cyrilzakka/clinical-trials huggingface dataset:
Melatonin and Radiation Therapy in Treating Patients With Brain Metastases

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as melatonin may make tumor cells more sensitive to radiation therapy and may protect normal cells from the side effects of radiation therapy.

PURPOSE: Randomized phase II trial to determine the effectiveness of combining melatonin with radiation therapy in treating patients who have brain metastases.

OBJECTIVES:

* Determine the effect of melatonin, used as radiosensitization/radioprotection, on overall survival and clinical deterioration in patients with brain metastases who are undergoing radiotherapy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo whole brain irradiation once daily 5 days a week for 2 weeks. Patients receive oral melatonin once daily every morning.
* Arm II: Patients undergo whole brain irradiation as in arm I. Patients receive oral melatonin once daily every evening.

All patients continue on melatonin for 6 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at months 6 and 12 from start of radiotherapy and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 128 patients (64 per treatment arm) will be accrued for this study within 5 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed solid tumor with brain metastasis

  * No germ cell tumors
* RPA class II with any of the following:

  * At least 65 years of age
  * Extracranial metastases
  * Uncontrolled primary malignancy
* Ineligible for or unwilling to participate in alternative RTOG stereotactic radiosurgery studies

PATIENT CHARACTERISTICS:

Age:

* See Disease Characteristics

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Able to swallow pills
* Not pregnant
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* More than 30 days since prior chemotherapy
* Concurrent chemotherapy after whole brain irradiation allowed

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* No prior radiotherapy to the brain

Surgery:

* Not specified
Traumeel S for Reduction of Post Operative Pain Following Arthroscopy

The perception of pain is a complex process that is not yet fully understood. With outpatient knee arthroscopy becoming standard of care, postoperative pain management has become increasingly important in caring for patients. Traumeel S is a homeopathic complex widely used in German-speaking Europe for orthopedic pain and inflammation. It contains a mixture of medicinal plants and minerals, all highly diluted. In some recent studies, Traumeel has shown anti-inflammatory and analgesic activity.

In this study, the efficacy of Traumeel S will be compared with placebo in reducing pain during the first 48 hours after arthroscopy. Also compared will be 6 day pain levels, analgesic consumption, quality of life, post operative knee function, quadriceps atrophy and safety.

The study design is double blind RCT. 98 patients, aged 18-40 and undergoing arthroscopic meniscectomy or chondroplasty will be enrolled in the trial. Patients will be randomized to receive either intraoperative join irrigation with Traumeel S and oral treatment with Traumeel S, or placebo irrigation and oral ingestion. Patients will continue to take active or placebo medication for 6 days. Pain will be recorded daily by the patient in the patient diary using an 11-point numerical rating score (NRS-11. Patients will also record daily consumption of primary and "rescue" analgesics. Range of motion (RoM) will be measured on days 6 and 30 post-operatively, and the Lysholm knee scale and circumference of thigh above patella will be measured at 30 days. All these measures will be compared with baseline. Patients will be contacted daily by the research assistant to encourage compliance and to record their daily NRS and analgesic consumption in the CRF.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex undergoing unilateral arthroscopy for menisectomy or chondroplasty, w/o ligament reconstruction .
* Age 18 - 40 years.
* Meeting none of exclusion criteria.

Exclusion Criteria:

* Participation in another clinical trial within 4 weeks prior to enrollment.
* Inability to comply with the study protocol.
* Impossibility to be reached during the whole follow-up period (7 days post operative)
* Refused to give oral consent to the telephone interviews
* Previous arthroscopy on ipsilateral knee.
* Current use of analgesia for any other reason except for the knee complaint.
* Any disease considered to inhibit wound healing (e.g. Diabetes mellitus, Berger, any PVD, DVT).
* Known sensitivity to dipyrone or diclofenac
Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)

The purpose of this study is to assess the safety \& efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause.

This is 12-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg and placebo capsules in subjects with moderate to severe postmenopausal VMS, defined as follows:

* Moderate VMS: Sensation of heat with sweating, able to continue activity
* Severe VMS: Sensation of heat with sweating, causing cessation of activity

The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Female, ≥ 40 years of age at screening (inclusive)
2. Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior to the screening visit
3. Spontaneous amenorrhea for at least 12 consecutive months or
4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause or
5. Bilateral salpingo-oophorectomy ≥ 6 weeks with or without hysterectomy

Exclusion Criteria:

1. Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS
2. History of self injurious behavior
3. History of clinical diagnosis of depression or treatment for depression
4. History of clinical diagnosis of borderline personality disorder
5. Use of an investigational study medication within 30 days prior to screening or during the study
6. Concurrent participation in another clinical trial or previous participation in this trial
7. Family of investigational-site staff
Cognitive Behavioral Therapy Delivered Over the Internet for Women With Postpartum Depression

This study will develop and test a Web-based program to treat women with postpartum depression.

After a woman gives birth, she will often feel anxious, depressed, or upset. For most women, these feelings go away within a week of giving birth, but for some, postpartum depression (PPD) can develop. PPD involves long-term, more severe feelings of anxiety, depression, and despair that impair normal functioning. Untreated PPD threatens both the mental health of mothers and the development of their infants, but many cases go untreated. This may be because of the stigma of mental health treatment, limited availability of programs, cost of treatment, or difficulty finding the time to schedule trips out of the home. Treatment through a Web-based program addresses all these concerns by providing a private, cost-efficient program available anywhere with computer access. This study will develop and test a Web-based version of cognitive behavioral therapy (CBT) to treat women with PPD to determine its feasibility and acceptability.

Participation in this study will last 3 months. All participants will be offered a Web-based version of CBT for PPD. The CBT program will include guided behavioral strategies for dealing with depression, online videos of women who have used these strategies, Web forums in which participants can ask questions of peers and experts, and periodic phone coaching. The program will last 6 weeks. All participants will complete assessments at baseline, post-treatment, and 3-month follow-up. Safety monitoring questionnaires will also be completed at Weeks 2 and 4 of treatment. Assessments will include clinical interviews and questionnaires related to the following: health; depression; demographics; maternal skills, stress, and self-efficacy; Internet use, experience, and self-efficacy; behavioral self-efficacy; and program acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Within 6 months postpartum
* Home access to the Internet
* Use of personal e-mail
* Score from 12 to 20, inclusive, on the Edinburgh Postnatal Depression Scale
* Diagnosed as having postpartum depression

Exclusion Criteria:

* Current diagnosis of substance abuse, bipolar disorder, or psychotic depression
* Currently receiving treatment for depressive symptoms, including antidepressant medication or psychotherapy
* Currently has suicidal intentionality, lethality, access to means, and history of suicide attempts
Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy

The MAPEC study was designed to investigate whether normalizing the circadian blood pressure profile towards a more dipper pattern (increasing the diurnal/nocturnal ratio of blood pressure) by the use of Chronotherapy (that is, taking into account the time of day of administration of antihypertensive medications) reduces cardiovascular risk.

Target organ damage is more closely associated with ambulatory (ABPM) than with clinic blood pressure (BP). In particular, the reduction of the normal 10 to 20% sleep-time BP decline (non-dipper pattern) is associated with elevated risk of end-organ injury, particularly to the heart, brain and kidney. These results suggest that cardiovascular risk could be influenced not by BP elevation alone, but also by the magnitude of the circadian BP variability. Moreover, at least two independent prospective studies have suggested that nighttime BP is a better predictor of risk than daytime BP. Common to all previous trials is that prognostic significance of ABPM has relied on a single baseline profile from each participant, without accounting for possible changes in the BP pattern, mainly associated to antihypertensive therapy and aging during follow-up. The MAPEC study investigates, first, the comparative prognostic value of several BP parameters (including, among many others, BP variability, the diurnal/nocturnal ratio, diurnal and nocturnal means, slope of morning rise, etc) in the prediction of cardiovascular morbidity and mortality; and, second, whether potential changes in the circadian BP pattern after Chronotherapy with antihypertensive drugs are associated to changes in cardiovascular risk.

Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension

Exclusion Criteria:

* AIDS
* shift workers
* secondary hypertension
* intolerant to ABPM
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)

The primary objective of this study is to evaluate the efficacy of BGB-DXP593 administered intravenously as a single dose in participants with mild to moderate COVID-19


Eligibility Criteria:
Key Inclusion Criteria:

1. Laboratory-confirmed severe acute respiratory syndrome (SARS)-CoV-2 infection (positive reverse transcription-polymerase chain reaction \[RT-PCR\] test or other authorized antigen testing methods) in any samples following local practice ≤ 72 hours prior to screening.
2. Have experienced COVID-19 symptoms for ≤ 7 days prior to treatment assignment, such as fever, cough, shortness of breath, sore throat, diarrhea, vomiting, and dysgeusia
3. Agree to the collection of nasopharyngeal swabs, saliva, and venous blood

Key Exclusion Criteria:

1. Severe COVID-19 having oxygen saturation (SpO2) ≤ 93 % on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) \< 300, respiratory rate ≥ 30/min, heart rate ≥ 125/min
2. Requires mechanical ventilation or anticipated impending need for mechanical ventilation
3. Known allergies to any of the components used in the formulation of the interventions
4. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
5. Have received treatment with a SARS-CoV-2 specific monoclonal antibody

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Effectiveness of Picture Exchange Communication System on Gingival Health of Children With Autism Spectrum Disorders

The Picture Exchange Communication System (PECS) is a communication system for children with autism spectrum disorders (ASD). The aim of this study was to assess the effect of a PECS-based tooth-brushing program on gingival health in children with ASD and assess parents' perception of PECS. This was a prospective interventional study. Using PECS as a pictures/cards series showing a structured tooth-brushing method, 37 children with ASD (31 males, 6 females) (average age 9.49±4.10, 4-16 years) and their parents/caregivers were trained on tooth-brushing twice, two weeks apart. Data collected after examinations (baseline, 3, 6-months) included gingival and plaque indices (GI, PI) and two questionnaires (baseline, 6-months) for demographic data and parents' perception of PECS including: difficulty rating (easy, hard, very hard) and PECS usefulness.

The need for improved oral hygiene routines in individuals with autism spectrum disorders (ASD) has been documented in many reports. The Picture Exchange Communication System (PECS), which is a series of pictures that show a structured method and technique for teeth brushing, was chosen for this study since it is a proven communication system for children with autism spectrum disorders (ASD).

The aim of the study was to assess the effect of a PECS-based tooth-brushing program on gingival health in children with ASD and assess parents' perception of PECS.

This was a prospective interventional study. Using PECS as a pictures/cards series showing a structured tooth-brushing method, 37 children with ASD (31 males, 6 females) (average age 9.49±4.10, 4-16 years) and their parents/caregivers were trained on tooth-brushing twice, two weeks apart. The pictures were placed in the bathroom, at home and/or at the autism center. Data collected after examinations (baseline, 3, 6-months) included gingival and plaque indices (GI, PI) and two questionnaires (baseline, 6-months) for demographic data and parents' perception of PECS including: difficulty rating (easy, hard, very hard) and whether they found PECS useful in teaching their children how to brush their teeth (yes or no).

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with ASD.
* Age between 4 and 18 years old.

Exclusion Criteria:

* Children unable to cooperate for data collection (poor behavior during dental examination).
Assessment of Temporomandibular Joint Function Across Different Trimesters of Pregnancy

This study will be conducted to assess Temporomandibular Joint (TMJ) function across different trimesters of pregnancy.

Pregnancy is a physiological state that can potentially influence the function and biomechanics of the Temporomandibular Joint (TMJ) due to hormonal changes, weight gain, and other associated factors. TMJ disorders are a common problem affecting a significant proportion of the population, with potential impacts on chewing, speaking, and other daily functions, significantly affecting a pregnant woman's quality of life.

Limited research has been conducted to comprehensively evaluate the changes in TMJ function and proprioception (repositioning accuracy) across different trimesters of pregnancy. By identifying and understanding the specific impacts of different trimesters of pregnancy on TMJ function, this study aims to provide insights that can help in the early detection and effective management of TMJ disorders. This, in turn, can improve the overall well-being and comfort of pregnant women, contributing to a more positive pregnancy experience.

Moreover, physiotherapists currently have limited guidelines specifically tailored for managing TMJ dysfunction in pregnant patients. This study aims to fill this gap by providing evidence-based insights into the mechanisms and risk factors associated with TMJ dysfunction during pregnancy. The findings can inform the development of clinical guidelines and therapeutic protocols that address the unique needs of pregnant women, ensuring safer and more effective care.

Eligibility Criteria:
Inclusion Criteria:

All women will be pregnant with a single baby. Their ages will range from 20 to 35 years old. Their parity will range from 1 to 2. Their body mass index will range from 20 to 30kg2.

Exclusion Criteria:

All women will not suffer from any TMJ disorder or orofacial pain before pregnancy.

All women will not suffer from any severe dental pathology. All women will not suffer from high-risk pregnancy (hyperemesis gravidarum, gestational diabetes).

All women will not suffer from any systemic illnesses.
Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder

This is a Post-Marketing Surveillance (PMS) of Abilify Maintena® Injections in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: Ministry of Food and Drug Safety(MFDS) Notification).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with schizophrenia or bipolar 1 disorder
* Patients who are prescribed Abilify Maintena® Injections treatment as per investigator's medical judgment
* Patients giving written authorization to use their personal and health data and starting Abilify Maintena® Injections treatment after agreement is in place and investigators provide the explanation about objective and feature of the surveillance

Exclusion Criteria:

* Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify Maintena® Injections
* Elderly patients with dementia related psychosis
* Patients who have been treated with Abilify Maintena® Injections
* Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the Clinical Global Impression-Severity(CGI-S)
* Patients participating in other clinical trial
* All patients who in medical judgment of the investigator would not be appropriate for inclusion criteria in the surveillance
Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients

The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.

In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined with endocrine therapy may improve the pathological remission rate.

Premenopausal patients with triple negative breast caner and hormonal receptor positve breast cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine therapy or not.

In this trial, patients with ER and or PR positive breast cancer will be separately randomized to have chemotherapy or chemotherapy combined with endocrine therapy according to their menstrual status. Letrozole for the postmenopausal women and ovarian function suppression for the premenopausal women. Patients with triple negative breast cancer will be randomized to have neoadjuvant chemotherapy combined with ovarian function suppression if she is premenopausal. Postermenopausal patients with triple negative breast caner will only have neoadjuvant chemotherapy.

Patients with Her2 overexpression can obtain anti-Her2 target therapy. This study has been amended to a 1:2 ratio to control and neoadjuvant chemotherapy combination of endocrine therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged ≥18years and ≤70 years;
2. At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-3M0;
3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as \>1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals \>2.0 or HER2 gene copy \>6.0.
4. No prior systemic or loco-regional treatment of breast cancer;
5. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL;
6. No obvious main organs dysfunction.

Exclusion Criteria:

1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;
2. Patient is pregnant or breast feeding;
3. Inflammatory breast cancer and metastatic breast cancer;
4. Any evidence of sense or motor nerve disorders;
5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;
6. Any concurrent malignancy other than breast cancer;
7. Know severe hypersensitivity to any drugs in this study.
Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study

The goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with in-breast recurrences after a previous lumpectomy and RT, investigators propose to test partial breast irradiation with the target volume encompassing the entire surgical bed with 1.0-1.5 cm margins.

Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for Radiation Therapy (RT) naïve patients at New York Presbyterian using EBRT.

The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.

Eligibility Criteria:
Inclusion Criteria:

* Isolated ipsilateral unifocal breast lesions
* Limited size (\< 2-3 cm) without evidence of skin involvement
* Histologically proven invasive breast carcinoma or carcinoma in situ
* Negative histologic margins of resection
* Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension
* No synchronous distant metastases
* Age ≥ 18 years
* ≥ 12 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence
* Technical feasibility
* Every kind of systemic therapy is allowed
* Informed consent for clinical and research purposes signed

Exclusion Criteria:

* Regional recurrences (axillary, supraclavicular)
* Positive histologic margins at resection
* Metastatic disease
* Poor cosmesis from previous surgery and RT
* Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment
* Extensive Intraductal Component