cyrilzakka/clinical-trials huggingface dataset:
Ovarian Cancer Patient Questionnaire on Genetic Testing

The objective of this study is to evaluate the willingness of patients with ovarian cancer to undergo genetic testing, given the cost, their understanding and acceptance of genetic testing and the possibility of targeted therapy.

All eligible patients being seen in the Gynecology Center at the M.D. Anderson Cancer Center and at Gynecologic Oncology of Houston for follow-up or a new diagnosis of ovarian cancer will be asked to participate in this study by completing a questionnaire.

This study will end when 400 completed questionnaires have been collected. We estimate that 40-60 ovarian cancer patients are seen in the Gynecology Center at the M.D. Anderson Cancer Center each week and that 20- 40 ovarian cancer patients are seen at Gynecologic Oncology of Houston each week. The completion of 400 questionnaires will provide adequate data to address our question in an expeditious time frame. The initial phase of this study is exploratory and does not involve a comparison group.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have the diagnosis of ovarian cancer.
* Patients must be at least 18 years of age at the time of enrollment.
* Patients must be able to read and write in the English language.

Exclusion Criteria:

* Patients that are unable to speak or write in the English language. Currently, the investigators' resources in genetic counseling are limited. In the future, they plan to expand the questionnaire and study to include additional languages.
* Patients having previously undergone BRCA genetic testing.
Growing Old at Home

The purpose of this study is to determine whether preventive home visits for people aged 80 and over are effective in the prevention of nursing home admission in Germany.

Regarding demographic changes in Germany it can be assumed that the number of elderly and the resulting need for long term care is increasing in the near future. It is not only an individual's interest but also of public concern to avoid a nursing home admission. Current evidence indicates that preventive home visits can be an effective way to reduce the admission rate in this way making it possible for elderly people to stay longer at home than without home visits. As the effectiveness and cost-effectiveness of preventive home visits strongly depends on existing services in the social and health system existing international results cannot be merely transferred to Germany. Therefore it is necessary to investigate the effectiveness and cost-effectiveness of such an intervention by a randomized controlled trial in Germany.

Eligibility Criteria:
Inclusion Criteria:

* older than 80
* fluent German speaker
* resident of Leipzig or Halle
* living at home (i.e. no nursing home resident)

Exclusion Criteria:

* cognitive impairment
* not able to give informed consent
* care level higher than 1 according to German long term care insurance
Individual Patient Expanded Access IND for Selexipag (Uptravi) in Participants With Non-healing Wound, Buerger's Disease

The purpose of this expanded access program (EAP) is to provide Selexipag (Uptravi) for the treatment of participant with non-healing wound, buerger's disease.


Eligibility Criteria:
Effect of Single Incision Versus Three Planned Incisions to Reduce Pre-operative Astigmatism After Phacoemulsification.

Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Pre-operative corneal astigmatism greater than 1.0 Diopter is reported in 42% preoperatively and 58%postoperatively after implanting a monofocal intraocular lens(IOL). Visual acuity tended to worsen postoperatively with increased astigmatism4. Different treatment modalities are used to reduce astigmatism, like toric IOL. Limbal relaxing incision, actuate keratotomy, intrastromal rings, Lasik and femtosecond laser. Most of these modalities are expensive, so they cannot be afforded by the patients as Pakistan is a low-income country with a per capita income of US$1,562 (160th worldwide)

According to the 2020 estimate, 33·6 million adults aged 50 years and older were blind with cataracts as a leading cause (15·2 million cases). According to Pakistan national blindness survey, cataract is the leading cause of blindness in Pakistan. Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Pre-operative corneal astigmatism greater than 1.0 Diopter is reported in 42% preoperatively and 58%postoperatively after implanting a mono-focal intraocular lens(IOL). Visual acuity tended to worsen postoperatively with increased astigmatism. Different treatment modalities are used to reduce astigmatism, like toric IOL. Limbal relaxing incision, actuate keratotomy, intrastromal rings, Lasik and femtosecond laser. Most of these modalities are expensive, so they cannot be afforded by the patients as Pakistan is a low-income country with a per capita income of US$1,562 (160th worldwide). Our study aims to compare the results of phacoemulsification cataract surgery with a planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian incisions ( group A) with convention supero-temporal 2.8 mm clear corneal incision(Group B) for the correction of postoperative astigmatism. We hypothesize that a planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian incisions ( group A) is better than conventional supero-temporal 2.8 mm clear corneal incision(Group B) for the correction of postoperative astigmatism at a significant level of 0.05.

Eligibility Criteria:
Inclusion Criteria: Cataract patients aged between 50 and 80 years having 1.0 diopters (D) or greater of regular corneal astigmatism documented by keratometry.

