cyrilzakka/clinical-trials huggingface dataset:
Pain Control in Patients With Recurrent or Metastatic Breast or Prostate Cancer

RATIONALE: An outpatient educational and behavioral skills training program may help patients with metastatic breast or prostate cancer live longer and more comfortably.

PURPOSE: This randomized clinical trial studies whether an outpatient educational and behavioral skills training program will improve pain control in patients who have metastatic or recurrent breast or prostate cancer.

OBJECTIVES:

* Evaluate the feasibility of implementing an outpatient education and behavioral skills training program for pain control in a multi-institution setting.
* Evaluate whether patient education and behavioral skills training improve cancer pain control in patients with recurrent or metastatic breast or prostate cancer.
* Amend the protocol, with the approval of the Division of Cancer Prevention and Control, to a groupwide 3-arm study if analysis demonstrates feasibility and potential efficacy of the patient education and behavioral skills training program.

OUTLINE: This is a randomized study. Patients are stratified according to diagnosis (breast vs prostate cancer), initial "pain worst" score (4-6 vs 7 or higher), and participating institution. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive standard pain management.
* Arm II: Patients receive educational intervention (booklets, audiotapes, and videotapes) and behavioral skills training (including a schedule of practice relaxation sessions) in addition to standard pain management. Patients receive a follow-up phone call within 48-72 hours of intervention to review pain status.

Patients on both arms undergo pain and psychological assessments on days 1 and 15.

PROJECTED ACCRUAL: A total of 96 patients (48 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Recurrent or metastatic breast or prostate cancer
* "Pain worst" score of 4 or greater on the Brief Pain Inventory
* No prior enrollment on this study (patients treated during the run-in period are ineligible for randomization)
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Menopausal status:

* Not specified

Performance status:

* ECOG 0-2

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No major psychiatric illness, including the following DSM-III-R diagnoses:

  * Bipolar disorder
  * Schizophrenia
  * Major depression
  * Multiple personality disorder
  * Psychotic disorder
  * Dementia
  * Outpatient status required

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 28 days since prior palliative radiotherapy to major site(s) of pain

Surgery:

* Greater than 30 days since prior surgery
Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact with Nature

Randomized clinical trial on the influence of intentional and indirect contact with nature on the immune response and affective states in people aged 50 years or older.

Interaction with nature creates a state of physical relaxation, helping the individual to manage stress and promote health. Along with the ability to reduce stress, nature has been shown to improve immune function in some specific environments. Science already proves that stress conditions affect the immune capacity, generating pathological immune responses and inflammatory responses inappropriate. Therefore, if contact with nature is capable of reducing stress, through this study can find manifestations of improvement of the functions immunological.

This clinical trial aims to analyze intentional (Forest Bathing) and indirect contact (e-NatPOEM) with nature. After informed consent form, participants will be randomized to the study arms. Will be evaluated cells and enzymes of the of the immune system and affective states immediately before the intervention, 30 minutes post intervention, and within 48 hours and four weeks after the intervention. The hypothesis of our study is that both nature-based interventions will stimulate the immune system and will improve affective states. However, intentional direct contact with nature will have superior results than indirect contact.

Eligibility Criteria:
Inclusion Criteria:

* individuals of both sexes
* capable of physical and mental to carry out the proposed activities
* capable of mental to fill in the questionnaires.

Exclusion Criteria:

* autoimmune diseases
* chronic or acute inflammatory diseases
* disease that affects the response of the immune system
* neuromuscular problems
* oncological diseases and neoplastic
* individuals being treated with immunosuppressive drugs or that affect the immune system
* individuals who are under the influence of alcohol or other substances that interfere with cognitive ability
* those who have had contact intentional relationship with nature in the 30-day period prior to participating in the study
Role of Melatonin Supplementation in Follicular Fluid of in Vitro Fertilization (IVF) Patients With Polycystic Ovarian Syndrome

To evaluate the effects of melatonin supplementation on the main in vitro fertilization (IVF) outcomes during ovarian stimulation in patients with Polycystic ovarian syndrome (PCOS).

Polycystic ovarian syndrome (PCOS) is a common endocrine disorder that causes infertility due to anovulation in women of reproductive age. Anovulation and also decreased oocyte and embryo quality may be cause of infertility in women with PCOS. Furthermore, the reactive oxygen species (ROS) induce oxidative stress which may be responsible for poor oocyte quality. The ROS generation from mononuclear cells is elevated in women with PCOS and a significant increment of lipid peroxidation products in women with PCOS has been reported.

