cyrilzakka/clinical-trials huggingface dataset:
Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer

This protocol will evaluate the feasibility and toxicity of dose-dense docetaxel followed by doxorubicin and cyclophosphamide with support given as adjuvant or neoadjuvant treatment of women with node positive and high risk breast cancer

Upon determination of eligibility, patients will receive:

Neoadjuvant Docetaxel + Doxorubicin + Cyclophosphamide + Surgery

Adjuvant patients will enter the study after surgery and receive Docetaxel+ Doxorubicin + Cyclophosphamide. Patients treated with lumpectomy will undergo postoperative radiation therapy after completion of chemotherapy. Patients with positive estrogen and/or progesterone receptors will begin anti-estrogen therapy after the last course of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Histologically proven breast cancer
* Females, age greater than 18 years
* Ability to perform activites of daily living with minimal assistance
* Normal cardiac function
* Adequate bone marrow, liver and kidney
* Signed informed consent prior to beginning specific protocol procedures

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Prior systemic anticancer therapy for breast cancer
* Prior anthracycline or taxane based chemotherapy for any malignancy
* Pregnant or breast-feeding women.
* Pre-existing moderate to severe motor or sensory neurotoxicity
* Other serious illness or medical condition

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life

The aim of this study was to investigate the quality of life (QoL) for women with breast cancer in Taiwan after using the BCSMS App.

After receiving their first diagnosis of breast cancer, women with stage 0 to III were randomized into intervention and control groups. Intervention group subjects used BCSMS App and the control group subjects received usual care. Two questionnaires: EORTC QLQ-C30 and EORTC QLQ-BR 23 were distributed to subjects in both arms at baseline and at 1.5 and 3 months. All evaluations were anonymous.

Eligibility Criteria:
Inclusion Criteria:

* first diagnosis of breast cancer with stage 0 to III in past year.
* aged 20 to 65 years
* had an Android/iOS smartphone;
* able to read and write in Chinese;
* willing to participate in the study and provide informed consent.

Exclusion Criteria:

* not matched to inclusion criteria
* mental illness
* serious illness and life-threatening
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)

This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).

This is a randomized, double-blind, placebo-controlled study that assessed the safety efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH). Patients who meet the criteria for Study CORT118335-860 were randomized on Day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12 weeks.

Due to observations related to safety, the study was terminated prior to completion and study objectives, endpoints, and procedures were modified as specified in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of NASH based on a biopsy obtained within the last year OR
* Have a diagnosis of presumed NASH based on blood tests and scans

Exclusion Criteria:

* Have participated in another clinical trial within the last year and received active treatment for NASH
* Have participated in another clinical trial for any other indication within the last 3 months
* Are pregnant or lactating women
* Have a BMI \<18 kg/m\^2
* Have had liver transplantation or plan to have liver transplantation during the study
* Have type 1 diabetes or poorly controlled type 2 diabetes.
Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects

The aim of this study will be to evaluate, clinically, and radiographically the effect of Nigella Sativa oil extract Mixed with xenograft versus xenograft alone in the treatment of intra-bony defects in patients with aggressive periodontitis.

in 10 patients, twenty sites in subjects with, localized aggressive periodontitis, with CAL ≥ 5 will be included in the present study. Sites will be allocated randomly to be surgically treated with, Nigella Sativa oil extract Mixed with xenograft or xenograft alone. At baseline, 3, 6 after surgery, the following clinical parameters (PD, CAL, BOP) and CBCT at baseline and 6 months x-ray will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy patients were selected

  * patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
  * Patients should demonstrate their ability to maintain good oral hygiene

Exclusion Criteria:

* • Smokers and pregnant patients.

  * Medically compromised patients and systemic conditions precluding periodontal surgery.
  * Subjects who do not comply with oral hygiene measures as evidenced in recall visits.
  * Restoration or caries in the site to be treated or non-vital tooth
  * Restoration or caries in the site to be treated or non-vital tooth
Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure

Premature ovarian failure (POF) is known to be associated with an increased risk of ocular surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen in this condition. From preliminary data, we suspect that women with Turners syndrome (45, XO), a genetic abnormality that affects sex hormone levels, are also at increased risk of ocular surface disease. Comparing POF and TS women may allow us to distinguish different mechanisms for ocular surface disease, due to the different etiologies of hormonal (estrogen and androgen) alterations posed by POF and TS.

