cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Response to Hypoxia at Rest and During Exercise in a Healthy Subject After a Cryostimulation Exposure

Many information is available regarding human adaptations to cold or hypoxia. Adaptations to these environments and physical exercise constitute responses to physiological stress aimed at amplifying the organism's reactions and improving its performance. However, studies conducted so far to understand these adaptations and their underlying mechanisms have been organized in a dissociated manner, with each study focusing on only one of these specific situations (cold, hypoxia, or exercise). Understanding cross-adaptations is crucial, as human beings are often simultaneously exposed to several of these stimuli, and understanding this cross-exposure can be considered a prerequisite for pre-acclimatization strategies to these different environments.

Cross-adaptations has been defined as follows: "It simply involves considering that long-term exposure (either continuous or intermittent) to a given unfavorable environment not only increases tolerance to that particular environment but also leads to gains or losses of tolerance to other unfavorable factors that the adapted organism had never encountered before." When specifically examining cross-adaptations to cold and hypoxia, only one study focusing on the human model is available. The lack of perspectives and positions regarding the results calls for further investigations.

The main objective of this study is to assess the effect of repeated exposures to cryostimulation on the variation of the respiratory exchange ratio in hypoxia during exercise.


Eligibility Criteria:
Inclusion Criteria:

* Having a high level of physical activity according to the criteria of the World Health Organization, assessed using the Global Physical Activity Questionnaire (GPAQ);
* No exposure to cryostimulation or hypoxia (FiO2 13.5%, equivalent to an altitude of 3500 m) in the last 90 days;
* No planned sports competition during the 4 weeks of the protocol;
* Maintaining a stable physical activity level (regular training, without interruption or specific competition, including sports training programs) anticipated for 4 weeks;
* No history of respiratory conditions (asthma, respiratory allergies, exercise-induced asthma, exertional dyspnea);
* Absence of any chronic medical condition;
* No ongoing medication treatments;
* Covered by a French Social Security;
* Informed consent, signed by the subject after clear and fair information about the study.

Exclusion Criteria:

* Subject under treatment;
* Simultaneous participation in another clinical research study;
* Individuals with enhanced protection, namely minors, individuals deprived of liberty by judicial or administrative decision, persons staying in a healthcare or social facility, adults under legal protection, and finally, patients in emergency situations;
* Subject presenting a contraindication to hypoxia and/or cryostimulation.
Therapist-Guided Smartphone-Delivered CBT for MDD

We are testing a smartphone app that provides therapy for depression. Participants will also receive short weekly virtual appointments with a therapist. Researchers want to know if this new treatment is usable, whether participants are satisfied with it, and whether it can help lower symptoms.

The purpose of this project is to conduct an open trial to test the feasibility, acceptability, and preliminary efficacy of a new therapist-guided smartphone-delivered cognitive behavioral therapy (CBT) for major depressive disorder (MDD). This treatment will include unlimited access to the mobile CBT for depression app over 8 weeks plus 8 virtual visits with a doctoral-level psychologist or psychology intern with their master's degree. The therapist will be assigned once eligibility is determined. All virtual sessions will be no longer than 16-25 min. The combined CBT app plus virtual treatment will be tested in 28 patients. Clinical assessments will occur at baseline, mid-treatment (week 4), end-of-treatment (week 8), and 3 month follow-up. The investigators hypothesize that this treatment will be feasible, acceptable to participants, and lead to reductions in depression symptoms and functional impairment as well as improvements in quality of life from baseline to end-of-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Living in Massachusetts
* Current primary diagnosis of depression
* at least moderately severe current symptoms of depression

Exclusion Criteria:

* Recent or anticipated changes in psychotropic medication use
* Past participation in a course of CBT for depression
* Current severe substance use disorder
* Lifetime bipolar disorder or psychosis
* Acute, active suicidal ideation
* Concurrent psychological treatment
* Does not own a supported mobile Smartphone with a data plan
* Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Inflammation and Metabolic Acidosis at Birth (AGAIN: AutophaGy AcIdosis Newborn)

Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Neonatal encephalopathy (NE) occurs in 1.8 to 7.7 infants per 1000 births. Over the last six years, several randomized control trials have demonstrated that therapeutic hypothermia reduces the rate of death or disability at 18 months of age among infants who survived. However, the neurodevelopmental outcome in milder NE not treated with hypothermia remains unclear.

