cyrilzakka/clinical-trials huggingface dataset:
Gabapentin For the Control of Hot Flashes in Women With Breast Cancer

RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes.

PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.

OBJECTIVES:

* Compare the effectiveness and side effects of 2 different doses of gabapentin vs placebo for the control of hot flashes and other vasomotor symptoms in women with breast cancer.
* Compare quality of life, anxiety, and depression in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and duration of hot flash symptoms (less than 9 months vs 9 or more months). Patients are randomized to 1 of 3 arms.

* Arm I: Patients receive oral placebo 3 times a day.
* Arm II: Patients receive oral gabapentin at a low dose 3 times a day.
* Arm III: Patients receive oral gabapentin as in arm II for 3 days and then at a high dose 3 times a day.

Treatment on all arms continues for 8 weeks in the absence of unacceptable toxicity. After week 8, patients may receive open-label gabapentin at the discretion of their physicians.

Hot flashes are assessed at baseline and then during weeks 3 and 7 of the study.

Quality of life, anxiety, and depression are assessed at baseline and then at weeks 4 and 8.

Patients are followed at week 12.

PROJECTED ACCRUAL: A total of 408 patients (136 per arm) will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Experiencing 2 or more hot flashes per day for at least 1 week
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* Not specified

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin normal
* SGOT no greater than 2 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 1.25 times ULN

Cardiovascular:

* No coronary insufficiency
* No myocardial infarction within the past 3 months
* No symptomatic cardiac disease
* No peripheral vascular disease
* No cerebrovascular disease or stroke
* No syncope or symptomatic hypotension

Other:

* No history of allergic or other adverse reaction to gabapentin
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 1 week after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No other concurrent anticonvulsant medication
* No concurrent clonidine or venlafaxine
Investigation of Functional Brain Network in Altered Meditation State With Multimodal Neuroimaging

The purpose of this study is to investigate functional brain network in altered meditation state with multimodal neuroimaging.

1. Recruiting participants by approaching mindfulness training, poster, and websites.
2. Completing Questionnaires, Tests, and other materials for experiments.
3. Examining Functional Brain Network of Internal and External Meditation of practitioners with a meditation using multimodal neuroimaging.
4. Collecting and evaluating data about the connection of internal and external meditation with multimodal neuroimaging and identifying the function related to meditation state.

Eligibility Criteria:
Inclusion Criteria:

* A sufficient level of education to understand study procedure and be able to communicate with site personnel.
* 18-60 years old.
* Interested in meditation.
* No metal or electronic implants in the body; no prosthesis (metal braces, dentures, etc.); no claustrophobia; no tattoos, piercings, etc.; no makeup on the day of the experiment.
* Right-handed.

Exclusion Criteria:

* The participant has a contraindication to MRI examination, such as claustrophobia.
* The participant is physically unfit for MRI, such as having a metal implant.
* The participant has a history of neurological or psychiatric disorders, or is taking any chronic medications that may interfere with the experiment.
Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

Recurrent aphthous stomatitis is a difficult to treat and quite common chronic inflammatory disease of the oral mucosa. This study evaluates the fluid extract from Chamomilla recutita's safety and effectiveness in treatment of aphthous stomatitis .


Eligibility Criteria:
Inclusion Criteria:• Confirmation of clinical diagnosis of aphthae

* Having the experience of oral aphthae at least once in a month
* Two weeks wash out periods after the last treatment

Exclusion Criteria:

* History of any systemic disease
* Using drugs which affect immune system
* Pregnancy and breast feeding
* Aphthous related syndromes
Evaluating the Safety of BONEBRIDGE Implants in Children Under Five Years Old: This Study Looks at Children Under Five Who Got BONEBRIDGE BCI 602 Implants. It Collects Information on Any Problems With the Device or the Surgery to See if it is Safe Within the First Year After the Operation.

This study, titled "The BONEBRIDGE in Children Under Five: Premarket Clinical Investigation" (Study ID 2023BB006), looks at kids under five who have received the BONEBRIDGE BCI 602 hearing implant. This observational study, which is both retrospective (looking back) and prospective (looking forward), will take place at multiple hospitals. The main goal is to see if the BONEBRIDGE implant is safe for young children within 12 months after surgery.

Primary Goal: The study's main aim is to collect all information about any bad experiences or issues related to the device and the surgery to check its safety.

Secondary Goals:

Hearing Improvement: Using tests like the Göttinger Speech Intelligibility Test (Word Recognition Scores) to see how much the hearing improves with the implant.