Exclusion Criteria:

1. Previous ocular surgery. 2. previous ocular trauma. 3. Pre-existing ocular disease. 4. High intraocular pressure (IOP) 5. Corneal opacity. 6. Strabismus 7. Amblyopia 8. Diabetes mellitus 9. Irregular astigmatism.

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Newborn Cranial Somatic Dysfunction - An Observational Study

Two prominent osteopathic physician researchers have studied cranial somatic dysfunction in newborns. Dr Viola Frymann published a paper in 1966 on the presence of somatic dysfunction involving 1250 infants. Dr. Jane Carreiro evaluated 1600 newborns in 1993 for cranial somatic dysfunction. This observational study is intended to continue their work in exploring the presence of cranial somatic dysfunction in newborns. The hypothesis is that there is an increased incidence of somatic dysfunction in newborns birthed by primigravid women and in newborns who experienced a longer second stage of labor.

100 newborns will be assessed for somatic dysfunction of the head, cervical, lumbar, and sacral areas. These findings will be compared to the findings of a standard newborn physical exam and the newborn and maternal history. These records will be reviewed for maternal age, parity, gravity, anesthesia during labor, and estimated gestational age. Birth history and initial newborn assessments will be reviewed for labor augmentation, duration of labor, length of second stage of labor, presence of instrumental delivery(vacuum extraction, forceps delivery, etc.), multiple birth, and presentation at delivery (breech, transverse, or compound presentation). The purpose of the study is to quantify the presence of somatic dysfunction in the newborn. We will assess any relationships between the identified somatic dysfunctions and factors present in the mother's and newborn's medical history.

Eligibility Criteria:
Inclusion Criteria:

* The infant must have been born at NRMC
* The infant must be greater than 6 hours old when enrolled
* The infant must be less than 72 hours old when enrolled
* The mother must volunteer to participate in the study

Exclusion Criteria:

* Born outside NRMC
* Infants who are critically ill will be excluded
* Infants with open spina bifida will be excluded
* Infants with a cleft lip will be excluded
* Infants with a cleft palate will be excluded
* Children who are wards of the state will be excluded
The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter

The goal of this observational trial is to study the effect of a laryngeal airway mask on the optic nerve sheath diameter, as a surrogate for intracranial pressure.

The optic nerve sheath diameter of participants will be measured under general anesthesia, before, during and after insertion of a laryngeal airway mask.


Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible to participate in this study, a subject must meet all of the following criteria: aged 18 years or older, ASA I or ASA II, scheduled for elective surgery under general anesthesia, with a planned duration of \> 30 minutes, that can be routinely performed with a LMA.

Exclusion Criteria:

* Scheduled for head or neck surgery
* Scheduled for neurosurgery
* Scheduled for laparoscopic or thorascoscopic procedures
* Scheduled for procedures that require Trendelenburg or anti-Trendelenburg positioning
* Neurological disorders
* Glaucoma
* History of bilateral eye related trauma
* Intellectual disability
Effect of Intermittent Pressure in Patients With PAD

The study will evaluate the effect of intermittent negative pressure (INP) on peripheral arterial disease (PAD) patient vascular function and blood flow. Patients will be given either -40mmHg INP or -10mmHg INP which will act as a placebo. Healthy volunteers will be given -40mmHg INP to evaluate changes in vascular function and blood flow with INP in healthy physiology.

Atherosclerosis occurs when blood supply to the lower limbs is restricted upon accumulation of fat in the arteries. Atheroslerosis in the lower limbs is termed peripheral arterial disease (PAD). The initial symptom is pain in the lower limbs followed by ulceration and gangrene. The literature has indicated that intermittent negative pressure (INP) can be used to reduce pain and facilitate wound healing. INP is a non-invasive technique that aims to increase arterial and skin blood flow in lower limbs and foot. This study aims to investigate the underlying mechanisms that are involved in changes in blood flow following application of INP. The Flow-Ox 'boot' will be used to apply INP for periods ranging from 4-8 weeks, for an hour twice per day, to the lower limb to determine the effects of INP on vascular function and blood flow. Specifically, vascular tests such as assessments of endothelial function, arterial stiffness, ankle-brachial pressure index (ABPI) and blood borne metabolic and inflammatory markers will be performed before and after INP application. A pain chart will be employed before and after INP application to determine whether there is any change in perception of pain felt by individuals who suffer from pain associated with lower limb arterial disease.

Eligibility Criteria:
Inclusion Criteria

PAD Patients:

* Age ≥ 18 years
* Attending vascular outpatient clinics or admitted in ward with PAD.
* ABPI \<0.9

Healthy Volunteers:

* Age ≥ 18 years
* No current or previous significant cardiovascular illness
* Able to give written informed consent

Exclusion criteria

PAD Patients:

* Unable to give written informed consent
* Patients with deep venous thrombosis
* Pregnant women

Healthy Volunteers:

* Positive medical history of: Vascular diseases such as PAD, stroke, IHD, hypertension... etc.
* Haematological conditions such as hypercoagulability, deep venous thrombosis... etc.,
* Alcohol excess
* Unable to give written informed consent
* Pregnant women
Online Surveys to Assess the Perception and Performance of Imaging and Associated Aspects

In this exploratory study, the researchers would like to investigate the background, perception, current use practices, potential unmet needs and/or challenges in regard to imaging procedures, imaging technology, or any other aspect related to the broader field of imaging.

The researchers plan to include volunteer participants to complete these surveys. The goal of these exploratory efforts will be to increase the currently very limited information available in the topics of interest stated above, and the findings, even if only from limited group of respondents, will help guide research development, prepare for design of clinical trials, guide special interest groups, and serve as role data for appropriate scientific publications.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who have access to the online survey tool and can read and write in English

Exclusion Criteria:

* None, as this is voluntary
IVF Outcome After Bariatric Surgery

This case-control study compares IVF results and live birth rates in women undergoing IVF with a history of bariatric surgery as compared to 2 age-matched control groups composed of (A) non-operated women matched on cases' post-operative BMI (controls 1) and (B) non-operated severely obese women (controls 2).

A preliminary study in the participating center showed a trend to lower ovarian response to stimulation and live birth rates after bariatric surgery compared to weight-matched patients. However, statistical significance was not reached, as the sample size was small.

The aim of the research project is to study the ovarian response and live birth rates of this bariatric surgery population, with a sufficient number of patients, in order to reach higher statistical power. This case-control study will involve 3 IVF (in-vitro fertilization) centers in France . All patients undergoing IVF with a history of bariatric surgery will be included from January 2012. Each case will be matched for BMI and age to the 2 next patients without bariatric surgery history and undergoing IVF and to one non-operated severely obese woman. Surgery procedures include sleeve gastrectomies and by-passes. The IVF results and live birth rates will be compared between the three groups.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing IVF and with a history of bariatric surgery
Non Interventional Study to Investigate the Safety and Effectiveness in Patients With Relapsed and Refractory Multiple Myeloma Treated With Elranatamab Under the Actual Use.

To investigate the safety and efficacy in patients with relapsed and refractory multiple myeloma treated with elranatamab under the actual use.

The objective of this study is to assess the safety and efficacy in patients with relapsed and refractory multiple myeloma (RRMM) treated with elranatamab under the actual use.

* Primary objective: Confirm whether the onset status (the number of patients, incidence, grade, seriousness, timing of onset, duration, treatment and outcome) of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) is comparable to that in the clinical studies and whether adverse reactions were appropriately treated.
* Secondary objective: Confirm the onset status of any adverse reaction (including unknown adverse reaction) to long-term treatment with elranatamab and the overall response (ORR) as efficacy assessment and evaluate them in terms of benefit-risk.

Conditions for approval; Because of the extremely limited number of patients treated in Japanese clinical studies, a drug use investigation in all patients should be conducted to understand the background information of patients on elranatamab, early collect data on the safety and efficacy of elranatamab, and take measures necessary for the proper use of elranatamab until the data of a certain number of patients are accumulated.

Eligibility Criteria:
Inclusion Criteria:

Patients who have received at least one dose of elranatamab.
Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants

This exploratory observational trial provides the opportunity to gather information on the effect of daily consumption of Poppi Apple Cider Vinegar Prebiotic Soda on gut health and digestion.

Individuals aged 18+ with a BMI under 30 and self-reported regular issues with IBS and/or poor digestion symptoms, including bloating, gassiness, heartburn, abdominal pain, constipation or associated symptoms (self-reported), but otherwise healthy will be chosen to participate in the study (see "4. Participant Definition"). Participants will be advised to discontinue any other oral supplement targeting the gut, including antibiotics, during the study and at least 3 months prior to.

Participants will be asked to complete the baseline survey on gut and skin health before the study starts.

Participants will also be asked to discontinue any additional soda consumption during the study.

Each day in the morning, for lunch, or in the afternoon, participants will drink one 12 fl oz. can of Poppi ACV prebiotic soda.

After 2 full weeks (day 14 of the study period) of drinking Poppi daily, participants will complete the 2-week follow up survey of gut and skin health.

After four weeks (day 28) of the study period, participants will complete the 4-week end-of-study follow up survey of gut and skin health. Making the whole study period four weeks.

The gut health surveys completed at baseline, week two and week four will be evaluated to determine the impact of Poppi ACV prebiotic soda on symptoms of poor gut health/digestion/IBS, including bloating, gas, heartburn, constipation and abdominal pain, as well as skin health.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-45
* Male or Female
* Must be in generally good health
* BMI under 35
* Self-reported issues with gas, bloating, heartburn/acid reflux, abdominal pain or digestion
* Willing to maintain their standard dietary pattern, activity level and body weight for the duration of the study

Exclusion Criteria:

* Severe chronic conditions, including oncological conditions or psychiatric disease
* Currently pregnant, wanting to become pregnant, or breastfeeding for the duration of the study
* Taking any prescription medication targeting the gut
* Taking any supplements targeting the gut in the past month
* Use of antibiotics in the past 3 months
Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance

BOSS-Trial I is a phase 2 clinical trial with the following objectives;

1. to prove the feasibility of a Bluetooth-equipped sphygmomanometer system in real-world clinical practice and wireless connection to the main server;
2. to prove the feasibility of the BP management strategy, including the pre-specified BP range, BP management algorithm, and behavioral; and
3. to gather information for the phase 3 trial including BP variability indices and their potentials as a treatment guidance.

* Elevated blood pressure is an established risk factor for recurrent stroke and vascular events in ischemic stroke survivors, but
* Current guideline (JNC VIII) has omitted or only partially covered a number of practical and important issues as follow;

  * When and how we measure blood pressure?
  * Is it justifiable to apply the same blood pressure threshold for office BP and home BP?
  * Should stroke survivors be treated by the same BP goal for non-stroke subjects?
  * Is it justifiable to apply the universal BP threshold for different mechanisms of ischemic stroke?
  * Is it really about only blood pressure or might it really be "beyond blood pressure?"
* Lifestyle modification should accompany all the pharmacological intervention but is usually in adequate to initiate behavioral changes.
* Frequent BP measurement at home will provide more detailed and reliable information than occasional office BP's.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke survivors within 7 days after onset
* ≥19 year-old male or female
* Medically and neurologically stabilized enough to take BP-lowering medication
* Mean systolic blood pressure ≥135 mm Hg during two days between at least 24 hours after onset and randomization (whether BP-lowering medication was prescribed or not)
* Capable of taking oral medication
* Capable of operating a wireless Bluetooth-equipped sphygmomanometer system and being expected to follow required procedures of the clinical trial
* Patients who provided written informed consent

Exclusion Criteria:

* Pregnant, puerperium ≤30 days or on breastfeeding
* enrolled in other interventional clinical trial
* Being transferred to rehabilitation center or institutionalized
* Being expected to have cerebral artery interventions within 3 months after randomization
* Known allergic reactions to olmesartan, amlodipine or hydrochlorothiazide
* Known severe hepatic disease
* Advanced kidney dysfunction requiring dialysis
* Being unlikely, in the opinion of the investigator, to comply with the clinical trial protocol or being unsuitable for any other reason.
Functional Limitation, Pain and Quality of Life in Patients With Cervical Spondylotic Radiculopathy

Radiculopathy is a neurological condition in which transmission along a spinal nerve and its roots is limited or inhibited. It is most caused by spondylotic changes such as cervical disc herniation leading to nerve root compression, inflammatory changes, and the formation of bony prominences in this region \[1\]. Pain is the initial symptom and cervical radiculopathy should be suspected when pain radiates from the neck to the shoulder and arm, accompanied by sensory complaints and motor weakness. It is most commonly caused by spondylotic changes, such as cervical disc herniation and bony prominences in this area, leading to nerve root compression and inflammatory changes. Stenotic changes in the spine, which are often observed with aging, can cause nerve damage and compression in individuals, causing radicular pain. However, there is insufficient study in which the relationship between pain caused by cervical spondylotic radiculopathy caused by stenosis and functional disability, disability and quality of life due to radiculopathy in patients is insufficient. In addition, the lack of a comprehensive outcome scale that evaluates the functional limitation caused by radicular pain has also led to a deficiency in the evaluation of functional limitation. In this context, CRES is a newly developed scale used to evaluate functional limitation associated with radicular pain. In this context, in this study, it was aimed to examine the relationship between pain, functional disability, disability and quality of life in patients with cervical spondylotic radiculopathy.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* with lateral-foraminal spinal stenosis in the cervical region
* with or without neck pain consistent with the diagnosis obtained from magnetic resonance imaging
* with unilateral root symptoms such as pain, numbness, weakness in the affected limb, and diagnosis based on MRI and computerized tomography

Exclusion Criteria:

* signs of increased ventral pressure, such as ventral osteophytes, disc calcification, and ligament hypertrophy
* severe neurological deficits, pregnant women, spinal malignancies,
* those who had undergone cervical surgery in the last 12 months
* and those who could not cooperate