A multicenter prospective observational study will be conducted to determine biological changes of mild neonatal encephalopathy who are not recruited for therapeutic hypothermia .

It is a prospective observational multicenter study on 50 newborns with mild neonatal encephalopathy and metabolic acidosis at birth not qualified for therapeutic hypothermia compared to healthy controls.

Infants with metabolic acidosis at birth and evidence of mild encephalopathy graded according to Sarnat\&Sarnat neurological evaluation will be recruited to evaluate plasma concentration of melatonin and levels of Autophagy, mitophagy and inflammation.

Plasmatic changes will be compared to:

* healthy control
* infants with isolated metabolic acidosis at birth and normal neurological evaluation.

Eligibility Criteria:
Inclusion Criteria:

* gestational age \> 35 weeks and weight \> 1800 gr
* Apgar score \< 5 at 10 minutes o need for cardiopulmonary resuscitation at 10 minutes or evidence of base excess \> 12 mmol/L or pH \< 7,0 at initial blood gas analyses
* evidence of mild encephalopathy graded according to Sarnat\&Sarnat neurological evaluation
* normal amplitude integrated electroencephalography

Exclusion Criteria:

* suspected inborn errors of metabolism
* major chromosomal congenital defects
Chiropractic Manipulation and Medical Care for Low Back Pain

The investigators will be comparing the effectiveness of two types of chiropractic manipulation and standard medical care for patients with a recent onset of low back pain. The two types of chiropractic treatments being compared will be hands-on (manual) manipulation and mechanical-assisted (Activator) manipulation. The standard medical care will consist of a medical examination and prescription for over-the-counter anti-inflammatory medication.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years of age
* Ability to read and write English
* Experiencing a new episode of low back pain (LBP) with onset in the past 3 months
* Oswestry Disability Index score between 20-70 points (0-100 scale)
* Numeric pain rating score between 3-8 points (0-10 scale)

Exclusion Criteria:

* Prior history of lumbar spine surgery
* History of unstable spondylolisthesis, spinal stenosis, or scoliosis \> 20°
* Signs or symptoms suggestive of nerve root tension and/or neurological deficit in the lower extremity
* History of metastatic cancer, osteoporosis, long-term corticosteroid use, or any other red flags of serious illness including the following: unexplained weight loss of \>10% of body weight, spinal pain associated with fever, and severe night pain unrelieved by medication
* Receiving any physical therapy, chiropractic therapy, or any other manual therapy for this episode of LBP (within the past 3 months)
* Receiving any on-going medical care for this episode of low back pain
* Current use of opiate or other prescription medications for low back pain
Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women

Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening.


Eligibility Criteria:
Inclusion Criteria:

* women from 30 to 65 years old
* women living in french territorial division 37 ("Indre-et-Loire")
* women having a reported general practitioner in french territorial division 37 ("Indre-et-Loire")

Exclusion Criteria:

* pap smear made in the three last years
Refractive Accuracy of Argos in Conjunction With the Alcon Vision Suite Following Implantation of Presbyopia Correcting IOLs

The objective is to assess refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation.

This study is a single-arm, observational study of refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation. Subjects will be assessed at preoperatively, operatively, and 10 weeks post-operatively. Clinical evaluations will include measurement of monocular and binocular visual acuity, manifest refraction, and questionnaires will also be administered.

Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Age-related cataract surgery (or RLE) patients that select Clareon PanOptix or AcrySof Vivity IOL.
* Gender: Males and Females.
* Age: 45 or older.
* Patients motivated to increase spectacle independence with relatively low incidence of visual phenomena.
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error).