Treatment History: Surgeons will fill out questionnaires about how the treatment went.

Quality of Life: Parents will answer questions about their child's quality of life using the GCBI questionnaire at least 12 months after the implant.

The study will last up to 12 months, including enrolling participants and performing all necessary procedures. The target number of participants includes at least 12 sets of data for safety checks and at least 5 sets of hearing performance data.

By collecting detailed information on any problems and assessing the performance of the BONEBRIDGE implant, this study aims to determine if it is safe and effective for young children.


Eligibility Criteria:
Inclusion Criteria:

Children who received the BONEBRIDGE BCI 602 implant before the age of five and have had the implant for at least 12 months.

Ability to perform the German language test. Willingness and ability to undergo all tests required by the study. Signed and dated informed consent obtained before any study-specific procedure and collection of retrospective data.

Exclusion Criteria:

Inability to perform audiological tests due to psychological, emotional, or related physical disorders.

Failure to meet any inclusion criteria. Any condition that, in the investigator's opinion, poses an increased risk to the patient or prevents full compliance or completion of the study.
Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

The purpose of this study is to compare the effect of oral Diosmin to oral Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).

Two hundred women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for 2 weeks ; while in group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight days.

Eligibility Criteria:
Inclusion Criteria: infertile women undergoing intracytoplasmic sperm injection or polycystic ovarin syndrome (PCO) with one of the following:

1. Presence of more than 20 follicles by ultrasound
2. E2 more than 3000 pg/ml
3. Retrieval of more than 15 follicles

Exclusion Criteria:

* none
Comparison Between Atorvastatin and Rosuvastatin in Reduction of Inflammatory Biomarkers in Patients With Acute Coronary Syndrome

This study will help us to compare atorvastatin and rosuvastatin in terms of their ability to reduce biomarkers of inflammation in patients of acute coronary syndrome


Eligibility Criteria:
Inclusion Criteria:

1. Patients with age 18 years and above, of both genders, diagnosed with acute coronary syndrome (as per operational definition) who were not taking statins previously.
2. Patients who sign written informed consent to participate in the study.

Exclusion Criteria:

* 1.Patients who are taking either statins and/or any other drug which lower serum lipid levels, patients with a history of statin hypersensitivity, patients in whom statins are contraindicated.

  2.Patients who will be surgically managed will be also excluded. 3.if coronary revascularization will be planned or anticipated at the time of screening.

  4.Pregnant or lactating women. 5.Patients having concomitant infections which cause the rise of inflammatory markers.
An Observational Study of Current Practice Pattern on the Treatment of Women With Metastatic Breast Cancer Whose Tumors Overexpress Her2neu

The purpose of this study is to observe clinical outcomes of metastatic breast cancer patients whose tumors overexpress the Her2neu protein and are being treated with trastuzumab (Herceptin)either alone or combination with chemotherapy or hormonal therapy.

In clinical practice, patients with metastatic breast cancer are being treated either with trastuzumab alone or trastuzumab in combination with chemotherapy or hormonal therapy as it has shown to increase survival. There is currently minimal information as to how long trastuzumab should be given after disease progresses on trastuzumab. This study is a chart review of the above-mentioned population which will capture information such as;

* what chemo or hormonal therapies are chosen by clinicians for Her-2 positive metastatic patients to combine with trastuzumab
* what the number of treatment regimens are (chemo or hormonal) given with trastuzumab
* what the clinical outcome of patients treated is
* what happens to the patients cardiac status with long term administration of trastuzumab
* what treatment patterns exist in the management of central nervous system metastases

This study aims to generate a hypotheses that can be tested from the information collected after is has been analyzed to give clinicians further meaningful data to guide treatment decisions beyond treatment progression.

Eligibility Criteria:
Inclusion Criteria:

* patients must have metastatic breast cancer
* tumor must have been determined to be Her-2 positive 3+ by immunohistochemistry or gene-amplified by fluorescence-in-situ hybridization (FISH)
* must have received trastuzumab alone or in combination with chemotherapy or hormonal therapy
* must not have received trastuzumab in the adjuvant or neoadjuvant setting
* must have started trastuzumab treatment for metastatic disease any time between January 1996 to June 2003

Exclusion Criteria:

* patients who received trastuzumab prior to 1996
Resilience Measurement in Older Adults With Late-Stage Lung Cancer

The purpose of this study to test measures of physical and psychological resilience while using Self-System therapy (SST), to treat depression and lung-cancer-related distress in older adults (65 years and older).

