cyrilzakka/clinical-trials huggingface dataset:
Exploring the Modulatory Role of Sex Hormones Along the Neuromechanical Axis in Females

The goal of this project is to test our central hypothesis that changes in sex hormone concentration result in changes to the basic elements of motor control - at multiple levels, from the musculotendinous unit to motor control circuitry. Under Aim 1 the investigator will determine the influence of sex hormone fluctuations on the muscle stretch reflex during active and passive states, and the time lag between hormone concentration changes and the reflex response. The investigator will use a technically simple assessment that could be implemented in the field. Under Aim 2 the investigator will determine the influence of sex hormone fluctuations on spinal motor neuron excitability using H-reflex as a probe and the simultaneous change in the muscle mechanics using muscle twitch response. Aims 1 \& 2 will include a focus on the differential role of oral contraceptives. In Aim 3 the investigator will use paired-pulse transcranial magnetic stimulation during active contraction to determine the influence of sex hormone fluctuation.


Eligibility Criteria:
Inclusion Criteria:

* Females: ages 18-39 years, who are eumenorrheic (regular monthly cycles of 24-35 days) or on a stable hormonal contraceptive regimen for 6 months (oral, transdermal or vaginal), no history of pregnancy, moderately active (less than 7 hours of vigorous physical activity per week)
* Males: Ages 18-39

Exclusion Criteria:

* History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot, history of neurological injury of the peripheral or central nervous system, current smoker, history of disordered eating, history of stress fracture in the lower limb, history of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease).
* For female participants only: Point of care screening for anemia will be completed, and individuals with hemoglobin levels \<11.6 g/dl will be excluded from participating in the study.
* Specific exclusion criteria for TMS (male and female): pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold, and pregnancy.
* Additional exclusion criteria for female participants: History of menstrual dysfunction (primary or secondary amenorrhea, oligomenorrhea, anovulatory cycles, polycystic ovarian disease), current or past pregnancy, started or stopped taking oral contraceptives within the previous 6 months, exercise vigorously more than 7 hours per week or currently participating in competitive level sports. The reason for excluding highly active or competitive athletes is due to the high rate of undiagnosed menstrual dysfunction in females of this population.
* This study will not include: adults unable to consent, Individuals who are not yet adults (infants, children, teenagers), pregnant women or prisoners.
Pharmacokinetics Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.

This is a multi-center, open-label, randomized study. Participants will be assigned to A or B groups with a scale of 1:1 , i.e. infuse study drug followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the study will enter the Prophylactic Therapy Study.


Eligibility Criteria:
Inclusion Criteria:

1. Hemophilia A.
2. FVIII:C \<1%. 3）12 and 65 years old.

4）Has received FVIII treatment and the treatment exposure days ≥100. 5）Has bleeding treatment records of at least 3 months before randomization. 6）FVIII inhibitor assay results is negative.

7） Subjects should agree to use an adequate method of contraception during the study.

8）Understood and Signed an informed consent form. 9）Has not received an treatment of any FVIII within 4 days before the first dose.

10）Non-bleeding state.

Exclusion Criteria:

1. Has a history or family history of blood coagulation factor VIII inhibitor.
2. Has other coagulation dysfunction diseases in addition to hemophilia A.
3. HIV positive.
4. Plan to receive surgery during the trial.
5. Has used immunomodulator within one weeks before the first dose，and less than 7 half-life periods.
6. Known to be allergic to experimental drugs or any excipients.
7. Severe anemia and need blood transfusion.
8. Serious liver or kidney damage.
9. Serious heart disease.
10. Uncontrollable hypertension.
11. Has participated in other clinical studies within one month before the first dose.
12. The researchers believe that it is not suitable for participants.
Quick Returns - Sleep, Cognitive Functions and Individual Differences

The project will contribute with new knowledge concerning how short rest periods between two consecutive shifts (\<11h, often defined as a Quick Return (QR)) affects sleep and cognitive performance. The study will further examine whether individual differences in personality traits and genotypes may explain individual differences in performance and sleep. Data will be collected with a randomized cross-over design, in an experimental laboratory setting.

Rotating shift workers may have a narrow time window to rest after an evening shift, before returning early to work for a day shift. In the literature, a rest opportunity of less than 11 hours between two consecutive shifts, is defined as a Quick Return (QR). Most often, this is occurs when working an evening shift followed by a day shift. Survey- and longitudinal studies have found associations between QRs and an increased risk of being involved in occupational accidents. However, no studies have experimentally investigated how a QR scenario may affect performance at work and sleep between the two shifts. Thus, the project will experimentally simulate QRs, where a battery of cognitive tests will be administered in a laboratory to indicate performance. Objective and subjective sleep will be measured/reported at home where participants normally sleep. Additionally, genotype- and personality trait data will be collected and used as moderators in the analyses.