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Ocular comorbidity (any previous ocular surgery, any signs of retinal disease, or glaucoma etc.) that might hamper post-operative visual acuity.
* Irregular corneal astigmatism and keratoconus.
* Post refractive eyes (i.e. LASIK or PRK or SMILE).
* Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
* Angle Kappa/chord mu ≥0.6.
* Higher order corneal aberrations: \> 0.6 total RMS, \>0.3 coma, \>0.3 trefoil (to exclude irregular corneas).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
rTMS for Orthopaedic Trauma Patients

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for orthopaedic trauma patients. In this open label study, all participants will receive accelerated theta-burst stimulation. This study will examine whether symptoms of psychiatric distress and opioid use in orthopaedic trauma patients can be mitigated with rTMS to improve post-injury recovery.

A large percentage of orthopaedic trauma patients suffer from psychiatric distress and chronic pain related to their injury and underlying psychosocial factors; this predicts poor post-injury recovery.

Repetitive transcranial magnetic stimulation (rTMS) is a neuromodulation technique used to stimulate areas of the brain that may modulate symptoms of pain, depression, and post-traumatic stress. The FDA-approved rTMS protocol for treatment is 10Hz stimulation for 40 minutes over the left dorsolateral prefrontal cortex (L-DLPFC) for the treatment of depression. This methodology has been very successful in real world situations, however poses some limitations, including the duration of the treatment session (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study will use modified parameters to create a more rapid form of treatment and look at outcome changes in pain and depression, commonly seen in orthopaedic trauma patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 65 years of age.
* Able to provide informed consent.
* Present to Stanford Emergency Department as a trauma with a major operative lower extremity injury
* Glasgow coma scale of 15 within 24 hours after admission or extubation
* Negative urinary toxicology screen for illicit substances;
* Negative pregnancy test if female and less then 60 y/o;
* No suspicion for a head injury and/or negative head CT scan for intracranial hemorrhage or injury based on standard of care
* No history of seizure disorder or other neurological disorders.
* All patients included must screen positive for PHQ-9 score \>4 (positive symptoms of depression) and CES-T score \<36 (poor coping self-efficacy).

Exclusion Criteria:

* Incarceration,
* Pregnant females,
* Prior psychotic disorder,
* Current use of anti-depressant or anti-psychotic medications,
* Prior-admission opioid use within 30 days (patients will be screened for recent prescription opioid use using the CURES report),
* Heavy alcohol use,
* Lesional neurological disorder or brain implant or intracranial ferromagnetic material,
* Seizure disorder
Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

DanshenDuofensuanyan is kind of Chinese Medicine injection used for treating coronary heart disease and angina pectoris in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for DanshenDuofensuanyan injection safety surveillance with 30000 patients will be conducted from Jan.2013 to Dec.2015.

Eligibility criteria Patients who will use DanshenDuofensuanyan injection in selected hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Patients using DanshenDuofensuanyan injection from 2013 to 2014

Exclusion Criteria:

* none
Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study

This is a national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates).


Eligibility Criteria:
Inclusion Criteria:

* Patient with an anterior cruciate ligament (ACL) revision, defined as "all surgical procedures involving replacement of the anterior cruciate ligament (ACL) graft with a new graft".

Exclusion Criteria:

* multil-igament injuries
* any procedure where the ACL was not revised and where any additional graft was inserted
* Patients who had already undergone their first revision anterior cruciate ligament (ACL) procedure
Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia

RATIONALE: Vaccines made from a person's white blood cells and cancer cells may make the body build an effective immune response to kill cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with acute myeloid leukemia.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of autologous dendritic and leukemic fusion cell vaccine in patients with acute myeloid leukemia.
* Determine the toxicity of this vaccine in these patients.

Secondary

* Determine whether cellular immunity can be induced by this vaccine in these patients.

OUTLINE: This is a dose-escalation study.