The investigator will examine the feasibility of delivering measures of psychological and physical resilience while delivering the SST intervention. The investigator will also examine whether participation in SST can help alleviate symptoms of depression and distress while helping improve overall physical functioning in older adults with advanced lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* English-speaking
* The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at his/her home.

Exclusion Criteria:

* Unable to provide informed consent
* Visual or hearing impairments that preclude participation
* Serious mental illness
Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test

This is a prospective, single-center study that aims to evaluate the acute and delayed effect of exercise stress testing on the peripheral gene expression (PGE) levels using a predefined gene set established in the Corus CAD (Age/Sex/Gene Expression score - ASGES) test in subject with known obstructive coronary artery disease (CAD) and in control subjects (without known CAD).

This is a prospective, single-center study. This protocol is a pilot study to investigate the effects of "acute" exercise (by exercise stress testing; modified Bruce protocol) on peripheral gene expression (PGE) levels as measured by Corus CAD score (Age/Sex/Gene Expression score - ASGES). Subjects will have blood sampling at baseline, at peak exercise, within 30 to 60 minutes post-exercise, at 24-36 hours post-exercise. The study will be stratified by presence of CAD and gender. An equal number of subjects with known CAD and normal controls will be enrolled. Equally, an equal number of men and women will be included. A screening CBC and HgbA1c will be performed to ensure the subject meets the intended use instruction for Corus CAD (ASGES). Data collection will include presence or absence of ECG ischemia with testing, as well as heart rate and blood pressure response to exercise with other ECG and dynamic variables. There will be four blood samples taken per subject as shown in the figure below.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 45-75 years old
2. Able to perform an adequate exercise stress test
3. Subjects with no known CAD and subjects with known CAD subjects

Exclusion Criteria:

1. Known severe CAD that will be unsafe to exercise stress patient
2. Current MI or high-risk acute coronary syndrome (including high-risk unstable angina
3. NYHA class III or IV congestive heart failure
4. Severe regurgitant or stenotic cardiac valvular lesion
5. Severe left ventricular systolic dysfunction
6. Active systemic infection in the preceding 2 months or chronic infection (e.g. HIV, Hepatitis B or C, Tuberculosis)\*\*.
7. Protocol-specified rheumatologic, autoimmune or hematologic conditions
8. Known or suspected diabetes mellitus or documented Hemoglobin A1C (A test for people with diabetes that monitors their average blood sugar levels over a period of two to three months) percent within last 6 months; presume normal HgbA1c (used as a standard tool to determine blood sugar control for patients with diabetes.) if none documented.
9. Total WBC 11,000/ul from a CBC drawn within 7 days of enrollment
10. Inadequate exercise stress test.
11. Recipient of any organ transplant
12. Immunosuppressive or immunomodulatory therapy including any dose of systemic corticosteroids in the preceding two months
13. Chemotherapy in the preceding year
14. Major surgery in the preceding 2 months
15. Blood or blood product transfusion in the preceding 2 months
L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis

This study aimed to investigate the efficacy and safety of Pegaspargase together with liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as a salvage therapy for refractory Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients were older than 14 years of age
2. Diagnosed as EBV-Hemophagocytic Lymphohistiocytosis (HLH)
3. Patients did not achieve at lease partial response after initial treatment including HLH-94 or DEP no less than 2 weeks
4. Informed consent

Exclusion Criteria:

1. Heart function above grade II (NYHA)
2. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2
3. Pregnancy or lactating Women
4. Allergic to Pegaspargase, doxorubicin or etoposide
5. Active bleeding of the internal organs
6. uncontrollable infection
7. history of acute and chronic pancreatitis
8. Participate in other clinical research at the same time
Treatment of Alveolar Osteitis: Traditional or Regenerative?

Alveolar osteitis, commonly referred to as dry socket, is a common painful postoperative complication following tooth extraction. It is defined as pain in and around an extraction socket which increases at any time between one and three days following extraction, accompanied by partial or total loss of the blood clot from the socket, with or without halitosis (Blum, 2002).

