cyrilzakka/clinical-trials huggingface dataset:
Oculusgen (Ologen) Glaucoma MMC Control in Estonia

To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery.

The ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. The MMC application is as the standard.

Ologen collagen matrix is implanted on the top of sclera flap after the loose stich sclera flap is done for the filtering surgery. The concept of ologen collagen matrix is to creat the subconjunctiva bleb and modulate the wound healing for the surgery. By implanting ologen collagen matrix in the place, subconjuctival and trabdoor scars might be prevented. This is because the ologen collagen matrix is a 3-D scaffold porous structure that can guide fibroblast to grow randomly, instead of linear alignment. This can reduce the scar formation.

Doctors apply MMC for the glaucoma surgery is also trying to inhibite the scar formation. But MMC has been long time used and glaucoma specialists have not found anything to replace it.

Ologen collagen matrix concept is not INHIBITION, it is guiding and creating a physiological tissue. The successful of ologen collagen matrix may be on par with MMC but the safety and side effects will be much less.

Eligibility Criteria:
Inclusion Criteria:

* Max anti glaucoma medication failed,

Exclusion Criteria:

* Age less than 18, woman in pregnant, hemodialysis patient
Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies

This is an open-label, multicenter, extension study to evaluate the long-term safety and efficacy of BeiGene investigational drugs in participants with advanced malignancies who participated in a prior BeiGene-sponsored clinical study (parent study).

For the purposes of this study, "study treatment" will refer to all investigational agents. A parent study is defined as the original BeiGene-sponsored clinical trial in which the participant was initially enrolled and received BeiGene investigational drugs (with or without other treatments).

Eligibility Criteria:
Key Inclusion Criteria:

1. Currently participating in a BeiGene-sponsored eligible parent study
2. Fulfills treatment criteria specified in the parent study protocol
3. In the opinion of the investigator, the participant will continue to benefit from and tolerate any of the parent study treatments.
4. The first dose of study treatment in the LTE study will be received within the treatment interruption period allowed by the parent study:

   1. "Treatment interruption" (unplanned pause in study treatment) and "treatment break" (planned stop of study therapy) are not interchangeable. Restarting study treatment beyond the interruption period allowed by the parent study or after a treatment break will be determined by the investigator and the sponsor. Participants who have not restarted treatment within 1 year of starting a treatment break must discontinue treatment.

Specific Inclusion Criteria for Participants Who Continue Survival Follow-up Only in the Extension Study:

1. Currently participating in a BeiGene-sponsored eligible parent study in the survival follow-up portion
2. Parent study plans to have survival analysis

Key Exclusion Criteria:

1. Permanently discontinued from all investigational drugs in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent
2. Have uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy prior to the start of the extension study
3. Have a life-threatening illness, medical condition, or organ system dysfunction that in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of investigational drugs, or put the study outcomes at undue risk
4. Underwent treatment with any systemic anticancer treatment (other than treatment permitted in the parent study) during the time between the last treatment in the parent study and the first dose of study treatment in the LTE study
5. Pregnant or lactating women

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Effectiveness of Robot-assisted Upper-limb Exercise in Cervical SCI

The aim of the project is to test the effectiveness of robot-assisted upper-limb exercise in persons after cervical spinal cord injury. In a randomised controlled two-arm trial, the effect of adding two types of robot-assisted upper-limb exercise to standard occupational therapy will be tested. Three primary and two secondary outcomes will be assessed using well-established measures.

Unlike for persons after stroke, there is no high-quality evidence of the effectiveness of robot-assisted upper-limb exercise in persons after cervical spinal cord injury. For this reason, we are aiming to conduct a randomised trial. The trial will involve two groups of adult patients admitted to inpatient rehabilitation. One group will receive standard occupational therapy, tailored to the patient's needs and abilities, five times per week for 90 minutes. In addition to the standard occupational therapy, the other group will receive ten 30-minute session of robot-assisted exercise: five sessions of exercise for fingers and hand using a specialised device, and five sessions of gross-motor exercise using an exoskeleton. Three outcome measures will be used to comprehensively assess the patients at the beginning and at the end of the intervention, i.e., upon admission and discharge: the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP; general and Myelopathy version), the Spinal Cord Independence Measure (SCIM), and the Canadian Occupational Performance Measure (COPM). The progress in those measures will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* ability to move unloaded upper limbs
* at least 18 years of age
* ability to sit for one hour
* ability to understand the instructions for robot-assisted exercise

Exclusion Criteria:

* inability to sit for one hour
* presence of hospital-acquired infection that requires isolation
* bodily impairment other than spinal cord injury
* inability to understand the instructions for robot-assisted exercise
Neuromuscular Training vs Strength Training

Chronic ankle instability is a complex condition. Limited mobility, perceived instability, and recurrent ankle sprains are common characteristics that reduce the quality of life in subjects who suffer chronic ankle instability. Neuromuscular training and strength training has been recommended in chronic ankle instability management interventions. However, there are contradictory findings on results when comparing neuromuscular training, strength training, and control group.

