Existing formal clinical pathway for outpatient management of low-risk PE