The incidence of the complication varies from 1-5% for routine extractions up to approximately 30% for third molar extractions. There are a variety of factors that contribute to the incidence of dry socket including tissue trauma, smoking in the early postoperative period and the oral contraceptive pill. Although it is a self- limiting condition, symptoms can be very debilitating for patients and therefore following diagnosis, immediate treatment should be provided to expedite resolution and to their improve quality of life during the healing period. Treatment options for dry socket vary from rinsing of the socket, regular analgesia and sometimes placement of an obtundent, sedative dressing such as Alveogyl or a zinc oxide eugenol alternative.

This study will aim to compare two treatments for patients who present with alveolar osteitis (dry socket) to Dublin Dental University Hospital after tooth extraction. Following randomisation, one of two treatment modalities will be used, either a experimental treatment (Bio-PRF) or a positive control (Alveogyl).

The results of this study will enable us to learn more about the efficacy of these treatment options for dry socket and how they affect patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and females adults at least 18 years old
* A diagnosis of alveolar osteitis following tooth extraction based on patients having both pain and exposed bone
* Good command of the English language
* Willingness to keep a diary of symptoms and travel for the review appointment on day 7 following intervention

Exclusion Criteria:

* Pregnant or breastfeeding women
* Current or previous bisphosphonate used or history of radiotherapy to the jaws
* Allergy or intolerance to study materials
* Lack of capacity to consent to participate in the study
MPS II Immunophenotyping

The purpose of this study is to investigate how participant's body's immune system responds to idursulfase, an enzyme replacement therapy (ERT) and find out which types of immune cells are involved in causing untoward responses to the ERT so that the investigators can relate the level of immune response to the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a confirmed diagnosis of Mucopolysaccharidosis type II (MPS II) or Hunter Syndrome based on enzyme activity and variant analysis.
* Subject who plan to receive or have received enzyme replacement therapy with idursulfase.

Exclusion Criteria:

* None
Effect of Ulnar Styloid Fracture on the Outcome of Distal Radial Fractures Treated With External Fixation

Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient treated with external fixation.


Eligibility Criteria:
Inclusion Criteria:

* unstable distal radial fracture
* fixed with external fixator

Exclusion Criteria:

* multiple fracture
* open fracture
* nerve injury
* vascular injury
Quality of Life and Psychogenic Nonepileptic Seizures.

The goal of this study is to identify the prognostic factors of quality of life in patients with psychogenic non-epileptic seizures

This is a monocentric prospective study. Our main objective is to identify prognostic factors associated with an improvement of quality of life on the QOLIE-31 and Short Form Health Survey "SF-36" at six months from the diagnostic.

We hypothesized that the absence of PNES during the last three-months before the six months follow-up visit is the best prognostic factor for an improvement of quality of life All adult (\>15 years and 3 months) patients diagnosed with PNES will be prospectively included.

All patients will undergo standard of care and have consultation with neurologist and a psychiatrist trained for this type of disease, as it is usually made for these patients (no intervention allocated in the context of the research). . Announcement of diagnostic will be standardized and adapted to each patient. Clinical and demographic data will be collect as well as medical and psychiatric history. All patients will undergo prolonged electroencephalogram (EEG) under video monitoring allowing the diagnostic of PNES and ruling out epilepsy. Different neurologic and psychiatric scales will be collected (Quality of life in epilepsy - 31 quotes (QOLIE-31), Short Form Health Survey (SF-36), Montreal Cognitive Assessment (MoCA), Beck Depression Inventory (BDI2), Beck Anxiety index (BAI), Clinician administrated Post traumatic stress disorder scale (CAPS), Chilhood Trauma Questionnaire (CTQ), Epworth).

All patients will be oriented to psychiatric or psychological follow-up. Patients will undergo a one, three and six months follow-up and will be evaluated the number of seizure, their severity, and psychiatric or psychological follow-up will be evaluated. Patients will undergo scales (QOLI-31, SF-36, BDI2, BAI).

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults (15 years and 3 months old)
* Psychogenic nonepileptic seizures (PNES) diagnosed as "probable" , "clinically established" or "documented" according to "Lafrance and al." criteria
* Having benefited a prolonged electroencephalogram recording under video control
* Patient Information and collection of non-opposition (patient or legal guardian)
* The patient or caregiver will be able to perform reliably the crisis diary and make the difference between PNES and epileptic seizure after investigator or co-investigator information.
* Affiliated to a social Insurance...

Exclusion Criteria:

* Patients for whom PNES have not been diagnosed
* Refused to participate
* The patient or his caregiver isn't able to perform reliably the crisis diary and don't make the difference between PNES and epileptic seizure after investigator or co-investigator information