Participants were randomly assigned to the neuromuscular training group, strength training group, and control group with no intervention if participants met the inclusion criteria.

Neuromuscular training group. It consisted of a multi-station training with 6 exercises, increasing the difficulty progressively as the participants controlled the execution. The exercises were all performed barefoot and with the injured foot. These were a combination of standing and jumping exercises involving the injured ankle.

A strength training group was performed with resistance bands. The band was fastened to the unaffected ankle, while the participant was told to perform front and back pulls, as well as adduction and abduction movements with the affected ankle. Participants were told to control the ankle movement and to make it slow.

Control group received no intervention.

Eligibility Criteria:
Inclusion criteria were consistent with recommendations made from International Ankle Consortium16 and were checked before the intervention:

* To have suffered the first sprain at least 6 months before the beginning of the study.
* Cumberland ankle instability score ≤24.
* To be physically active.

Exclusion criteria.

* Participants could not have suffered an acute sprain in the 6 previous weeks to the beginning of the study.
* History of recent ankle surgery.
* Epilepsy or previous seizures.
Iowa Produce Prescription Program

The goal of this study is to understand how a Produce Prescription Program paired with a behavioral nutrition intervention affect nutrition and overall health in low-income Iowans with type 2 diabetes or pre-diabetes. Research questions include:

1. What impact does a produce prescription program paired with a behavioral nutrition intervention on nutrition security compared to the behavioral nutrition intervention alone and usual care groups?
2. What impact does a produce prescription program paired with a behavioral nutrition intervention on hemoglobin A1c, fruit and vegetables intake, food security, and related behaviors compared to the behavioral nutrition intervention alone and usual care groups?

Participants of the behavioral nutrition intervention (Produce Your Path) alone will:

* Watch monthly nutrition education videos about topics like planning and budgeting for groceries, reading nutrition labels, eating more fruits and vegetables, and new recipes to try
* Complete a short quiz about their own goals and habits related to the topic
* (Optional): Join a Facebook group to communicate with other participants about their goals, share ideas and recipes, and ask questions

Participants of both the Produce Prescription and Produce Your Path Interventions will:

* Complete each monthly nutrition education module and monthly quiz
* (Optional): Join a Facebook group to communicate with other participants about their goals, share ideas and recipes, and ask questions
* Receive $30.00 per each person in their household monthly to buy fresh fruits and vegetables

Participants of the control group will:

* Follow their usual care for health conditions
* Complete the required data collection for the study


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Pre-diabetic or diabetic diagnosis by medical provider;
* Receiving medical assistance under a state plan (Medicaid) or eligible for Supplemental Nutrition Assistance Program (SNAP) benefits;
* Owns a smart phone;
* Able to read and understand English; speaks English;
* Patient at a partnering health care clinic;
* No one else in the household is enrolled in I-PPP

Exclusion Criteria:

* Under 18 years old;
* Not pre-diabetic or diabetic (as diagnosed by medical provider);
* Does not receive medical assistance under a state plan (Medicaid) or is not eligible for SNAP benefits;
* Does not own a smart phone;
* Cannot read or understand English;
* Does not speak English;
* Is not a patient at a partnering health care clinic;
* Others in household participating in I-PPP
Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada (EMMA Can)

EMMA-Can is a prospective cohort study to assess the safety and effectiveness of MMA-embolization for the treatment of CSDH.

Hypothesis- EMMA reduces the recurrence rate of SDH with or without concomitant surgical evacuation.

The purpose of our study is to conduct a prospective cohort study to assess the safety and effectiveness of MMA embolization for the treatment of CSDH. All patients with CSDH presenting to the emergency room or to neurosurgical outpatient clinic will be screened for potential enrollment. If the subject is willing to participate an informed consent will be obtained.

All patients presenting to the emergency room or in neurosurgery clinic with CSDH diagnosed on CT scan will be considered for the study. If the patient needs emergent evacuation for clinical reasons, patient will be taken for surgical evacuation before consideration of EMMA. Patients that are more likely to have recurrence after surgical evacuation are those with recurrent CSDH, on antiplatelet or antithrombotic treatment. The EMMA could be used as primary treatment or in conjunction with surgery in these patients or in patients who may not be good surgical candidate.

Follow up - All patients will be followed after discharge from the hospital at 1, 3 and 6 months interval. The follow up at 1 and 3 months will include plain CT head of the patient, which is standard of care for most patients. The follow up at 6 months will be only clinical follow up.

Patients will be assessed for recurrence of CSDH on CT scan of head. The size of the CSDH will be measured and compared to previous scans and peri-procedural morbidity and mortality related to EMMA will be sought. This will be done at 1 and 3 months post EMMA.

Eligibility Criteria:
Inclusion Criteria:

* All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic

Exclusion Criteria:

* When informed consent is not possible
* Known allergy to liquid embolic agent
Inspiratory Flow Parameters and Handling of Easyhaler and Turbuhaler Inhalers

The aim of the study is to measure the inspiratory flow that the different patient groups (asthmatic children, adults and elderly, as well as chronic obstructive pulmonary disease (COPD) patients) generate through empty Easyhaler (two versions) and Turbuhaler inhalers. In addition, the handling and acceptability of the inhalers will be compared in asthmatic children.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained.
* Documented diagnosis of asthma and/or COPD (a range of different severities for both diseases).
* Age: 6 years or above.

Exclusion Criteria:

* Any severe chronic respiratory disease other than asthma or COPD.
* Acute respiratory infection.
* Concurrent participation in a clinical drug study.
* Inability to perform repeatable spirometric measurements.
* Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study (such as contraindications to spirometry).
Impact of Temporomandibular Joint Dysfunction on Objective and Subjective Vocal Measures

The present study aims to investigate the impact of temporomandibular joint dysfunction (TMD) on objective and subjective vocal parameters and the quality of life in affected patients. TMD is a pervasive public health issue that impacts approximately 25% of the general population and is notably more prevalent among women. The etiology of TMD is multi-factorial, with known risk factors such as parafunctional habits, emotional stress, occlusion issues, and orthodontic treatments. Internal derangements of the temporomandibular joint are the most common subtype of TMD, characterized by symptoms such as pain, joint noises, restricted mouth opening, and masticatory dysfunction.

This study particularly focuses on the limitations in mouth opening due to TMD and its effects on vocal characteristics and quality of life. Conservative treatment methods, such as non-steroidal anti-inflammatory drugs (NSAIDs) and occlusal splints, have been effective in symptom management unless there is clear evidence of joint collapse or ankylosis. The null hypothesis (H0) posits that the restriction in mouth opening has no impact on vocal parameters or quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18 and 65 years.
* Capable of giving informed consent.
* Fluent in the local language for effective communication.
* No history of hearing impairment or high communicative demands in their profession.
* Absence of a history of vocal disorders or conditions affecting voice quality.

Exclusion Criteria:

* Individuals with a vocal disorder.
* Unable to provide informed consent or meet study requirements.
* Pregnant or lactating women.
* Presence of any medical condition that could potentially affect voice quality.
Phase 2 Study to Examine Grape Seed Extract as an Anti-Oligomerization Agent in Alzheimer's Disease (AD)

Alzheimer Disease (AD) is a progressive brain disease generally known as senile dementia. Our proposed study will establish safety and pharmacokinetics of Meganatural-AZ GSPE in AD subjects. As secondary measures, we will also provide the essential human data to guide the design of future studies to test the efficacy of GSPE in mitigating cognitive deterioration in AD patients.

This study aims to establish the safety and pharmacokinetics of Meganatural-Az® GSPE in subjects with Alzheimer's disease. As a secondary goal, clinical and biomarker indices of therapeutic efficacy will also be evaluated. The proposed study will provide the essential human data necessary to guide the design of future studies testing the efficacy of GSPE in mitigating cognitive deterioration in AD patients.

Eligibility Criteria:
Inclusion Criteria:

* NINCDS/ADRDA criteria for probable AD
* MMSE between 12-26
* Treatment with a cholinesterase inhibitor or an NMDA (N-methyl-D-asparate) antagonist with stable dose for at least 12 weeks
* Home monitoring available for supervision of medications
* Caregiver available to accompany patient to all visits and willing to participate in study as informant
* Fluent in English or Spanish
* Medical stability for this study as confirmed by review of records, internist's physical exam, neurological exam, and laboratory tests
* Stable doses of non-excluded medication
* No evidence of hepatic insufficiency
* Able to swallow oral medications
* Ability to participate in the informed consent process

Exclusion Criteria:

* History of hypotension or unstable hypertension
* Active hepatic or renal disease
* Use of another investigational drug within the past two months
* History of clinically significant stroke
* History of seizure or head trauma with disturbance of consciousness within the past two years
* Major mental illness including psychotic disorders, bipolar disorder, or major depressive episode that is not in remission for less than 12 months
* Women of child-bearing age unless using effective birth control or at least one year post-menopausal or surgically menopausal
* Any ferrous or metallic materials which are contraindicated for MRI

Medication Exclusions

* Current use of drugs with significant anticholinergic or antihistaminic properties
Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy

Open prospective clinical trial to develop the computer software (Intelligent prognostic system) for predicting the efficacy of anti-PD-1 immunotherapy of melanoma patients in routine practice


Eligibility Criteria:
Inclusion Criteria:

1. Morphological verification of cutaneous melanoma. Verification of metastases is not necessary
2. ECOG 0-1
3. Age of patients - 18 years and older
4. No prior chemotherapy, immunotherapy, radiation or hormonal therapy
5. Adequate contraception for women of childbearing age
6. Written consent of the patient to participate in the study

Exclusion Criteria:

1. Non-compliance with the previously listed criteria
2. Pregnancy and breastfeeding
3. Therapy with systemic corticosteroids and/or other immunosuppressants within 4 weeks before the screening or a high probability of the need for their use during the study for the treatment of intercurrent pathology
4. History of another malignancy other than the study indication under this trial within 5 years of study enrollment. Does not apply to subjects who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, in situ cervical cancer, in situ breast cancer, or other in situ cancers.
Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers

Human papilloma virus-related gynecologic malignancies affect over 20,000 women in the United States, and over half a million women globally each year. In addition, approximately 200,000 women are diagnosed with high-grade cervical dysplasia, a pre-cancerous tumor. There is no currently available serum biomarker for these tumors, and surveillance and diagnosis in these patients often requires invasive testing and procedures. The ability to diagnose and monitor for these cancers with a simple blood draw would have a significant impact both here in the US and abroad.

In order to detect circulating tumor-specific HPV DNA, the investigators will collaborate with the molecular diagnostics company, Naveris. Naveris has designed a blood test that utilizes digital droplet polymerase chain reactions (PCR) in order to quantify fragments of tumor-specific DNA that the investigators believe is shed by HPV-associated cancer cells in the blood.

In this pilot study, the investigators will first test whether the quantification of plasma cell-free HPV DNA can distinguish pre-invasive from invasive cervical cancers.


Eligibility Criteria:
Inclusion Criteria:

All patients above age 18, with biopsy proven HPV-related high-grade cervical dysplasia or invasive cervical cancer will be included.

Exclusion Criteria:

Persons who do not meet the above inclusion criteria.
Empower@Home:Connected - Feasibility and Preliminary Effect Study

This single-group trial will evaluate the feasibility and preliminary effect of a novel group-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. Participants will complete the program remotely in small groups.

Depression affects up to 40% of homebound seniors, but most do not receive psychotherapy due to various access barriers. This study focuses on developing community-based solutions to reduce access barriers. In a previously approved project HUM00207612, the investigators tested the feasibility of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. This study will test an adapted version of Empower@Home called Empower@Home: Connected that is delivered in a group format and also addresses social isolation and loneliness. Recruitment methods include 1) referrals from social service agencies, 2) advertisements on social media, local news outlets, and the program website, and 3) research participant registries.

The intervention involves attending 9 group sessions. The sessions are facilitated by a mental health professional and involve psychoeducational material, cognitive-behavioral therapy exercises, and socialization. Sessions will occur on 9 consecutive weeks and will last approximately 90 minutes. Participants will complete a comprehensive baseline assessment and post-test. Each assessment will take between 40-60 minutes to complete over the phone. Recruitment will occur between January and April 2023, 20-25 participants will be recruited. All participants will receive the intervention.

Eligibility Criteria:
Inclusion Criteria:

* \>=60 years
* have at least mild depressive symptoms, based on PHQ-9 \>=8
* are willing to participate

Exclusion Criteria:

* Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score \>9).
* They do not speak English
* have active suicidal ideation, defined as moderate to high risk based on the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS)
* Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months
* Have severe vision impairment that can not be corrected
* Have probable substance use disorders as assessed by the 4-item CAGE screener (\>=2 on the CAGE AND have not been sober for at least one year)
* Have a self-reported psychotic disorder or bipolar disorder