cyrilzakka/clinical-trials huggingface dataset:
An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber

An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry Eye Disease in a Dry Eye Chamber


Eligibility Criteria:
Inclusion Criteria:

1. Eighteen (18) to70 years of age at the time of screening (either gender and any race).
2. Ability to provide written informed consent.
3. Reported history of dry eye for at least 6 months prior to Visit 1.

Exclusion Criteria:

1. Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1.
2. Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial.
3. A condition that the investigator feels may put the subject at significant risk may confound the study results or may interfere significantly with the subject's participation in the trial.
4. Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits.
Innovations to Prevent Relapse Among Low-income African American Smokers

The purpose of this research is to study a relapse prevention program for adult former smokers in Northeast Ohio. The study will also look at how different people respond to the program. Participants asked to take part in this study because they contacted the team for help remaining tobacco-free or otherwise expressed interest in the program. The study includes completing surveys and receiving text messages to help stay tobacco free.

The main objective of this study is to conduct a pilot study to assess the feasibility, acceptability, and initial efficacy/clinical significance of a tobacco relapse prevention intervention designed for low-income African Americans.

In this study, the team will estimate effect sizes for a culturally specific (CS) relapse prevention intervention compared to standard relapse prevention in a sample of low-income African American smokers and examine predictors of time to smoking relapse.

In a community-based clinical trial, adults who recently quit smoking (N=100) will be randomly assigned to one of two experimental conditions: (1) CS Relapse Prevention or (2) Standard Relapse Prevention. The primary outcome variables collected will include biochemically verified point prevalence abstinence (ppa) at 6-weeks and time to smoking relapse (TTR) over 3-months. This study will test daily hassles, cessation self-efficacy, coping strategies, and adherence to NRT as individual difference factors that may affect response to CS relapse prevention.

Eligibility Criteria:
Inclusion Criteria:

* Adult smokers recruited from the community by study community navigator and flyers
* Self-identify as African American
* Report no tobacco smoking within the past 3-90 days and have a carbon monoxide (CO) reading of ≤ 3 ppm
* Have access to SMS texting
* Meet federal definitions of low-income

Exclusion Criteria:

- Study team will offer to enroll ineligible smokers in the publicly available smokefreeTXT (if applicable) or refer them to the Ohio state quitline
Personalized Antisense Oligonucleotide Therapy for a Single Participant with LMNB1 Mutation Associated Autosomal Dominant Leukodystrophy (ADLD)

This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single participant with Autosomal Dominant Leukodystrophy (ADLD) due to LMNB1 mutation

This is an interventional study to evaluate the safety and efficacy of treatment with an individualized antisense oligonucleotide (ASO) treatment in a single participant with Autosomal Dominant Leukodystrophy (ADLD) due to LMNB1 mutation

Eligibility Criteria:
Inclusion Criteria:

* Informed consent provided by the participant (when appropriate), and/or participant's parent(s) or legally authorized representative(s).
* Autosomal dominant adult-onset leukodystrophy (ADLD) caused by an LMNB1 duplication mutation
* Ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records.
* Willingness to follow contraceptive guidance during the intervention period and for at least 40 weeks after the last dose of study intervention

Exclusion Criteria:

* Participant has any condition that in the opinion of the Site Investigator, would ultimately prevent the completion of study procedures
Atlantis Symbicort

The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma
* Baseline lung function tests as determined by protocol
* Required and received treatment with inhaled corticosteroids within timeframe and doses specified in protocol

Exclusion Criteria:

* Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a beta-blockers
* Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator
Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis

Endometriosis (including adenomyosis) is one of the most common gynecological diseases among women of childbearing age. Common symptoms such as menstrual pain, excessive menstrual flow, infertility, chronic lower abdominal pain, and painful intercourse. According to the literature statistics, the prevalence of endometriosis in women of childbearing age is about 10-20%, while the prevalence of adenomyosis is about 5%. Traditional medical treatments include hormones (danazol, gestrinone, oral lutein). Oral contraceptive, there is a Gonadotropin-releasing hormone agonist in the injection form, and a levonorgestrel-releasing intrauterine system in the intrauterine administration system. The choice of drugs has many influencing factors, such as the severity of endometriosis in patients (according to the classification of the American Society for Reproductive Medicine), the need for fertility, the convenience of drug use, and the patient's tolerance to drug side effects. Surgery is also one of the treatment options for endometriosis and adenomyosis, including traditional open or minimally invasive endoscopic ovarian cyst resection, oophorectomy, and lesion resection; adenomyosis surgery includes traditional methods Open abdominal, transvaginal or minimally invasive endoscopic hysterectomy, conservative uterine sparing adenomyomectomy and cytoreduction surgery (partial adenomyomectomy). For endometriosis, the common treatment consensus of obstetricians and gynecologists is to follow the surgical treatment of the lesions and then follow-up medication. For women with adenomyosis, if they have completed the birth, it is recommended to have a total hysterectomy, so that there is no recurrence. The possibility. However, for women who have not completed birth, conservative uterine preservation surgery is performed. According to research statistics, endometriosis or adenomyosis does not receive follow-up medical treatment after completion of surgical treatment, there is a high probability of recurrence, but the side effects caused by drugs will also affect the patient's compliance with medication.The Department of Women's Medicine of the hospital has a wealth of experience in the treatment of endometriosis and adenomyosis. Each year, about 500 cases of endometriosis (including adenomyosis) are performed. This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments.

The main purpose: to analyze the prognosis and treatment effect of endometriosis and adenomyosis after surgery and drug treatment.

Secondary objective: Analysis of endometriosis and adenomyosis after surgery and medication, the patient's assessment of drug side effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent endometriosis or adenomyosis-related surgery in the investigator's hospital from 2005/01/01 to 2018/12/31, and received follow-up medication.

Exclusion Criteria:

* None
Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

The purpose of this study is to evaluate the effect of pulse widths \<500 μsec and \>1000 μsec on clinical outcomes during a temporary SCS trial.

The proposed study is a prospective, multi-center, two-arm, randomized, crossover design to be conducted at up to 10 sites. The study will enroll up to 100 subjects in order to include up to 10 subjects in the study per site. Subjects selected to participate in the trial have back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a temporary SCS trial using the Algovita® system with percutaneous leads. Each subject will be followed during the trial period of approximately 7+/-2 days. The study will end when the last subject has completed the trial period and exited. The expected enrollment period for this study is approximately six months. After exit from the clinical study, subjects will continue to be followed by their physician per usual care. All device and procedure-related AEs will be collected and reported per the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* be eligible for SCS therapy according to the Algovita® SCS system Indications for Use statement
* be undergoing a SCS trial using Algovita® SCS system
* sign a valid, Institutional Review Board (IRB)-approved informed consent form.
* be 18 years of age or older when written informed consent is obtained

Exclusion Criteria:

* be contraindicated for an Algovita® SCS system
* have a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments
* have a life expectancy of less than 2 years
* be participating in another clinical study that would confound data analysis
* have a coexisting pain condition that might confound pain ratings
* have a significant psychiatric disorder
Prospective Population Study on Candidemia in Spain

The aim of this study is to describe the epidemiology of fungal blood infections in Spain (with emphasis on the incidence, fungal species distribution and antifungal susceptibility). The study is to be performed in five big cities which represent different geographic areas: Barcelona, Bilbao, Madrid, Sevilla and Valencia.


Eligibility Criteria:
Inclusion Criteria:

* Fungal isolate obtained from blood sample

Exclusion Criteria:

* None
Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies

The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.

The focus in this trial is on the occurrence of any late adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI), i.e. relapse or progression of the underlying disease, life-threatening infections, death due to any case, new and secondary malignancies, lymphocyte counts, detection of the transgene of the CAR T cells, detection of replication-competent lentivirus (RCL), developmental tracking in pediatric patients and furthermore, assessment of the primary status of disease progression and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Patient underwent treatment with a Miltenyi CAR T cell therapy in one of the parent trials at least 12 months prior to enrollment in long-term follow-up.
* Patient has provided informed consent prior to enrollment.

Exclusion Criteria:

* No exclusion criteria
Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)

Therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a significant number of them either in a context of recovery or in prolonged remission close to a chronic disease. Thus, the reconquest of a life after cancer becomes possible but raises many challenges for the patient, his entourage, the medical profession and our society. One of the major challenges is the detection and management of treatment side effects for all patients. In addition to the standard organic assessment (glycaemia, creatinine, liver test, blood count), we are mainly interested in muscle deconditioning and cognitive impairment, which are particularly disturbed in these populations. After the evaluation day, patients are referred to the most appropriate structures (Adapted physical activity, sports for health, and rehabilitation at Henry Gabriel Hospital).

JUMP research is part of axis 2 of the 2021-2030 cancer plan: "Limiting sequelae and improving quality of life", through sheets 1 (research) / 6 (access and quality) / 7 (prevention). This leads to the concrete implementation on the territory of adapted care channels in the city: medical structure, physiotherapy, Adapted Physical Activity (APA) structures, associative structures; which makes it possible to develop and strengthen the city-hospital link. Finally, it allows the patient to take ownership and get involved in the project, allowing in the future to make them truly active in they care and to advise and motivate their peers.

This non-interventional research is classified as "research involving human subjects", class 3 .

The objective of this research is to evaluate the impact of cancer on the musculoskeletal system and to test ultrasound as a clinical examination for the detection of sarcopenia in this population.


Eligibility Criteria:
Inclusion Criteria:

* Age : 18 to 74 years
* localization of the primitive: breast, lung, melanoma, testicle, bladder, kidney, ovary, colon and pancreas, hemopathy
* patient who benefited from the post-cancer assessment day

Exclusion Criteria:

* Active cancer (relapse or new cancer)
* Pregnant or breastfeeding women
* Major cognitive impairment making comprehension and exercise difficult
* Amputation of both lower limbs (for ultrasound)
* Difficulty understanding oral and written French
* Adults under legal protection (guardianship, curatorship or safeguard of justice)
Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus

This study is designed to evaluate maternal virological and immunological parameters to determine their ability to predict congenital cytomegalovirus (CMV) infection. When a pregnant woman is infected with CMV, her immune system (which protects her from infection) is activated and the virus can be found in the woman's bodily fluids (blood, saliva, urine, vaginal secretions). The aim of this study is to find out if there is a link between either the pregnant woman's immune response or the presence of the virus in these bodily fluids and the child/foetus being infected with the virus.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol .
* A pregnant female, 18 years of age or older at the time of study enrolment.
* Women with confirmed primary CMV infection.
* Written informed consent obtained from the subject.

Exclusion Criteria:

* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational pharmaceutical product.
* Previous vaccination against CMV infection.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history or physical examination
* Major congenital defects, serious chronic illness or organ transplantation.
* Administration of immunoglobulins and/or any blood products within the three months preceding study enrolment or during the pregnancy.
* Documented Human immunodeficiency virus (HIV)-positive subject.
* Gestational age of more than 34 weeks, as determined by foetal ultrasound.
Home Exercise With Wearable Sensors

Repetitious motor therapy has been shown to yield the greatest improvement in motor function in those who suffer hemiplegia because of a neurological impairment. However, motor therapy remains largely clinically based due to the absence of quantitative home-based therapy technology or equipment. With the current lack of accountability, patient adherence to home exercise physical therapy programs is estimated to be as low as 35%. In response, some companies have extended the applications of their motion capture devices to be used for home-based physical therapy. However, the technologies often have not passed their initial stages of development. In contrast, a company named 4D Motion is actively working alongside the Restorative Neurology Clinic at Burke Medical Research Institute to develop a motion capture system tailored to the motor rehabilitation of hemiplegic stroke patients. This device is driven by a user's active range of motion and does not impart electrical or mechanical stimulation to the user. The device does not force the user beyond their active range of motion and does not apply resistance to motion that limits the user's capability. The 4D Motion capture system is only used to record what the patient is doing and to promote adherence to their prescribed physical therapy plan.


Eligibility Criteria:
Inclusion Criteria:

* Able to follow 1-2 step commands
* Neurological deficit leading to hemiparesis or hemiplegia with a sensorimotor deficit
* Fugl Meyer Upper Extremity Score of at least 20/66

Exclusion Criteria:

* Has a metal implant anywhere on or inside the body
* Fixed contracture or deformity of affected upper extremity
* Individuals with bilateral stroke (i.e. if both arms are affected)
* Unable to tolerate repetitious movement as determined by Likert Scale Rating greater than 5 out of 10
WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy

This is a randomized control trial testing the effect of walnut supplementation on prostate cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo RP. Patients consented to the study will be randomly assigned to either continue their usual diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their consent date and the date for RP.

The overall objective of this study is to test the effect of walnuts added to a usual diet on prostate cancer progression as measured by Ki67 expression in the prostate tissues. Subjects will be randomized 1:1 to usual diet or usual diet with the addition of 2 ounces of walnuts daily. The baseline visit will occur in conjunction with a standard of care visit post-biopsy, the intervention period will range from 4-10 weeks dependent upon the scheduled date of the standard of care radical prostatectomy (RP), and the final visit will occur in conjunction with a standard of care visit prior to RP.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed prostate adenocarcinoma.
* Diagnostic biopsy cores with ≥10 cores with each core examined separately to determine exact tumor location.
* Biopsy grade group 2 or higher (Gleason ≥7).
* Planning to undergo RP.
* Willing to adhere to a usual diet with the possible addition of 2 oz of walnuts per day.
* Reads, writes, and understands English.
* Age 18 or older

Exclusion Criteria:

* Allergy to nuts.
* History of receiving hormone therapy or antiandrogen therapy.
* Use of 5-alpha reductase inhibitors in the past 6 months.
* Prior prostate radiotherapy (external beam or brachytherapy) or prior prostate cryotherapy.
* Currently enrolled in a modified diet/weight loss program and/or taking dietary supplements that contain omega-3s (e.g., fish oil).
* Other active malignancy, excluding basal cell carcinoma or squamous cell carcinoma
* Significant co-morbidities (e.g., cardiac, pulmonary, liver disease, alcohol/drug addiction, malabsorption syndromes), that in the opinion of the study physician make the patient ineligible.
* Individuals with psychological/mental conditions which can affect the consent process and/or their adherence to the protocol.
Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years and able to give informed consent
2. written informed consent to participate in the clinical trial
3. typical angina pectoris or non-invasive evidence of relevant ischemia under optimal drug therapy
4. angiographic evidence of coronary artery disease
5. de novo lesion in a native coronary artery
6. target vessel diameter 2.5-4 mm
7. severe calcification of the target lesion (angiographic grade 3)

Exclusion Criteria:

1. myocardial infarction \<1 week
2. thrombus in the target vessel
3. life expectancy due to other disease \<1 year
4. simultaneous participation in a clinical trial with medical devices or medicinal products that has not yet been completed
5. pregnancy (current, suspected, planned) or positive pregnancy test
Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines

This study to assess aesthetic improvement following treatment with QM1114-DP.

This is an open-label, single-center multi-center study to assess aesthetic improvement in the Glabellar and Lateral Canthal regions following treatment with QM1114-DP.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female 18 years or older
* Moderate to severe bilaterally symmetrical LCL as assessed by the investigator
* Moderate to severe GL at maximum frown as assessed by the Investigator

Exclusion Criteria:

* Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
* Female who is pregnant, breast feeding or intends to conceive a child during the study.
* Known allergy to hypersensitivity or any component of the Investigational product
To Evaluate The Effects Of SB-649868 (10, 30 Mg And 60 Mg) On Subjects With Primary Insomnia

This study to evaluate the effects of SB-649868 (10, 30 mg and 60 mg) on sleep continuity, PSG sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects with primary insomnia


Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-64 years of age (inclusive),
* Diagnosis of primary insomnia who have had symptoms for at least three months.

Exclusion Criteria:

* Any clinically significant unstable medical or surgical condition (treated or untreated).
* Any history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (including febrile seizure).