cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Loading Dose in Advanced Lung Cancer

Hypovitaminosis D is highly prevalent in people with lung cancer, and may have adverse clinical consequences. The long and variable pharmacokinetic half-life of vitamin D makes prompt vitamin D replacement problematic. This is an open, one-armed therapeutic intervention using a loading dose of vitamin D that will be predicted to increase plasma 25-hydroxyvitamin D concentrations of every patient well into the normal range (\> 100 nmol/L) within 2 or 3 weeks and monitored after 2 and 3 weeks of loading and maintenance dose. Preliminary data will also be obtained to identify potentially clinical important outcome benefits for future investigation. The outcomes are

1. plasma 25OHD concentration
2. Vitamin D binding protein and other plasma concentrations
3. Mood and symptom


Eligibility Criteria:
Inclusion Criteria:

1. Any patient with advanced lung cancer whether or not receiving specific anti-cancer therapy
2. Mentally competent (but need not be fluent in French or English if capable neutral translator available)
3. Self report of reduced food intake and/or involuntary weight loss of any extent at time of enrollment: does not have to be documented

Exclusion Criteria:

1. Current diagnosis of primary hyperparathyroidism
2. Nephrocalcinosis
3. Current or suspected active tuberculosis, histoplasmosis, sarcoidosis, or other granulomatous disease
4. Current using a vitamin D supplement providing \> 1000 IU/day
5. Current prescribed calcitriol in any dose
6. History of extensive sunlight exposure (\> 30 min summer sunlight exposure per day for more than 5 days per week) in previous 3 months
7. Expected to die within next 2 months
8. Pregnancy
A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics

The study is a small pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a randomized controlled clinical trial comparing two mindfulness-based lifestyle modification programs to help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and the other using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA). Intervention content will include information about nutrition (carbohydrate restriction or American Diabetes Association recommended diet) and emotion regulation and mindful eating strategies.

Approximately 40 individuals with Type II diabetes or prediabetes will be randomized in a 1:1 ratio to treatment groups. Groups will meet for 12 weekly sessions, then approximately biweekly for 3 sessions, for a total of 15 1.5-2 hour sessions over 4.5 months. Participants will be evaluated at 0, 1 month, 3 months, and 6 months. Our outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity).

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus, Type 2.
* HgbA1c \> 6.0% at screening. This is to confirm the diabetes diagnosis.
* Aged 18 years old and older
* BMI 25 and above.

Exclusion Criteria:

* Condition that will make it difficult for participation. Such as:

  * cancer
  * liver failure
  * unstable coronary artery disease
  * severe emphysema
  * bulimia or strong history of bulimia
  * vegan
* Laboratory evidence of organ dysfunction

  * Abnormal kidney function (serum creatinine)
  * thyroid stimulating hormone out of normal range
* Previous use or new changes in medications that can interfere with the measures used in the study:

  * current use of insulin and no immediate plans to start or increase diabetic mediations.
  * more than 3 oral hypoglycemic medications.
  * use of systemic (oral or IV) corticosteroids in the 6 months prior
  * severe autoimmune disorders
  * initiation of psychiatric medications in past 2 months.
* Weight loss confounds

  * Current use of weight loss medications or supplements.
  * History of or planned weight loss surgery.
* Other

  * Pregnant or planning to get pregnant in the next year, breastfeeding, less than 6 months post-partum.
  * Unable or unwilling to do home glucose monitoring.
Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying combination chemotherapy and radiation therapy to see how well they work in treating children with localized ependymoma.

OBJECTIVES:

* Determine the event free and overall survival of children with incompletely resected localized ependymoma when treated with adjuvant cyclophosphamide, etoposide, and vincristine followed by radiotherapy.
* Determine the response rate in these patients to this regimen.

OUTLINE: This is a multicenter study.

Patients undergo surgery to remove as much of tumor as possible. Patients with residual disease proceed to chemotherapy, while those with no residual disease proceed directly to radiotherapy.

Chemotherapy begins within 3 weeks of surgery and consists of vincristine IV on days 1, 8, and 15, cyclophosphamide IV over 3 hours on day 1, and etoposide IV over 4 hours on days 1-3. Treatment repeats every 4 weeks for up to 4 courses. Patients who progress after 2 courses proceed to radiotherapy. If residual disease is still present at completion of chemotherapy, second look surgery is recommended.

Patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4 weeks of surgery, within 3 weeks of completion of chemotherapy, or within 4 weeks of second look surgery.

Patients are followed at 6 weeks after radiotherapy, every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 2-3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven nonmetastatic intracranial ependymoma

  * Cellular
  * Papillary
  * Clear cell
  * Mixed cell
  * Anaplastic
* No myxopapillary ependymoma, subependymoma, or ependymoblastoma

PATIENT CHARACTERISTICS:

Age:

* 3 to 20

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* No hematologic disease that would preclude study participation

Hepatic:

* Not specified

Renal:

* No renal disease that would preclude study participation

Other:

* No concurrent unrelated disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Prior steroids allowed

Radiotherapy:

* No prior radiotherapy

Surgery:

* Not specified
Pediatric Head Lice Study Product Comparison

* To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric population.
* To evaluate the safety of LiceMD in a pediatric population.

Head lice, or Pediculus humanus capitis, cause an estimated 6 to 12 million infestations per year in the U.S., most commonly affecting children 3 to 11 years of age. Despite common perceptions, head lice crawl, and cannot hop or fly. For this reason, transmission occurs most often by human head-to-head contact, and much less commonly by the sharing of personal items such as hats, coats, combs, or towels. Because head lice feed on human blood, they cannot live on pets and are only viable 1-2 days on surfaces other than the human head.

Eligibility Criteria:
Inclusion Criteria:

* Subject Inclusion Criteria
* Current lice infestation, confirmed by school nurse. Must have live lice - not just eggs. A minimum of one live louse and 10 viable eggs must be seen or three live lice.
* Male or female child; age 3 - 12
* Willing to participate in study, and parent/guardian sign informed consent
* Parent/guardian must be able to read and follow directions and complete all questionnaires
* For children/parents who agree to the experimental arm of the study, agree not to use any other head lice product or home remedy lice treatment during the study.

Exclusion Criteria:

* No live lice, only eggs.
* Less than three live lice observed with less than ten viable eggs
* No hair on the head
* Buzz cut or crew cut
* Use of other lice treatment or home remedy lice treatment within the past 4 weeks
* Chronic scalp disorder (such as psoriasis) that would limit the school nurse's ability to detect lice and/or identify adverse events
* Currently taking an antibiotic
* Does not follow instructions.
Comparison of the Effectiveness Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells

Comparison of the effectiveness metformin versus placebo for deceasing proliferative marker Ki-67 expression in endometrial tumours when given for 4 weeks before hysterectomy in endometrial cancer cells.

Endometrial cancer is one of the most common gynecological cancers. Preclinical studies in endometrial cancer (EC) show that metformin reduces cellular proliferation by PI3K-AKT-mTOR inhibition. The investigators tested the hypothesis that short-term presurgical metformin reduces cellular proliferation in endometrial cancer. However, no good quality of evidence base supports the effectiveness of metformin for deceasing proliferative marker in endometrial cancer.

Eligibility Criteria:
Inclusion Criteria:

* Women with endometrial cancer who undergoing complete surgical staging and agrees to participate in this study

Exclusion Criteria:

* Women without diabetes type 1 and 2
* Women who have allergy Biguanide
* Women who have hypoglycemic medication
* Women who have GFR \<45 ml/min/1.73 m2
* Women who have evidence of stage 3 or 4 of endometrial cancer
Intracranial Artery Stenosis Magnetic Resonance Imaging: Aetiology and Progression

Stroke has become the leading cause of death in China. It has been shown that intracranial artery stenosis (ICAS) plays a key role in Chinese stroke patients. Although most of stenotic diseases in intracranial arteries are atherosclerotic, a substantial number of other vascular diseases, such as dissection, arteritis, moyamoya disease, and reversible cerebral vasoconstriction syndrome (RCVS), can also lead to intracranial artery luminal narrowing. It is challenging to differentiate the etiologies of ICAS relying on measuring luminal narrowing by angiographical approaches. In addition, the progression of intracranial atherosclerotic disease (ICAD) has been demonstrated to be highly associated with the risk of ischemic cerebrovascular events. However, the influence factors for ICAD progression remains unclear.