Melatonin is a documented powerful free radical scavenger and a broad spectrum antioxidant. It has been observed that a non-PCOS group co-treated with inositol, folic acid, and melatonin (Inofolic Plus by LO.LI.Pharma) results in a significantly greater mean number of mature oocytes, and a lower mean number of immature oocytes in patients with low oocyte quality history when compared to treatment only with inositol and folic acid (Inofolic by LO.LI.Pharma).

The aim of the study is to evaluate the possible effects of melatonin supplementation on the main IVF outcomes during ovarian stimulation of patients with PCOS.

From July 2009 to December 2011, 358 patients with PCOS (Rotterdam criteria) were enrolled in this prospective randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PCOS
* irregular menstrual cycle (\> than 28-30 days)
* normal uterine cavity
* body mass index of 20 to 26 Kg/m2
* first IVF treatment

Exclusion Criteria:

* presence of tubal, uterine, genetics and male causes of infertility
* diagnosis of cancer
* hormonal treatment in the last six months
Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma

This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma
* Patients treated with inhaled corticosteroid and long acting beta 2 agonist
* FEV1(forced expiratory volume in 1 second)\>50% to 80%

Exclusion Criteria:

* Respiratory infection within 2weeks
* Asthma exacerbation within 6 weeks
Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients

To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as malignant lymphoma
* patients who were refractory to anthracycline or anthraquinone containing chemotherapy
* patients who are going to receive ESHAP or CHASE treatment regimen
* ECOG performance status =\< 2
* patients who have appropriate bone marrow, hepatic and renal functions
* written informed consent

Exclusion Criteria:

* double cancer
* history of bone marrow transplantation or PBSCT
* more than 2 prior chemotherapy regimens
* primary hematologic disease such as myelodysplastic syndrome
* previous radiotherapy within 4 weeks of enrollment
* woman of childbearing potential who were either pregnant, breast feeding
* patients who participated in other clinical trials within the last 4 weeks of enrollment
Mepitel Film Treatment for the Prevention and Cutaneous Toxicity Due to Radiotherapy

This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity due to radiotherapy in patients with post-surgery breast cancer.

Mepitel film will be placed on the skin of the patients just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of toxicities.

For patients randomized in the mepitel arm:

Mepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with mepitel.

For patients randomized in the standard of treatment arm:

Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine o Ialugen Plus) cream in case of skin erythema. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients with breast cancer treated with conservative surgery who need radiotherapy treatment
* capability and willness to participate to the study
* informed consent form signature

Exclusion Criteria:

* contraindication to the correct placement of the Mepitel Film
* previous breast radiation treatment
* participating in other clinical trials
* previous breast reconstruction
* concomitant treatment with antiblastic chemotherapy
Biosimilar Versus Urinary Gonadotropins

Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another step in simplifying fertility treatments, making them easier to manage and more accessible to patients. Taking in mind these arguments ,the study is proposed for determining equivalence in terms of biological effectiveness of an ovarian stimulation protocol with biosimilar recombinant FSH stimulation protocol vs. urinary FSH in oocyte donation program.

Biosimilar products are drugs "like" biotechnological origin to other innovative biological medicines and that can be marketed once the patent has expired. These drugs are intended to achieve the same therapeutic benefit as biological medicinal resembles.

Because of the similarity in both the active substance in the formulation, it is intended to demonstrate the equivalence between the biosimilar medicine of recombinant FSH and FSH of urinary origin in terms of fitness.

The investigators' main objective is to perform a non-inferiority trial of biosimilar recombinant FSH product compared to a conventional ovarian stimulation protocol with urinary FSH in relation to the number of oocytes retrieved and the number of metaphase II oocytes.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-35 years who meet the criteria for entry into the oocyte donor program and that are going to undergo controlled ovarian stimulation

Exclusion Criteria:

* Patient with a basal antral count\> 20 follicles in total or \<6 antral follicles per ovary
* Patients with comorbidities that, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation
* The presence of ovarian cysts that judgment of the investigator would interfere with the stimulation or may pose a risk to the donor
* BMI \<18 kg / m2
* BMI\> 30 kg / m2
* Severe hypersensitivity to drugs with similar structure
Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

Over the past 10 years, there are a large number of dietary treatments related to the CD, such as specific carbohydrate diet, low Fermentable Oligo-, Di-, Mono-saccharides And Polyols (FODMAP) diet, and allergen-free foods. But there is no consistent conclusion or convincing evidence about the effectiveness. Through the long-term clinical experience observation, we find most of the CD patients can get stable remission by removing refined food and intolerance food.This project aims at developing a new dietary therapy suitable for Chinese patients.

The dietary therapy is based on the nutrient composition of exclusive enteral nutrition and is more in line with Chinese patients' dietary habits and economic conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnose CD according to endoscopy, histology and imaging;
2. Bowel resection for CD
3. Oral nutritional preparations or food can be given after surgery

Exclusion Criteria:

1. Plan operation within 5 weeks after surgery;
2. Presence of an ileostomy or colostomy
3. Complete bowel obstruction or fibrous stricture
4. Pregnancy or breastfeeding;
5. Plan to use biological agents within 5 weeks after surgery;
6. Plan to use corticosteroids or prednisone greater than 20 mg per day or equivalent doses of drugs to maintain remission within 5 weeks after surgery;
7. Plan to use probiotics or prebiotics for more than 1 week after surgery;
8. Antibiotics are used for more than 2 weeks after surgery;
9. Hypersensitivity to known components of enteral nutrition;
10. BMI less than 14 or greater than 28 kg/m2;
11. Celiac disease;
12. Complicated with other autoimmune diseases such as diabetes or rheumatic disease, autoimmune liver disease, psoriasis;
13. Mental illness;
14. Malignant tumors
15. Those who are not suitable for body composition analysis (such as pacemakers and metal objects in the body)
16. Participating in other clinical trials
17. The researcher believes that others are not suitable to participate in this study.
Evaluation of Perioperative Celecoxib for Hip Arthroscopy

Celecoxib is commonly used for perioperative pain control for certain orthopaedic procedures. It has been shown to be successful in assisting in pain control for knee arthroscopy. It has not previously been studied in hip arthroscopy. This is a double blinded randomized controlled trial to determine the efficacy of celecoxib in perioperative pain control for hip arthroscopy.

This study examines the efficacy of perioperative dose of celecoxib in pain management after hip arthroscopy. Perioperative administration of celecoxib has been shown to improve pain control after knee arthroscopy, but this has not yet been studied in the hip. In this study, patients are randomized to receive either 400mg celecoxib or placebo 1 hour prior to undergoing hip arthroscopy surgery. Postoperatively, patients are monitored for pain on the VAS scale, narcotic use, and meeting discharge criteria. The study will enroll 100 patients. Patients are approached for informed consent on the day of surgery. Pain scores, narcotic use, and time to discharge in the celecoxib group are compared to the placebo group.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are undergoing a hip arthroscopy procedure at Northwestern Memorial Hospital with Dr. Michael Terry.

Exclusion Criteria:

* Pregnant women and any patient under the age of 18 years.
30-Days Post-Operative Complications in Bariatric Surgery

comparison of 30-days post-operative outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB)

Obesity is one of the most challenging chronic diseases in the western world as well as in Pakistan. Half of the people in this world consider themselves overweight or obese. Obesity is one of the most challenging chronic diseases in the western world as well as in Pakistan . Half of the people in this world consider themselves overweight or obese. Obesity is challenging to control by medical therapy and drug treatment. The most effective way to treat obesity is bariatric surgery. Laparoscopic Roux-en-Y gastric bypass (LRYGB) is a "gold standard" bariatric surgical procedure. Recently there is much attention gained by laparoscopic sleeve gastrectomy (LSG). Therefore, we decided to conduct this comparative study to compare the early post-op complications of LSG with LRYGB technique in patients undergoing bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients of age 18 to 65 years
* body mass index (BMI) \>35 kg/m2 (Morbidly obese)
* Patients with failed conservative treatment of weight control

Exclusion Criteria:

* Severe indicative gastroesophageal reflux disease (GERD)
* Conversion of another bariatric procedure
* Large hiatal hernia
* Patients with inflammatory bowel disease
Radiologic Features of Invasive Pulmonary Aspergillosis

Invasive pulmonary aspergillosis (IPA) is an opportunistic infection that primarily affects recipients of solid organ transplants (SOTs) and patients with chemotherapy- induced neutropenia.Although both of these populations are at high risk for IPA, they differ with regards to the specific defects in host defense mechanisms that increase their risk for IPA. Chemotherapy- induced neutropenia is the principal defect affecting patients with hematologic malignancies, whereas transplant recipients tend to have dysfunctional T cells and phagocytes, as a result of immunosuppressive drug therapy. Thus, the patterns of IPA-related infection and inflammation may differ according to the type of underlying immune defect. Although the clinical and radiological features of IPA in patients with neutropenia have been extensively studied, little is known about the characteristics of IPA in SOT recipients. The investigators therefore compared the IPA- related clinical and radiological findings in SOT recipients with those of neutropenic patients.


Eligibility Criteria:
Inclusion Criteria:

* IPA cases with solid organ transplant recipients and hematologic disease patients
* proven and probable invasive pulmonary aspergillosis by modified EORTC/MSG criteria

Exclusion Criteria:

* under 16 years old
* possible cases of invasive pulmonary aspergillosis
Treating Postmenopausal Dyspareunia Where it Hurts

The purpose of this study is to compare the effectiveness of two low doses of estrogen cream applied to a new location for the treatment of moderate or severe pain during sexual intercourse in postmenopausal women.

Estrogen cream is FDA-approved for vaginal use for the treatment of sexual pain, but its use in a new location is experimental. Pain with sex is a common problem experienced by women after menopause and the relationship of pain to sexual difficulties is well established. The cause has been assumed to be atrophy and the location has been assumed to be the vagina. Recent focused studies have shown that the location of pain is the vulvar vestibule and usually not the vagina. This study will look at pain before and after therapy with estrogen when only the vulvar entryway area is treated. This will be a study focused on sexual dysfunction in postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women aged 40 to 70 years old.
2. Postmenopausal, demonstrated by at least one of the following:

   i. Cessation of menses for ≥1 years if age is \>50 ii. Bilateral oophorectomy iii. A history of climacteric symptoms if below age 50, having an ovary and scarred or absent uterus.
3. Onset of dyspareunia after menopause.\*
4. Stable heterosexual partnership ≥2 years (or by investigator discretion if less than 2 years) and both partners want to have more satisfying penetrative intimacy.
5. No estrogen product use, local or systemic, for 6 months.\*
6. More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).\*
7. Willingness to enter a study where she will receive low-dose local estrogen.\*
8. Willingness to enter a study that requires application of cream on a frequent schedule for 3 months. \*
9. Willingness to evaluate the progress of therapies by use of the Tampon Test as many as 2 times per week, and willingness to attempt intercourse if the Tampon Test indicates tolerable penetrative pain.\*

   * n/a for reference group

Exclusion Criteria:

1. Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
2. Negative cotton-swab touch test in the vulvar vestibule or vestibular tenderness that is not extinguishable by application of lidocaine 4% topical solution applied for 3 minutes.
3. Partner with sexual dysfunction limiting his performance or making it inconsistent. (The use of male therapy for erectile dysfunction is acceptable.)
4. Diagnosis by a physical therapist or clinician of significant pelvic floor muscle tension causing pain (pelvic floor myalgia) or has been found on screening examination to have pelvic floor tenderness or bladder tenderness.
5. Constant burning pain localized to the vulva.
6. Allergy to local estrogen products or lidocaine numbing agents.
7. Previous estrogen receptor positive breast cancer or endometrial cancer.
8. Endometrial thickness ≥5mm on screening via transvaginal ultrasound.
Impact of a School- and Primary Care-based Multicomponent Intervention on HPV Vaccination Acceptability

This study aims at evaluating the effectiveness, efficiency and implementation of a multicomponent intervention (components being applied in combination or alone) on the acceptability of HPV vaccine among French adolescents (11-14 years old) through a cluster randomized controlled trial. The primary outcome to measure acceptability is vaccine coverage. The three components are: adolescents and parents' education and motivation at school (component 1); general practitioners' training (component 2); and access to vaccination at school (component 3). Ninety municipalities are included and randomized into six groups of 15 municipalities, according an incomplete factorial plan.


Eligibility Criteria:
Adolescents and parents' education and motivation at school (component 1 -- arms 1-4) and "KABP-6C" survey among adolescents and parents (arms 1-6)

Inclusion Criteria:

* Adolescents (school years 9-10), and parents of adolescents (school years 7-10) attending secondary schools in the participating municipalities.

Exclusion Criteria:

* /

General practitioners' training (component 2) and "KABP-6C" survey among general practitioners (arms 1, 2 and 5)

Inclusion Criteria:

* General practitioners' practicing in the participating municipalities.

Exclusion Criteria:

* Exclusive particular type of practice.
* Planning to retire or move their practice within the study period.
* No internet access.

Access to vaccination at school (component 3 -- arms 1 and 3)

Inclusion Criteria:

* Adolescents (school years 7-10) attending secondary schools in the participating municipalities, aged 11-14 years (with a possible catch-up for those aged 15-19 years according to the French recommendations).

Exclusion Criteria:

* Having initiated HPV vaccination.
* No written consent from parents/caregivers for vaccination.
* Contraindication to HPV vaccination.