A randomized cross-over design with two groups will be applied. In one condition, participants will work an evening shift (03:00PM-11:00PM) followed by a day shift (07:00AM-03:00PM, QR). In the other condition, participants work a day shift (07:00AM-03:00PM) followed by another day shift. Four weeks later after being in one of the conditions, the participants will return to the laboratory and work in the opposite condition. Sleep will be subjectively reported with a sleep diary and objectively measured using a low-powered ultra-wideband radar, two days before and between the two simulated shifts in each of the two conditions.

Eligibility Criteria:
Inclusion Criteria:

* Participants are physically and mentally healthy (assessed with BMI and 'General Health Questionnaire-12)'.
* Participants accept to comply to the protocol (retain regular bed- and wake times before the simulated shifts).
* Refrain from alcohol and maintain regular nicotine and caffeine usage during participation.
* Norwegian as primary language/proficiency in Norwegian language.

Exclusion Criteria:

* Neurological, psychiatric or sleep related disorders ('Bergen Insomnia Scale, 'Global sleep assessment questionnaire').
* Extreme 'morning-eveningness' type ('Horne-Östberg).
* Use of medication that affect sleep or cognitive performance.
* Pregnancy.
Diagnosis of Bone Metastases in Breast Cancer: Bone Scintigraphy, Fluoride-PET and FDG-PET

Breast cancer can metastasize to the bones, which leads to another treatment if bone metastases are detected. The purpose of the study is to determine, if fluoride PET/CT is superior to bone scintigraphy with technetium. On the other side, the investigators would like to see if FDG-PET/CT is a reliable alternative to dedicated bone imaging to detect bone metastases in patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven c. mammae
* clinically suspicion of bone metastases

Exclusion Criteria:

* age under 18 years
* diabetes mellitus
* pregnancy
* other known malignant disease
Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses

This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study.

The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the scalp on treated areas
* Subject with two symmetrical treated areas half scalps or two half faces excluding ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no more than a twofold difference in terms of total number of lesions between the two TAs

Exclusion Criteria:

* Subject with clinical diagnosis of at least one severe (Grade 3) AK on treated areas
* Subject with pigmented AK on the treated areas
* Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons
* Subject with porphyria,
Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.

Study participants will be administered a 3-dose regimen of 9vHPV. They will be assessed for immunogenicity 1 month following completion of vaccination. All participants will be followed for safety for a total of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Good physical health
* Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
* Other inclusion criteria will be discussed with the investigator

Exclusion Criteria:

* History of severe allergic reaction that required medical intervention
* Currently enrolled in a clinical trial
* If participant is female, pregnant
* Currently immunocompromised or having received immunosuppressive therapy in the last year
* Positive test for HPV
* History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer
* If participant is female, history of abnormal cervical biopsy results
* Other exclusion criteria will be discussed with the investigator
Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

This is a multicenter, open-label, phase I/II clinical study, to assess the safety, tolerability, antitumor activity, pharmacokinetics and pharmacodynamics of EOS884448 (also known as EOS-448 or GSK4428859A), alone or in combination with iberdomide with and without dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM).


Eligibility Criteria:
Inclusion Criteria:

* All participants must have a documented diagnosis of relapse/refractory Multiple Myeloma and have measurable disease as defined per IMWG criteria.
* All participants must have received at least 3 prior lines of MM therapy with IMiD, PI and Anti-CD-38, and progressed on their last therapy (prior BCMA targeted therapy allowed).
* All participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1or 2.
* All participants must have adequate organ function.
* Females of childbearing potential (FCBP) or male participant must agree to follow contraception requirements.

Exclusion Criteria:

* All participants with non-secretory MM
* All participants with known auto-immune disease
* All participants with history of life-threatening toxicity related to prior immune therapy.
* All participants with active graft versus host disease after allogeneic stem cell transplantation.
* All participants with active, unstable cardiovascular function.
* All participants with active infection requiring systemic therapy.
* All participants with hypersensitivity to any of the treatments.
* All participants with any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment.
Misoprostol for the Treatment of Postpartum Hemorrhage

The purpose of this study is to test whether misoprostol is as effective as oxytocin for treating primary postpartum hemorrhage (PPH) with uterine atony as the suspected cause in two circumstances: 1) where women have received prophylactic uterotonics in the third stage of labor; and 2) where no prophylactic uterotonics have been given in the third stage of labor.

Postpartum hemorrhage (PPH) remains a major cause of maternal deaths worldwide. Misoprostol offers several advantages over oxytocin and ergometrine, the drugs currently used to treat PPH. For example, misoprostol is stable at high temperatures and has a shelf life of several years, it is easy to administer, it can be given to hypertensive patients, and it is inexpensive. This randomized, double-blind placebo-controlled trial will test whether misoprostol is as effective as oxytocin in treating primary PPH in hospital births, both when women have received prophylactic uterotonics in the third stage of labor and when they have not.

Blood loss will be measured for all consenting women who deliver vaginally. If PPH occurs and uterine atony is the suspected cause, women will be randomized to receive either: a) four 200 µg pills of misoprostol sublingually and an IV of saline (resembling oxytocin) or b) four placebo tablets resembling misoprostol sublingually and 40 IU oxytocin by IV. This study seeks to answer the following questions:

* Is misoprostol as effective as oxytocin for treatment of primary PPH for women who do and do not receive oxytocin prophylaxis in the third stage of labor?
* Does misoprostol have an acceptable safety profile when given as an 800 µg sublingual dose to treat PPH?
* Is the side effect profile of misoprostol acceptable to women?

This study will take place in hospitals located in Burkina Faso, Ecuador, Egypt, Turkey, and Vietnam.

Eligibility Criteria:
Inclusion Criteria:

* Vaginal delivery
* Postpartum hemorrhage due to suspected uterine atony
* Depending on study group: administration of prophylactic uterotonics in third stage of labor

Exclusion Criteria:

* Known allergy to misoprostol or other prostaglandin
* C-section for current delivery
Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases

The purpose of this study was to determine the safety and therapeutic effect of sub-retinal transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in patients with macular degeneration diseases, and explore new treatment modalities for macular degeneration diseases (Age-related macular degeneration and Stargardt's macular dystrophy).


Eligibility Criteria:
Inclusion Criteria:

* Aging from 18 to 75 years
* must have signed informed consent
* At least one visually impaired eye caused by macular degeneration diseases
* Can not be effectively treated with conventional therapies
* Best corrected visual acuity scores between 19 and 73 letter in ETDRs (early treatment diabetic retinopathy ) eye chart , including 19 and 73 (or the equivalent of Snellen eyesight from 20/400 to 20/40)
* Visual loss caused by macular degeneration diseases

Exclusion Criteria:

* Eyes with concomitant diseases which will interfere the visual improvement of the study
* Active intraocular inflammation regardless of the grade of severity
* Active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, ophthalmia)
* History of uveitis
* Severe cataract, glaucoma, retinal blood vessels occlusion, retinal detachment, macular hole, vitreous-macula traction
* Iris neovascularization
* Patients who have only one functioning eye, or the best corrected vision of untreated eye scores less than 24 letters in ETDRS chart(corresponding to 20/320 in Snellen chart)
* History of intraocular surgery
* Severe systemic diseases: Stroke, coronary heart disease, angina pectoris, renal insufficiency needing dialysis
* Allergic to sodium fluorescein
* Uncontrolled hypertension (systolic pressure\>140mmHg,or diastolic pressure\>90mmHg)
* Coagulative function disorder
* System administration of drugs that are toxic to lens, retina, or optic nerve like hydroxychloroquine, phenothiazine, ethambutol, tamoxifen, etc.
* Involved in other clinical trials of any medicine within 1 month (or within 5 half-life periods)
* Have maternity plan in 6 months
* In pregnancy or lactation period.
Sleep Apnea in TIA/Stroke: Reducing Cardiovascular Risk With Positive Airway Pressure

The goal of this study is to develop a novel study design to safely and ethically conduct a long-term randomized controlled trial among patients at high risk for both sleep apnea and cardiovascular events that will examine whether effective positive airway pressure(PAP) therapy reduces cardiovascular risk. Patients with transient ischemic attack(TIA) or stroke have a high prevalence of sleep apnea(60-80%), and they are at high risk of cardiovascular events(myocardial infarction, congestive heart failure, recurrent stroke, and cardiovascular death)in the first year post event, despite current prevent strategies. Therefore, the treatment of sleep apnea may represent a novel therapeutic target to reduce cardiovascular outcomes in this high risk population.

The proposed study is a randomized controlled trial among patients with transient ischemic attack (TIA) and minor stroke, comparing strategies for the diagnosis and treatment of sleep apnea with usual care over 6-12 months at 2 sites (Yale University School of Medicine and Indiana University School of Medicine). Patients with TIA and minor stroke will be randomly assigned to either usual care or a diagnosis and treatment approach that includes ambulatory polysomnography and initiation of autotitrating CPAP for sleep apnea in a 1:2 (control:intervention) randomization scheme. Intervention patients with sleep apnea will receive either a standard CPAP treatment intervention or an enhanced protocol designed to increase long-term CPAP adherence. The primary outcomes will include: (a) the impact of CPAP on pathophysiologic markers in the following domains of cardiovascular risk: inflammation (CRP, Il-6), heightened sympathetic activity/parasympathetic withdrawal (plasma catecholamines and heart rate variability (HRV)), insulin resistance (HOMA-IR, HbA1C), endothelial injury (flow mediated vasodilation), and atherosclerosis (carotid intima-media thickness); and (b) long-term (6-12 month) CPAP adherence.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* TIA or ischemic stroke
* within 1 week of neurological symptom onset
* brain imaging within 24 hours

Exclusion Criteria:

* known to have sleep apnea
* suspected sleep disorder other than sleep apnea
* hospice patients or patients receiving comfort only measures
* patients unable to use a nasal or face mask
* patients who require mechanical ventilation
* Non English language patients
* inability to provide informed consent
* active suicidal ideation
* live outside the recruitment area
* provider does not allow researcher to contact patient
Evaluation of the Role of OCT in the Detection of HIV-associated Neurocognitive Disorder

The purpose of this study is to determine the sensitivity and specificity of the use of optical coherence tomography to detect HIV-associated neurocognitive disorder compared to MRI and usual cognitive screening tools.


Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Antiretroviral treatment
* Undetectable plasmatic HIV viral load (viral load\<50 copies/ml) for at least 6 months
* Ability to understand and give approved consent

Exclusion Criteria:

* Any present or past ophthalmologic illness that may impair OCT results
* Previous cerebral infection with sequel
* Previous cerebrovascular disease with sequel
* Severe psychiatric illness
* Active alcohol or drug abuse
* Active chronic hepatitis C
* Inability to perform french cognitive assessment
* Inability to perform a MRI
* Inability to perform a lumbar puncture
An Integration of Tai Chi and Repetitive Transcranial Magnetic Stimulation for Sleep Disturbance in Older Adults

The investigators designed an RCT aimed at 1) exploring the effectiveness of combining TC with rTMS for synergistically improving sleep disturbances in community-dwelling older adults, 2) investigating the mediating roles of arousal states as the underlying mechanism of the potential beneficial effects, and 3) evaluating the feasibility and safety to inform the clinical practice. The investigators hypothesized that integrating TC and rTMS can affect the different dimensions of the arousal system to improve sleep disturbances with optimized clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Classified with sleep disturbances (indications of poor sleep quality with a score \>5 in Pittsburgh Sleep Quality Index)
2. Education level at primary or higher, and able to communicate in Cantonese (3) No experience of mind-body exercising such as TC, Qigong, or yoga within the past 6 months

Exclusion Criteria:

1. Serious visual or hearing difficulty
2. Active suicidal ideation or self-harm behaviors
3. Cognitive impairment (a score \<26 in the Montreal Cognitive Assessment)
4. Comorbid diagnoses such as mental disorders, organic brain syndrome, or intellectual disabilities
5. Cardiac pacemaker, implanted medication pump, the intracranial implant (e.g., aneurism clips, shunts, stimulators, cochlear implants, or electrodes), or any other metal object within or near the head
6. Receiving other treatments or participating in other clinical trials during the same period
7. Current severe medical condition preventing physical exercise
Radial Shock Waves for Functional Disability in Stroke

This is a double blind randomized clinical trial to evaluate the effect of radial shock waves on functional recovery of the upper limb of patients with sequelae of ischemic strokes in the territory of the middle cerebral artery. A total of 20 patients will be enrolled and will undergo motor, functional and cortical excitability evaluations before and after four weekly sessions of radial shockwaves. 5,000 pulses with a frequency of 15 Hz and 3.5 to 4 bar of air pressure will be applied to the active group, resulting in an energy flux density (EFD) of approximately 0.07 mJ/mm2. The sham group will receive identical treatment, except for the fact that no energy flux will be applied.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis: Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan indicating Stroke in the territory of the middle cerebral artery;
* 6 to 24 months after stroke date;
* Stability observed in clinical medical evaluation
* Granting of written informed consent to participate in the study

Exclusion Criteria:

* Individuals with a score lower than 24 on the Mini-mental test;
* Previously documented strokes
* Pregnancy
* Patients treated with botulinum toxin, phenol, alcohol or previous surgeries six months before entering the study
* Bone diseases, pre-existing joint damage, and deformities affecting the patient in a way to interfere with implementation of the proposed therapy
* Psycho-affective disorder that prevents adherence
* Joint pain that occurs within the movement range of therapies