Premature ovarian failure (POF) is known to be associated with an increased risk of ocular surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen in this condition. From preliminary data, we suspect that women with Turners syndrome (45, XO), a genetic abnormality that affects sex hormone levels, are also at increased risk of ocular surface disease. Comparing POF and TS women may allow us to distinguish different mechanisms for ocular surface disease, due to the different etiologies of hormonal (estrogen and androgen) alterations posed by POF and TS.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Ability to understand and give informed consent.
  2. Meet the diagnostic criteria for TS (45, X0) or premature ovarian failure OR age matched control for study participant with TS or POF.
  3. For non Turner syndrome subjects only - Negative pregnancy test or post menopausal status for greater than or equal to 1 year.
  4. Karyotype of XO for TS subjects or XX for POF and age matched control subjects.

EXCLUSION CRITERIA:

1. Persons less than 18 years old.
2. Persons with ophthalmic diseases associated with ocular surface disease.
3. Hyperprolactinemia.
4. Cushing s syndrome.
5. Other endocrine disorders which impact sex steroid hormones.
6. AIDS
7. Pregnancy or lactation.
8. For age matched control population ONLY- complaints of dry eye.
9. For age matched control population ONLY- oral contraceptives or menopausal hormone therapy or any medications which alter sex hormone levels in the blood or chronic usage of medications that induce dry eye.
LIKEST Study: Lipocet® in Adults With Primary Knee Osteoarthritis Grade 3-4

The purpose of this study is to assess the safety, tolerability and efficacy of Lipocet® (food supplement) in patients with primary knee osteoarthritis grade 3 - 4

After being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. Patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Lipocet ® (once a day, 10 ml corresponding to 1500 mg of Cetylated fatty acids) or placebo (once a day, 10 ml) during 60 days of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Signed Patient Information Sheet and Informed Consent Form
2. Patients with primary osteoarthritis classified according to ACR/EULAR criteria
3. Men or women aged ≥ 40 and ≤80 years
4. A disease severity grade 3 or 4 according to the Kellgren-Lawrence classification:

   * grade 0 (none): definite absence of x-ray changes of osteoarthritis
   * grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping
   * grade 2 (minimal): definite osteophytes and possible joint space narrowing
   * grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends
   * grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends
5. Patients who are candidates for knee replacements can be included (this criterion is not mandatory)
6. Patients who mark the pain ≥ 4 cm on a VAS
7. Patients who are willing or able to follow doctor's instructions
8. Patients not participating in other clinical trials within 30 days before the screening
9. Patients who have received sufficient explanation for this clinical trial and agreed to participate

Exclusion Criteria:

1. BMI \> 32
2. Systemic inflammatory diseases (e.g. fibromyalgia, etc.)
3. Progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
4. Patients with major infections in the observation period
5. Renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values)
6. Liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal
Gut Microbiome Mediated Effects of Inulin Supplementation on Mineral and Bone Metabolism in Hemodialysis Patients

The overall objective of the study is to examine the changes within the gut microbiome after the supplementation of inulin and its effect on markers of mineral metabolism and bone turnover.

In this randomized controlled cross-over study, twenty HD patients (10 male/10 female, aged 20-80) will be recruited from local dialysis clinics in Champaign-Urbana, IL. After baseline testing, patients will be randomized to the intervention group or placebo group (maltodextrin). Patients will consume inulin (females 10g/day, males 15g/day) or maltodextrin (females 10g/day, males 15g/day) for one month, rest for two weeks (washout period), and continue with the other treatment (either inulin or maltodextrin) for another month. Outcomes will be assessed at the beginning of each period and after a month of supplementation at both periods.