At the time of diagnosis, patients undergo tumor cell harvest. Patients also undergo bone marrow aspiration to collect mononuclear cells to obtain dendritic cells (DC). If insufficient DCs are obtained, patients undergo leukapheresis to obtain a sufficient number of peripheral blood mononuclear cells (PBMC). The PBMC are treated in the laboratory with sargramostim (GM-CSF) and interleukin-4 for 5-7 days to produce DC. Leukemic blasts are fused to DC to generate the dendritic/leukemic fusion cell vaccine.

Patients then undergo standard induction chemotherapy to obtain a remission, followed by standard consolidation chemotherapy.

After completing consolidation chemotherapy, patients receive autologous dendritic and leukemic fusion cell vaccine subcutaneously every 2 weeks for a total of 4 doses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3 patients receive escalating doses of autologous dendritic and leukemic fusion cell vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 3-9 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia (AML) by bone marrow biopsy

  * Newly diagnosed
* Must have adequate dendritic cells and AML blasts isolated from bone marrow and/or peripheral blood
* No clinical evidence of CNS leukemia

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No clinically significant autoimmune disease
* No other active malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* More than 3 months since prior immunotherapy

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Smartphone Message to Improve the Drug Compliance in Pregnant Women.

As technology advances, smartphones are now widely available and can provide a convenient and effective means to improve drug compliance by sending an electronic reminder on a regular basis. In a meta-analysis of 16 RCTs in assessing of drug compliance in chronic diseases, text message significantly improves medication compliance (OR, 2.11; 95% CI, 1.52-2.93; P \< 0.001). The drug compliance improves from 50% to 67.8%, or an absolute increase of 17.8%. Further evaluation is required as most of these RCTs relies on self-reported compliance. This data may be not applicable to pregnant women and trial of using this approach to improve drug compliance during pregnancy is lacking.

The investigators hypothesize that the use of smartphone message will improve the drug compliance in pregnant women requiring long term medications. The investigators propose a randomized controlled trial to evaluate the effect of smartphone message.


Eligibility Criteria:
Inclusion Criteria:

* All women age ≥ 18 years old
* Able to receive electronic reminder through smartphohne
* Gestational age less than 16 completed weeks as defined by pelvic ultrasound
* Part 1: Need to take aspirin or progesterone for prevention of pre-eclampsia or preterm birth respectively
* Part 2: Given multivitamin as health supplementation

Exclusion Criteria:

For Part 1:

* History of adverse reaction to aspirin
* History of adverse reaction to progesterone
* History of breast or genital tract malignancy
* History of suspected thromboembolic disease
* Congenital uterine anomaly
* Unwillingness or inability to comply with study procedures
* Known paternal or maternal abnormal karyotype
Study to Evaluate DNL151 in Subjects With Parkinson's Disease

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL151 in subjects with Parkinson's disease.

This study was previously posted by Denali Therapeutics. In July, 2022, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) between 18 and 35.0 kg/m2, inclusive
* Clinical diagnosis of Parkinson's disease meeting UK Brain Bank criteria and H\&Y Stage I, II, or III.
* Able to hold Parkinson's disease medications 8 hours (overnight) prior to specific study assessments

Key Exclusion Criteria:

* Any history of clinically significant asthma, chronic obstructive pulmonary disease, or emphysema within 5 years of screening, or other clinically significant pulmonary disease within 6 months of screening
* Abnormal Vitals including Respiratory Rate, Body Temperature, Blood Pressure, and Pulse Rate
* Pulmonary Function Tests (PFTs) (FVC \<60% predicted, FEV1 \<50% predicted, FEV1:FVC ratio \<0.6, DLCO \<70% predicted)
* Clinically significant neurologic disorder other than Parkinson's disease, including history of stroke within 12 months of screening, cognitive impairment, seizure within 5 years of screening, or head trauma with loss of consciousness within 6 months of screening
* Montreal Cognitive Assessment (MoCA) score of \<24 at screening

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply