cyrilzakka/clinical-trials huggingface dataset:
Community-based Brain Health Program to Address Dementia Risk

This is a validation study to evaluate the acceptability, feasibility and preliminary efficacy of the Brain Health Program, a multimodal curriculum covering dementia risk factors and evidence-based change interventions. The goal of this study is to evaluate the Brain Health Program in individuals with identified risk factors for the onset of dementia and to prepare for a large-scale efficacy trial in this population.

This study will employ an evidence-based Brain Health Program curriculum, which involves a twelve-week, group-administered, personalized program designed to improve brain health in individuals with identified risk factors for the onset of dementia. This is a single-arm open-label feasibility study, enrolling older adults with Alzheimer's disease risk factors in a public health, community-deployed, group-based and individualized multimodal Brain Health Program (targeting, among other domains, diet, exercise and cognitive exercise), with a set of baseline assessments intended to characterize the population, and outcome measure to evaluate the usability of the program, as well as preliminary efficacy to reduce dementia risk factors.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who are 65 years of age or older.
2. Participants who meet criteria for one or more ADRD dementia risk factors

   1. Family history of Alzheimer's dementia (1st degree relative)
   2. Genetic marker (APOE4++)
   3. Subjective or objective cognitive decline (neuropsychological testing; or self-reported "yes" to the following question: "In the past two years, have you experienced a decline in your memory or thinking?"
   4. Poorly controlled hypertension or diabetes
   5. Physical inactivity \<150min/week per Surgeon General guidelines
   6. Social isolation, in which participant rarely or never gets social and emotional support when needed
3. Participants who are fluent English or Spanish speakers, per self-report, to ensure reasonable neuropsychological results on key assessments.
4. Participants have access to an internet accessible device (eg. laptop, desktop computer, tablet or smartphone)
5. Participants are able to attend all 12 classes (once a week for 12 weeks) and make up missed classes, as needed
6. Participants are able to travel to/from YMCA location, if they choose to be a part of the in-person group

Exclusion Criteria:

1. Inability to provide informed consent
2. Cognitive Abilities Screening Instrument - Short (CASI-Short) scores ≤ 25 (suggestive of cognitive impairment)
3. Participants with untreated psychiatric conditions, including substance abuse/dependence disorders.
4. Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study. However, participation in standard treatments (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable.
5. Participants presently attending classes or courses like this program that is focused on dementia risk and behavior management.
Effects of One-to-one Service on the Continuation and Satisfaction of Contraceptive Use.

This study aims to explore the impact of a mobile based one-to-one service model on improving the continuation and satisfaction of combined injectable contraceptive use, and improve the utilization and acceptability of efficient and long-term contraceptive methods.

In China, due to the lack of understanding or misunderstanding of hormonal contraception by service providers and the public, the use of combined injectable contraceptive is not common. Therefore, this study aims to explore the impact of a mobile based one-to-one service model on improving the continuation and satisfaction of combined injectable contraceptive use, and improve the utilization and acceptability of efficient and long-term contraceptive methods.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 40 years old;
* Healthy Volunteers;
* More than 6 months after delivery and without lactation;
* No fertility intention within 6 months;
* Normal menstruation;
* No contraindications to the use of compound contraceptive methods;
* Had not used hormonal contraception in the previous three months;
* Understand the content and requirements of the project, be willing to cooperate, and have signed the informed consent form;
* Have a certian education level, and be able to use the special sanitary napkins to record menstrual volume and menstrual card.

Exclusion Criteria:

* Suffering from serious systemic diseases;
* Previous or current thrombotic disease;
* Malignant tumor of uterine organ;
* Unable to communicate normally due to disability or mental or intellectual impairment.
Barotrauma in Adults With Critical COVID-19

During the pandemic of COVID-19, studies reporting a high incidence of barotrauma, both pneumothorax but also pneumomediastinum, in patients with critical COVID-19. If this is complications of the respiratory support used to treat patients hypoxemia or if it is a direct consequence of COVID-19 damaging the lung tissue is not known.

The aim of this study is to investigate the incidence and type barotrauma, if there is an association between barotrauma and level of respiratory support used in the intensive care unit, and if barotrauma is associated with worse outcome compared to patients without barotrauma.


Eligibility Criteria:
Inclusion Criteria:

* Positive polymerase chain reaction for SARS-CoV-2
* Admitted to ICU due to respiratory failure

Exclusion Criteria:

* Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible
Research on the Impact of Chronic Pelvic Pain on Endometriosis

Chronic pelvic pain (CPP) is a common disease with multiple systems and multiple causes. In recent years, the incidence rate of CPP in women has gradually increased. It is a pain symptom that originates from pelvic organs or related structures and lasts for more than 6 months. It is closely related to gynecological diseases such as endometriosis (EMs), adenomyosis, pelvic inflammatory disease (PID), uterine leiomyoma, residual ovarian syndrome, pelvic venous congestion syndrome (PCS), etc. But its pathophysiology is very complex and still needs further exploration. Recent studies have shown that central sensitization is an important mechanism for the sustained existence of CPP.

Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as preoperative endometriosis related questionnaire surveys such as such as Endometriosis Health Profile-30 (EHP-30), Central Sensitivity Inventory (CSI), Simplified McGill Pain Questionnaire (SF-MPQ). Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as in vitro detection results such as preoperative venous blood, intraoperative pathological tissue immunohistochemistry, ELISA, transcriptome sequencing in patients with endometriosis.

Conduct preoperative and postoperative endometriosis related questionnaire surveys on patients, such as Endometriosis Health Profile-30 (EHP-30), Central Sensitivity Inventory (CSI), Simplified McGill Pain Questionnaire (SF-MPQ). Follow up will be conducted 1-2 months after surgery. Preoperative venous blood from patients with endometriosis and pathological tissue of endometriosis removed during surgery were collected for in vitro testing using immunohistochemistry, ELISA, transcriptome sequencing.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 years old;
* Endometriosis diagnosed through previous surgery (confirmed solely by visual or histopathological examination), endometriosis discovered through imaging examination, deep infiltrating nodules discovered through palpation or imaging examination, and clinically suspected endometriosis;
* No history of migraine or tension headaches;
* No history of mental illness (such as restless leg syndrome, chronic fatigue syndrome, fibromyalgia, anxiety or panic attacks, depression).

Exclusion Criteria:

* Postmenopausal state (spontaneous or surgical);
* Previous hysterectomy and/or bilateral salpingo oophorectomy (prior to preoperative visit);
* The patient or authorizer refuses.
Phase 1 Study of AWT020 in Advanced Cancer

The aims of this clinical trial are (1) to assess the safety of AWT020 at different dose levels; (2) to determine the pharmacokinetics and pharmacodynamics of AWT020 in subjects with locally advanced or metastatic cancer who have failed standard therapy.

This study will enroll subjects with locally advanced or metastatic cancer who have failed standard therapy. Subjects enrolled into this study will be assigned a dose level and receive AWT020 via intravenous infusion at a regular interval. The treatment will be continued until disease progression, withdrawal from study or death. The primary objective is to investigate the safety of this agent. The secondary objective is to investigate the pharmacokinetics, pharmacodynamic, potential anti-tumor activity and immunogenicity of this agent.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent prior to initiation of any study specific activities or procedures.
* Subject must be ≥ 18 years of age or per local regulation.
* Subjects must have a histological diagnosis of solid tumors (carcinoma or sarcoma) or malignant lymphoma, either progressive locally advanced not amenable to local therapy or metastatic, which is refractory, ineligible (in the opinion of the Investigator) or intolerant to standard therapy. Subjects with hepatocellular carcinoma must be diagnosed with dynamic CT or MRI if no tissue diagnosis is available.
* Subject must have performance status of 0, or 1 on the ECOG performance scale.
* Subject with adequate organ function.
* Life expectancy is longer than three months.
* Subject must be able to receive effective contraceptive measures.

Exclusion Criteria:

* Subject is allergic or intolerant to either anti-PD1 or interleukin-2 therapy.
* Subject has received prior immune-check point inhibitors and was discontinued due to greater than grade 3 toxicities.
* Subject is receiving other investigational agent or device.
* Subject has active infection, uncontrolled hypertension, unstable angina, uncontrolled diabetes mellitus, recent myocardial infarction, and congestive heart failure with ejection fraction less than 50%.
* Subject has prior allogeneic stem cell or bone marrow transplant or organ transplant.
* Subject has active central nervous system (CNS) metastases or carcinomatous meningitis.
* Subject with HIV whose viral load is \> 400 copies/mL or CD4+ T cell counts are \< 350 cells/µL.
* Subject has baseline corrected QT interval (QTc) longer than 480 ms by Fridericia formula.
* Subject is pregnant or breast-feeding.
* Subject has received live virus vaccine within 28 days prior to the first dose of study.
* Any other conditions that might compromise the safety of the subject or the integrity of the study.
Relation of Catechol-O-methyltransferase (COMT) Genotype and Response to Cognitive Remediation Schizophrenia

This project will explore the relationship between catechol-O-methyltransferase (COMT) Val158/108Met genotype and response to a 12-week computerized neurocognitive rehabilitation (CRT) given to chronic schizophrenic patients.

Cognitive deficits play a crucial role in both the pathogenesis and prognosis of schizophrenia. The COMT gene is functionally expressed in neural systems considered important in a range of healthy brain functions and brain disorders, including schizophrenia. The COMT Met allele has been shown to be associated with a lower activity form of COMT, and with better performance on neurocognitive tests, while the COMT Val allele is associated with poorer executive cognition. This study will investigate the relationship of COMT polymorphism in patients with chronic schizophrenia with the response to CRT targeting visuospatial processing, attention, and cognitive flexibility using MATRICS Consensus Cognitive Battery (MCCB) developed by the NIH-MATRICS initiative.

Eligibility Criteria:
Inclusion Criteria:

1. Participation in the active arm of the neurocognitive remediation program
2. Age 18 - 55
3. Inpatients
4. DSM-IV diagnosis of schizophrenia (all subtypes) with illness duration \>5 years
5. Auditory and visual acuity adequate to complete cognitive tests
6. Stable dose of oral atypical antipsychotic for at least 4 weeks
7. Total PANSS score \> 60
8. RBANS total score ≤ 80
9. MMSE score of greater than or equal to 24
10. Good physical health determined by physical examination, laboratory tests
11. Capacity and willingness to give written informed consent

Exclusion Criteria:

1. Inability to read or speak English
2. Documented disease of the central nervous system
3. History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)
4. Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions
5. HIV +
6. Patients diagnosed with substance dependence
7. Currently participating in another experimental study, except for the parent study.
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial

The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to ≤ 85 years
* Lp(a)≥ 200 nmol/L during screening
* History of ASCVD as evidenced by history of either:

  * Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or
  * Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor.

Exclusion Criteria:

* Severe renal dysfunction
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN), or total bilirubin (TBL) \> 2 x ULN during screening
* History of hemorrhagic stroke
* History of major bleeding disorder
* Planned cardiac surgery or arterial revascularization
* Severe heart failure
* Current, recent, or planned lipoprotein apheresis
* Previously received ribonucleic acid therapy specifically targeting Lp(a)
A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised

The purpose of this study is to evaluate the efficacy and safety of JNJ-268229 (Ultiva /Remifentanil Hydrochloride) in pediatric participants between 1 and 15 years of age during maintenance of general anesthesia.

This is multicenter, open-label (identity of assigned study drug will be known) one-arm study in pediatric participants receiving general anesthesia. The participants are children aged 1-15 years old, planned to undergo head and neck, thoracic (except heart), urological, orthopedic or plastic surgery. Approximately 80 participants will be enrolled in this study. These participants are divided into two groups by age (1-6 and 7-15 years old). Pharmacokinetic (what the body does to the drug,) blood samples will be collected from at least 3 participants between the ages of 1 and 6 years and at least 3 participants between the ages of 7 and 15 years from 15 minutes after the start of infusion to the end of infusion of the study drug . The study consists of 4 phases: screening phase, treatment phase, recovery phase and follow-up phase. Screening for eligible participants will be performed within 14 days before administration of the study drug. The safety and tolerability of study drug will be evaluated by physical examinations, electrocardiogram (ECG), clinical laboratory tests, vital signs, and adverse events (AEs) according to the Time and Events Schedule. Participants safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants scheduled to receive surgery under general anesthesia, necessitating airway securing with tracheal intubation and analgesia with opioid analgesics
* American Society of Anesthesiologists (ASA) Physical Status Classification is I or II at the time of operation planning
* Participants scheduled to receive operations estimated to take 30 minutes or more from skin incision i.e. Head and neck, thoracic (except heart), intraperitoneal, ophthalmological, otorhinolaryngological, urological, orthopedic or plastic surgery
* Girls having undergone menarche are eligible only if the urine pregnancy test at the time of screening is negative Exclusion Criteria:-
* Chronic use of opioid analgesics or their use within 12 hours before the planned start of general anesthesia - Hypersensitivity to opioid analgesics or local anesthetics
* History of jaundice or unexplained fever induced by halogenated anesthetics
* Unstable hemodynamics (eg. congenital heart disease, congenital diaphragmatic hernia) Ideal body weight is not within the 10th to 90th percentile received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the planned first dose of study drug or is currently enrolled in an investigational study
Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival

The leading risk factor for corneal transplant rejection is abnormal blood vessel growth of the host bed. Vascular endothelial growth factor (VEGF) is thought to be a mediator of this corneal neovascularization (NV), therefore we would like to test the safety and efficacy of local VEGF blockade in the promotion of graft survival in high risk corneal transplants.

The purpose of this study is to test the effectiveness of a drug, bevacizumab (Avastin), in preventing blood vessels that often occur after a corneal transplantation which are considered at "high-risk" for rejection. In many cases these blood vessels lead to the graft rejection and eventual failure of the corneal transplant. It is hoped that this treatment will increase the chances of corneal graft survival.

The medication used in this study is called bevacizumab or Avastin (Genentech, Inc). It works by inhibiting the action of a molecule called vascular endothelial growth factor (VEGF). VEGF is a substance molecule that binds to certain cells to stimulate new blood vessel formation. When VEGF is bound to the drug, it cannot stimulate the formation and growth of new blood vessels. Growth of blood vessels into the cornea is a complication which can worsen the prognosis of your corneal transplant and put the transplant at a higher risk for rejection.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patient or legally authorized representative willing and able to provide written informed consent
* Willing and able to comply with study assessments for the full duration of the study
* High-risk characteristics for penetrating keratoplasty: Either presence of 1.) Corneal NV in one or more quadrants (≥ 3 clock hours NV ≥ 2mm from the limbus) OR 2.) Extension of corneal NV to graft-host junction in a previous failed graft
* In generally good stable overall health

Exclusion Criteria:

* History of Stevens-Johnson syndrome or ocular pemphigoid
* Ocular or periocular malignancy
* Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively
* Uncontrolled glaucoma
* Currently on dialysis
* Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days of study entry
* Concurrent use of systemic anti-VEGF agents
* Change in topical corticosteroid regimen within 14 days of transplantation
* Use of systemic immunosuppressive for indication other than corneal graft rejection
* Pregnancy (positive pregnancy test) or lactating
* Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)
* Uncontrolled hypertension defined as systolic blood pressure (BP) ≥150 or diastolic BP ≥90 mmHg
* History of thromboembolic event within 12 months prior to study entry
* Participation in another simultaneous medical investigation or trial
PBBT and WBV Effect on Balance and Gait in Stroke

The goal of this clinical trial is to compare the effects of perturbation based balance exercises with whole body vibration training in sub-acute stroke patients and to evaluate their effects on balance, and gait. The main aim to :

* To evaluate their effects on balance, and gait.
* Comparison of these rehabilitation protocols and identify the more efficacious treatment.

Participants will perform perturbation based balance training and whole body vibration therapy to improve balance and gait.

If there is a comparison group: Researchers will compare both groups to see both interventions effects.

Stroke usually causes impairments in a variety of areas, such as cognition, emotion, mobility limitation, sensory loss, and there after results in imbalance and gait disability as well as impairment of the activities of daily living (ADLs). Poor balance control have a negative influence on the recovery of gait and motor function. Many therapeutic interventions, such as visual feedback training, robotic devices, mirror therapy, and motor imagery training have been performed to improve balance control.

Reactive balance training (RBT) has emerged as a potential strategy for improving balance and participants withstood greater-magnitude perturbations before requiring multiple steps, relative to those who completed weight-shifting/gait training in sub-acute and chronic stroke patients.

Whole-body vibration (WBV) therapy used in clinical practice for improving neuro-motor performance in various patient populations and this training reduce disability by improving balance, gait performance, and mobility in stroke patients.

According to previous literature there was a lack of comparison of these two studies. In previous literature, both of these therapeutic options i.e., Perturbation based balance training (PBBT) and whole body vibration (WBV) training were used separately to see the effects in stroke population but not in combination. In this study the comparison will be done between these two exercise protocols. Consequences will be manipulated for balance, and gait by using validated tools.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed patient of ischemic stroke (12 week to 20 weeks).
* Male and female, (40-60 year).
* Able to maintain standing posture, 4-5 score on level of independence scale.
* Patients able to perform 2-meter walk test.
* Score less than 20-24/56 on berg balance scale.

Exclusion Criteria:

* Patients with other neurological disorders (Alzheimer's, Parkinson's vestibular impairments etc.)
* Any significant balance impairment on Berg Balance Scale.
* Orthopaedic Problems.
* Patients who can't perform 30 sec sit to stand.
* Patients with any trauma, and blindness.
* Lower extremity weight bearing pain.