Eligibility Criteria:
Inclusion Criteria:

* Receive HD therapy 3 days per week and for at least 3 months

Exclusion Criteria:

* Sustained hypercalcemia (\>3months).
* Previous major gastrointestinal disease diagnosis (e.g., inflammatory bowel disease and celiac disease).
* Antibiotic treatment \< 2 weeks prior the start of the study.
Amniotic Membrane Visio-AMTRIX in Recurrent Macular Hole

The purpose of this open, multicenter trial is to assess the impact of the use of an amniotic membrane graft on the closure of macular hole-associated retinal detachment in patients with failed previous macular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman over 18 years of age, less than 75 years
* Macular Hole of all etiologies
* Patient with history of opened macular hole after previous pars plana vitrectomy
* Delay between previous surgery and inclusion (relapse or non-closing hole) \> 1 month
* Patient who received the study information and provided consent
* Patient who is a members or a beneficiary of a national health insurance plan

Exclusion Criteria:

* Ocular surgery other than the macular hole surgery in the prior 3 months
* Participation in other clinical studies in the prior 3 months
* Any current or prior ocular pathology that could interfere with the conduct of the study, including visually significant cataract or media opacity
* Patient with uncontrolled glaucoma on more than 1 intraocular lowering medication
* Patient with uveitis or other active ocular inflammation or infection
* Pregnant or breast-feeding woman. Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study or to use an effective birth control method
* Person deprived of liberty by judicial or administrative measures
* Any other reason which in the opinion of the investigator would preclude the adherence of the schedules visits, safe participation in the study or affect the results of the study
Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars

The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the treatment of fresh surgical scars.

Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars. This is a single-center prospective, randomized, open-label, pilot study of a novel 532 nm KTP Laser in comparison with the 595nm pulsed-dye laser (PDL) in up to 20 subjects who have had a fresh surgical scar acquired within one to twelve months of the screening visit.

Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type I - IV
* Has postoperative linear scar(s) which is one to twelve months post-surgery.
* Having one scar that measures a minimum of 5 cm in length or two scars (bilateral) each measure a minimum of 2 cm in length.
* Be in good health.
* Must agree not to undergo any other procedure for the treatment of scar during the study.
* Willing to refrain from excess sun exposure and willing to wear sunscreen on the treated scar during the study (including the follow-up period).
* Able to read, understand and sign the Informed Consent Form.
* Willing and able to adhere to the treatment and follow-up schedule, and the post-treatment care instructions.
* Willingness to have digital photographs taken of the treated scar.
* Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.

Exclusion Criteria:

* Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
* Having received any prior treatment for the target surgical scar.
* Pregnant and/or breastfeeding.
* Significant concurrent illness, malignant tumors in the target area, acute or chronic skin infection/inflammation, currently using immunosuppressive medications or currently undergoing systemic chemotherapy.
* Current use of any medication known to increase sensitivity to light or taking prescription anticoagulation medication.
* History of abnormal or delayed wound healing, keloid formation or pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
* History of malignant skin disease, immune deficiency disorders, coagulation disorders, seizure disorders due to light, or diseases stimulated by heat, unless prophylactic measures taken prior to treatment.
* Systemic use of isotretinoin within 6 months or corticosteroids within 12 months of study participation.
* Anytime in life, had used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
* Current smoker or history of smoking within 12 months of study participation.
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia

The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18 years of age or older.
* Subjects with Chronic Phase Ph+ CML.
* Subjects have not been treated with imatinib at a dose \>600 mg/day.
* Subjects developed resistance to disease while receiving an imatinib dose 400-600 mg/day.
* Able to tolerate imatinib at the highest dose the subject had received in the past.
* Demonstrate adequate renal and hepatic function.
* Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception.

Exclusion Criteria:

* Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period for a least 1 month before and at least 3 months after the completion of the study.
* Women using a prohibited contraceptive method.
* Women who are pregnant or breastfeeding.
* Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above.
* Prior treatment with imatinib at a dose \>600 mg/day.
* Subjects who have previously identified specific BCR-ABL mutations.
* Previous diagnosis of accelerated phase or blast crisis CML.
* Intolerance to imatinib at any dose.
* Subjects who are eligible and willing to undergo transplantation during the screening period.
* Serious uncontrolled medical disorder or active infection.
* Uncontrolled or significant cardiovascular disease.
* Uncontrolled hypertension.
* Dementia or altered mental status.
* Evidence of organ dysfunction.
* Use of imatinib within 7 days.
* Use of interferon or cytarabine within 14 days.
* Use of a targeted small molecule anticancer agent within 14 days.
* Subjects taking certain medications that are accepted to have a risk of causing Torsades de Pointes.
* Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
* Prior therapy with BMS-354825.
Adherence Risk Indicator Validation Study

While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally. The adherence risk indicator (ARI) is a statistical model based on answers from a questionnaire. The data collected from this trail allows for closer monitoring of at-risk patients. For the study, participants are provided with a questionnaire prior to starting CPAP therapy for OSA. Participants will be provided with a GSM (Global System for Mobile communication) modem to allow transmission of their CPAP data. Participants data will be retrieved at 7, 14, 21, 30 and 90 days to test the accuracy of the ARI prediction. At the conclusion of the study the GSM unit is returned, and participants continue with CPAP therapy as instructed by their healthcare provider.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18years of age
* Diagnosed with OSA (AHI \>5 events/hour) and eligible for CPAP (fixed or auto) treatment under local requirements
* Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years

Exclusion Criteria:

* Contraindicated for CPAP therapy
* Medically unstable condition/diagnosis that is not yet under control
* Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)
* PLMA (Periodic Limb Movement Activity) Index greater than 15/hr
* Home titration of longer than 5 days
Retroperitoneoscopic Donor Nephrectomy

to compare the results of right and left-sided retroperitoneoscopic donor nephrectomy (RDN).

This was a retrospective study evaluating demographics, intraoperative and postoperative data of 158 kidney donors who underwent RDN from January 2010 to August 2018. Two groups were created according to the side of the surgery including Right RDN (group 1) and left RDN (group 2). The results of the recipients' were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Adult donors
* Kidney donors undergoing retroperitoneoscopic donor nephrectomy
* Recipients of the kidneys
* Donors with the consent form
* Recipients with consent form

Exclusion Criteria:

* open donor nephrectomies
* donors without the consent form
* Recipients without the consent form
Impact of Sunflower Seed Oil Massage on Neonatal Mortality and Morbidity in Nepal

Each year four million babies die during the neonatal period, with the majority occurring in developing countries. Overall, infections account for one-third of all neonatal deaths, with proportions approaching 50% in settings where neonatal mortality rates are high. Infections are predominately due to sepsis, respiratory infections, tetanus, and diarrhea. The investigators long term goal is to identify simple, affordable, and effective interventions that can be delivered at the community level in low-resource settings to reduce neonatal mortality risk due to these infections. The investigators team has conducted research in this area for the past 10 years, with specific focus on newborn vitamin A dosing and topical chlorhexidine antisepsis interventions. Previous community-based research by the investigators group of investigators and others demonstrated that newborn vitamin A dosing can reduce early infant mortality by approximately 20%, and that topical applications of chlorhexidine to the umbilical cord can prevent omphalitis and reduce neonatal mortality risk by 24%. Evidence is growing that neonatal skin plays an important role in protecting the newborn infant from invasive pathogens. Barrier function of the neonatal skin, however, is incomplete in newborn infants, especially those that are pre-term or of low birth weight. Full-body massage of newborns with mustard oil, practiced almost universally (\~95%) in communities of south Asia, may further compromise skin barrier function through decreased structural integrity leading to increased trans-epidermal water loss and increased risk of percutaneous penetration by invasive pathogens. Loss of structural integrity is not seen after massage of neonatal skin with alternative topical emollients, including sunflower seed oil. Furthermore, sunflower seed oil has been shown to accelerate recovery of the skin barrier function, improve skin condition, and reduce the risk of both nosocomial infections and neonatal mortality among hospitalized newborns in low-resource settings. The specific hypothesis of this study is that substituting mustard oil with sunflower seed oil for topical applications during full body massage of newborns in the community will reduce neonatal mortality and morbidity by improving overall skin barrier function and reducing exposure to invasive pathogens.


Eligibility Criteria:
Inclusion Criteria:

* Baby born alive
* Baby born in study area