cyrilzakka/clinical-trials huggingface dataset:
A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the AZD0486 plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.

The study consists of 2 sequential parts.

1. Safety Run-in - this part will compare dose levels of AZD0486 in combination with rituximab in order to establish the RP3D.
2. Phase III - The Phase III part will assess the superiority of AZD0486 at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms

   1. Arm A: treatment with AZD0486 plus rituximab Schedule A
   2. Arm B: treatment with AZD0486 plus rituximab Schedule B
   3. Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance and B-R

Eligibility Criteria:
Inclusion Criteria:

1. Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
2. Histologically confirmed diagnosis of FL Grades 1-3A per WHO 2016 classification
3. ECOG performance status of 0 to 2
4. No prior systemic lymphoma-directed therapy
5. Need for systemic treatment meeting at least 1 GELF criteria
6. FDG-avid and measurable disease
7. Adequate liver, hematological, renal and cardiac function.

The above is a summary, other inclusion criteria details may apply

Exclusion Criteria:

1. Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
2. Contra-indication to BR, RCVP, and R-CHOP
3. Participants with or history of CNS lymphoma
4. Presence of \>5000 circulating lymphoma cells
5. Active or uncontrolled infection requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study

The above is a summary, other exclusion criteria details may apply
ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama

It is unclear whether peer coaching is effective in minority populations living with diabetes in hard-to-reach, under resourced areas such as the rural South. We examined the effect of an innovative peer coaching intervention plus brief education vs. brief education alone on diabetes outcomes.

The purpose of this project was to provide robust evidence on the effectiveness of a peer support intervention in improving diabetes outcomes by conducting a group-randomized, controlled implementation trial of a volunteer peer support intervention.

The study had three specific aims:

Aim 1. In Phase I (months 0-8), to perform a qualitative needs assessment with peer advisors and health care providers to inform peer advisor roles and responsibilities (i.e., the intervention) and peer advisor recruitment strategies, curriculum and training; and patient recruitment plans.

Aim 2. Also in Phase I, to pilot our collaboratively developed intervention and, based on pilot test results, to recruit and train peer advisors for the intervention, and begin patient recruitment.

Aim 3. In Phase II (months 9-32), conduct the group randomized implementation trial and evaluate it using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.

Eligibility Criteria:
Inclusion Criteria:

* 19 or older in age, diagnosed with diabetes, under the care of a doctor

Exclusion Criteria:

* not community dwelling, less than 19 years old, pregnant, end-stage medical conditions with limited life expectancy, no access to telephone, does not speak english
Profiles of Expression in HPV+ Versus HPV Head and Neck Cancers

Squamous cell cancers of the head and neck are classically correlated to excessive consumption of alcohol and tobacco and have a rather poor prognosis. However, the incidence of Head and Neck cancers in patients without alcohol-smoking risk factor has continued to increase in recent years, in relation to more and more frequent HPV contamination.

Some studies show a difference in the expression of certain genes within the two groups of tumors (HPV+ and HPV-) including some that confer sensitivity to certain chemotherapies and others to radiotherapy. However, patients with HPV+ Head and Neck cancers are treated according to the same referential as HPV- Head and Neck cancers. There is therefore a real need for studies identifying predictive markers in order to be able to offer patients a more effective suitable and less invasive treatment.

Head and neck cancers are the sixth most common cancer common worldwide causing more than 380,000 deaths each year. More than 90% of these cancers are carcinomas epidermoids arising from the mucosal surfaces of the cavity oral cavity, oropharynx and larynx.

Squamous cell cancers of the head and neck are classically correlated with risk factors linked to excessive consumption of alcohol and tobacco and have a rather poor prognosis (mainly HPV (Human Papilloma Virus) negative patients).

However, the incidence of Head and Neck cancers in patients without alcohol-smoking risk factor has continued to increase in recent years, in relation to more and more frequent HPV contamination. Evolution of oral sexual practices seems to be one of the explanations for the progression of these cases of oropharyngeal squamous cell carcinoma and oral cavity HPV positive.

Some studies show a difference in the expression of certain genes within the two groups of tumors (HPV+ and HPV-) including some that confer sensitivity to certain chemotherapies (CCND1, TYMS) and others to radiotherapy (RBBP4). However, patients with HPV+ Head and Neck cancers are treated according to the same referential as HPV- Head and Neck cancers. There is therefore a real need for studies identifying predictive markers in order to be able to offer patients a more effective suitable and less invasive treatment. This is the context of this research project.

Eligibility Criteria:
Inclusion Criteria:

* Patient with oropharyngeal squamous cell carcinoma or the oral cavity histologically proven.
* Primary tumor for which a biopsy or excision is required available and sufficient to carry out molecular analysis

Exclusion Criteria:

- Patient with Head and Neck cancer other than oropharyngeal or oral cavity squamous cells carcinomas
Characteristics of Nondystrophic Myotonias

Nondystrophic myotonias (NDM) are muscle disorders caused by genetic abnormalities in certain muscle cell membrane proteins. Individuals with NDM experience limited muscle relaxation, which causes pain, weakness, and impaired physical activity. The purpose of this study is to better characterize the clinical features and symptoms of NDM.

Nondystrophic myotonias are muscle disorders caused by abnormal muscle cell membrane proteins that affect the control of muscle fiber contraction. These disorders are extremely rare, and little is known about how to best treat the various subtypes of NDM. The purpose of this study is to characterize the clinical features and symptoms of NDM as well as to pair this data with specific NDM subtypes. In turn, this may lead to the development of improved treatments. The study will also establish clinical endpoints for use in future studies.

This multi-center observational study will involve both a cross-sectional data analysis and a prospective longitudinal analysis. Participants will initially attend a one-day outpatient study visit. Various baseline measurements will be collected, including demographics, medical history, and quality of life measures. Blood samples will be taken to evaluate laboratory values and genetic factors. Participants will undergo manual muscle testing (MMT), clinical myotonia assessments, and functional movement assessments. Routine nerve conduction studies and electromyography (EMG) will also be performed in order to test for the presence of myotonia in specific muscles. Annual follow-up evaluations will occur 1 and 2 years following the first study visit.

Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms or signs suggestive of myotonia
* Presence of myotonic potentials on electromyography (EMG)
* Persistence of symptoms and signs after discontinuation of medications that produce myotonia; such medications include fibric acid derivatives, hydroxymethylglutaryl CoA reductase inhibitors, chloroquine, and colchicine
* Absence of features suggestive of myotonic dystrophy, including ptosis, temporal wasting, mandibular weakness, cataracts occurring before age 50, and evidence of multisystem defects (cardiac conduction defects, hypogonadism)

Exclusion Criteria:

* Any other neurologic condition that might affect the assessment of the study measurements
A Comparative Study of Sibling Oocytes: ICSI vs. the PICSI Sperm Selection Method

The aim of this research is to compare sibling oocytes using two sperm selection methods for choosing the best quality spermatozoa before they are injected into oocytes and the influence of each of these methods on embryo quality and IVF outcome.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 18-60
* Females aged 18-35
* Males with mild OTA (oligo terato astheno zoospermia) and at least one failed IVF cycle
* Males with normozoospermia with at least 2 unexplained failed IVF cycles
* Females with normal FSH and normal AMH values
* Females who have retrieved in previous cycles at least 6 oocytes

Exclusion Criteria:

* Couples who have been exposed to heavy smoking, drugs and chronic diseases
* Males who have undergone testicular surgery (TESE) or defined as severe OTA
* Females with egg factor infertility
Understanding Chronic Lymphocytic Leukemia

The purpose of this study is to collect human Chronic Lymphocytic Leukemia tissue samples and medical information, in order to find out more about the causes and biology of chronic lymphocytic leukemia.

The purpose of this study is to collect human Chronic Lymphocytic Leukemia tissue samples and medical information, in order to find out more about the causes and biology of chronic lymphocytic leukemia, for the potential development of more effective therapies for this disease.

Eligibility Criteria:
Inclusion Criteria:

* New and existing patients seen for treatment of monoclonal B-cell lymphocytosis
* Any low grade lymphoproliferative disorder
* Chronic Lymphocytic Leukemia in the Dana Farber Cancer Institute Hematologic Oncology Clinic or elsewhere

Exclusion Criteria:

-
A Clinical Assessment Study of Subjects With Mucopolysaccharidosis IVA (Morquio Syndrome)

This multicenter, multinational, longitudinal study will quantify endurance and respiratory function in subjects diagnosed with MPS IVA and will better characterize the spectrum of symptoms and biochemical abnormalities in MPS IVA disease over time.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written, signed informed consent, or in the case of subjects age \< 18 years, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
* Documented history of reduced GALNS activity relative to the normal range of the laboratory performing the assay, or documented result of molecular genetic testing confirming diagnosis of MPS IVA.
* Willing and able to comply with all study procedures.

Exclusion Criteria:

* Use of any investigational product or investigational medical device within 30 days prior to screening.
* Previous hematopoietic stem cell transplant (HSCT).
* Concurrent disease or condition that would interfere with study participation or pose a safety concern.
Psychophysiologic Predictors of Post-deployment Mental Health Outcomes

The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions.

The primary objectives of this proposal are to develop objective pre-deployment predictors of PTSD and test two pre-deployment resiliency interventions. The objective predictors will be based on: 1) physiologic reactivity (heart rate, heart rate variability, eye blink startle, skin conductance) to virtual reality (VR) environments depicting common Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF) combat scenarios and 2) cognitive bias assessment using a recognition memory paradigm. We hypothesize that a model combining physiologic reactivity and cognitive bias predictors will be superior to either the physiologic reactivity or cognitive bias model alone for predicting post-deployment PTSD. We also will test two pre-deployment resiliency interventions: heart rate variability biofeedback and cognitive bias modification training that we have designed to target physiologic and cognitive responses to stress, respectively. We will compare the prevention interventions to a no intervention control group. We hypothesize that the prevalence of post-deployment PTSD will be lower in the intervention groups compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Army National Guard members who are scheduled to deploy for OIF/OEF operations within the next 12 months, age 18 to 60, and willing to provide the name and phone number of at least one person to help locate the member for the follow-up assessments if necessary.

Exclusion Criteria:

* Implantable pacemaker or cardiac defibrillator
* Unable to wear a virtual reality headset
Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension

This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign prostatic hyperplasia.


Eligibility Criteria:
Inclusion Criteria:

* Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
* Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments at any time during the study.
* Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to Visit 2.

Exclusion Criteria:

* Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.
* History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
* History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
* Clinical evidence of prostate cancer at Visit 1.
* Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
* History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
* History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
* Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
Antenatal Education Based on Improving Health Literacy

Aim: This study was aimed to evaluate the effect of antenatal education based on improving health literacy on the adaptation of pregnancy, general self-efficacy, fear of childbirth, and health literacy in primiparous pregnant women.

Design: It was a randomized controlled trial. Method: The research was carried out in a city located in the Marmara region of Turkey between July 2018 and April 2019. It was conducted with three groups, including one control (n=73) and two intervention groups (n=109). One of the intervention group was given antenatal education based on improving health literacy (n=53), and the other was only provided with antenatal education (n=56). Pregnancy Information Form, Prenatal Self-Evaluation Questionnaire, Pregnancy Related Anxiety Scale, General Self-Efficacy Scale, and Health Literacy-TR32 scale were used for data collection.

Background: Pregnant women get themselves ready to give birth, maternity and parenting through antenatal education. These trainings make it easier to adapt to the processes in which pregnant women experience change. They also provide an important opportunity to support and maintain the competence and motivation to manage health responsibility.

Aim: To evaluate the impact of antenatal education intervention based on improving health literacy in order for primiparous pregnant women to; accept the pregnancy and adopt the role of maternity; increase the level of general self-efficacy and health literacy; reduce the fear of childbirth; and support the level of breastfeeding.

Design: It is an experimental and randomized controlled trial. Method: The research was carried out in a town located in the Marmara region of Turkey between April 2019 and July 2018. It was conducted with three groups, including one control (73) and two training groups (109). One of the training group was given antenatal education based on improving health literacy (HL-AE) (53), and the other was only provided with antenatal education (AE) (56). Pregnancy identification form, prenatal self-evaluation questionnaire, pregnancy related anxiety scale, general self-efficacy scale, Turkey health literacy -32 scale and postpartum data collection form were used for data collection.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer primiparous pregnant women
* 18 years and over,
* No have any disease
* In the second trimester

Exclusion Criteria:

* Not participating in five-week education,
* Any complications developed during the education period
* Voluntarily leaving.
Observational Study on the Outcome of Patients With ITP Who Underwent Splenectomy After 2010

Retrospective data collection on ITP patients who underwent splenectomy from 01/01/2010 to 12/31/2022. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.

Observational, longitudinal, retrospective study on ITP patients. Patients with ITP who underwent splenectomy from 01/01/2010 to 12/31/2022 will be enrolled. All useful data will be collected exclusively through consultation of outpatient medical records. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years
* Patients with primary ITP according to international criteria \[2\], who underwent to splenectomy from 01/01/2010 to 12/31/2022.
* Obtaining Informed Consent.

Exclusion Criteria:

* none
A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement

Total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement. The study aims to compare total disc replacement to anterior fusion, sparing the muscles of the back and thus comparing the two different methods using the same surgical approach.

A total of 170 patients are planned to be enrolled in the study. If the patients meet the inclusion criteria and accept to participate they will be randomized to either anterior lumbar fusion or total disc replacement. The method of choice will be blinded for the patients until the two year follow up is completed.

Follow-up: after one and two years. Questionnairs: ODI, VAS, EuroQol, and GA Flexion- Extension X-ray after one and two years Complications will be retrieved from the patient journals.

Eligibility Criteria:
Inclusion Criteria:

* Patients with disabling pain from degenerative disc disease(DDD) both clinical and radiological, in one or two segments of the lumbar spine from L4-S1, were prolonged conservative treatment has failed.
* The patient should be able to understand swedish written and spoken.
* The patient should be between the ages 18-65. The patient has to accept to participate in the study

Exclusion Criteria:

* More than two degenerated segments.
* Degeneration above the L4 segment.
* Did not agree to participate in the study
* Previous history of tumor, vertebral fracture, infection, lumbar fusion and dominating leg pain.
* Need for posterior decompression
* Pregnancy
* Psychiatric illness or drug abuse
Test the Phototoxicity of Sunscreen Products

The primary objective of this study was to evaluate the potential for phototoxicity of the sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 compared to that of a negative control (0.9% sodium chloride \[NaCl\]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).

The secondary objective of this study was to evaluate the safety of the sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with UVA/B irradiation by monitoring adverse events (AEs) throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged 18 to 65 years
* Good general health, as assessed by medical history and brief visual examination of the skin
* Fitzpatrick skin Type I IV, determined by interview at screening
* Willing and able to practice an acceptable measure of contraception during the study, if female of childbearing potential
* Willing to follow study rules, which include: no sun exposure; avoidance of activities that would cause excessive sweating; and no use of lotions, creams, or oils on the back area
* Must be willing not to change current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, and body spritzes while participating in the study