High-resolution magnetic resonance imaging (HR-MRI) has been widely used to assess ICAS diseases. The different etiologies of ICAS are differentiable by MR-MRI according to the features of location, shape, signal pattern, remodeling, and contrast enhancement. Investigators have proved that HR-MRI is a reproducible technique that may be reliably utilized to monitor the changes of ICAD during natural follow-up or medical treatment.

The ICASMAP (Intracranial Artery Stenosis MR Imaging: Aetiology and Progression) is a prospective, cross-sectional, observational, and multicenter study. The objectives of ICASMAP are to determine: 1) the spectrum of etiology of ICAS in stroke patients; and 2) the influence factors for progression of ICAD. A total of 300 patients with symptomatic stenotic disease in intracranial arteries (stenosis range: 30%-99%) will be recruited within two weeks after symptom onset from 18 different hospitals across Beijing-Tianjin-Hebei region in China within 1 year. All the patients will undergo HR-MRI for intracranial arteries at baseline, one-year, and two-years. The clinical risk factors will be collected and blood draw will be conducted. The ICASMAP study may help to improve the precise diagnosis and intervention of ICAS and stroke prevention.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recent transient ischemic attack or ischemic stoke within two weeks after symptom onset and intracranial artery stenosis (30%-99%) at least in intracranial internal carotid artery,basilar artery, M1 segment of middle cerebral artery , A1 segment of anterior cerebral artery, or P1 segment of posterior cerebral artery determined by computed tomography angiography or magnetic resonance (MR) angiography.

Exclusion Criteria:

* Patients with specific carotid artery atherosclerotic plaques
* Patients with evidence of may causing cardiac thrombosis disease
* Patients with claustrophobia
* Patients with contraindications to MR imaging
* Patients with heart or respiratory failure
* Patients with renal insufficiency (serum creatinine \>133umol/L)
* Patients with serious disturbance of consciousness
* Patients with brain tumors
* Patients with cerebral hemorrhage
* Pregnant woman or plan to pregnant within recent 2 years
ICP-248 in Combination with Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years.
2. CLL/SLL is diagnosed by histopathology and/or flow cytometry according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2018):
3. Having an indication for treatment that meets the criteria for iwCLL 2018
4. Subjects must have measurable lesion according to the Lugano 2014 Assessment Criteria.
5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.
6. Adequate hematologic function
7. Patients with basically normal coagulation function
8. Patients with adequate hepatic, renal, pulmonary and cardiac functions
9. Subjects are able to communicate with the investigator well and to complete the study as specified in the study.
10. Before the trial, the subjects shall understand the nature, significance, possible benefits, inconveniences and potential risks, as well as the study procedures of the trial in detail and voluntarily sign the written Informed Consent Form (ICF).

Exclusion Criteria:

1. Central nervous system involvement.
2. Concomitant Richter transformation.
3. Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis.
4. Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days.
5. History of allogeneic stem cell transplantation.
6. Major organ surgery (excluding aspiration biopsy) or significant trauma within 28 days prior to the first dose of the investigational drug or require elective surgery during the trial.
7. Presence of active infection that requires intravenous anti-infective therapy.
8. Hepatitis B or C virus infection.
9. History of immunodeficiency disease or Significant cardiovascular disease
10. Central nervous system disorders or Severe bleeding disorder
11. Alcohol or drug dependence.
12. Mental disorders or poor compliance.
Scoring Model for Predicting Outcome in Patients With Cardiogenic Shock

This study aims to develop a predictive model for the outcomes of patients with cardiogenic shock

This retrospective observational study will enroll patients with cardiogenic shock admitted to the cardiac care unit. Patient characteristics, clinical events during hospitalization, and laboratory examination findings will be collected and analyzed to determine factors associated with mortality. A nomogram will be developed accordingly and will undergo both internal and external validation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cardiogenic shock
* Admitted to the cardiac care unit (CCU)

Exclusion Criteria:

* Non-cardiogenic shock in origin
* Post open heart surgery
Evaluation of Diaphragm in Chronic Obstructive Pulmonary Disease Patients by Ultrasound in Relation to Severity

The study of the diaphragm is an important point in the assessment of COPD patients.

Ultrasonographic evaluation of the diaphragm is considered a simple, non-invasive, available bedside technique. Ultrasonography can be used for evaluation of the site, structure, and motion of the diaphragm, assessment of excursion, and thickness.

The aim of the study is ultrasonographic assessment of the diaphragm in COPD patients and its relation to disease severity

The study was conducted on eighty patients, forty COPD patients who were diagnosed and classified into four groups according as following: The first group: included 10 patients with a mild stage. The second group: included 10 patients with a moderate stage. The third group: included 10 patients with a severe stage. The fourth group: included 10 patients with a very severe stage. The study also included forty healthy individuals of the same age and sex as COPD patients. All participants gave their informed consent for inclusion before sharing in the study. Every person was submitted to: Full medical history, Clinical examination,Chest x-ray, spirometry and ultrasonographic assessment of diaphragm function (thickness and excursion)

Eligibility Criteria:
Inclusion Criteria:

* • Stable COPD patients aged more than 40 years who were diagnosed and classified into four groups of severity according to GOLD 2020.

  * Age and sex-matched healthy controls

Exclusion Criteria:

* • Patient with a known neuromuscular disorder.

  * Patient with known anatomical malformation of the diaphragm.
  * Post abdominal or thoracic surgery.
Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla

Examination of major duodenal papilla (MDP) using a standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the modality of choice to examine the MDP. Cap assisted esophagogastroduodenoscopy (CA-EGD) uses a cap fitted to the tip of the scope that can depress the mucosal folds and thus improve visualization and examination of MDP. The aim of this study is to compare CA-EGD to side\*viewing duodenoscope for complete examination of MDP.


Eligibility Criteria:
Inclusion Criteria:

* indication for elective upper endoscopy
* age over 18 years
* ability to provide informed consent

Exclusion Criteria:

* surgically altered upper gastrointestinal tract
* known or suspected upper gastrointestinal strictures
* upper gastrointestinal bleeding
* biliary stent
* planned endoscopic intervention
* American Society of Anesthesiologists class III or higher
* contraindication for or refusal of sedation with Propofol
* inability to give informed consent
Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS.

The clinical study using a sub-therapeutic dose of a GnRH antagonist to reduce overactive LH pulsatility in women with PCOS. With the intervention and lowered LH action we anticipate to decrease androgen levels in women with PCOS. The aim to show for the first time that low-dose GnRH-antagonists can lower LH pulsatility by 20-30% and decrease androgen levels without blunting the hypothalamic-pituitary-gonadal axis and thereby the reproductive functions.


Eligibility Criteria:
Inclusion Criteria:

* Minimum weight of 51 kg
* BMI between 20 and 25
* women with PCOS with AMH\> 28 pmol / L, LH\> 8 IU / mL and testosteronemia \> 0.39 ng/mL
* no hormonal treatment or contraception for 2 months
* women covered by the Social Security system

Exclusion Criteria:

* hormonal treatment or hormonal contraception
* Metformin treatment
* pregnant woman
* inability to understand the newsletter
Testing the Effectiveness of VOICES as Implemented by STD & HIV Prevention Agencies in the US and PR

The purpose of the project is to determine whether the VOICES/VOCES intervention, that was shown to be effective in a research study, is still effective when delivered by STD/HIV prevention agencies.

VOICES/VOCES is a brief, single-session intervention for African-American and Latino adult men and women at high risk for STD/HIV. It encourages condom use and improves condom negotiation skills. A health educator delivers the intervention to groups of 4 to 8 clinic patients in a private room. Groups are made up of people of the same sex and same race or ethnicity. Information on STD/HIV risk behaviors and condom use is delivered by culturally-specific videos, group discussion, and a poster presenting features of various condom brands. Participants role-play condom negotiation modeled in the videos. At the end of the session they are given sample condoms of their choice.

In this project, health educators from the health departments of New York City and San Juan, Puerto Rico conducted the VOICES/VOCES intervention with a sample of patients from one STD clinic in each of their cities. Researchers helped the health departments test whether the intervention is effective when local health educators deliver it.

This project was an RCT with 1699 patients assigned to receive the VOICES/VOCES intervention and 1707 to receive standard of care at each of the two STD clinics (total N=3406). Participant outcomes and their measures are:

1. Change in knowledge and attitudes about condoms as determined by participant profile and survey data
2. Condom acquisition as determined by project coupon redemption data
3. STD incidence as determined by medical chart review and/or surveillance data

In addition, cost accounting data on the amounts and types of resources required to implement the intervention were used to evaluate the intervention's cost-effectiveness. Process evaluation data allow identification of factors that influenced intervention implementation and the effectiveness of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* STD infection at time of recruitment
* Accept treatment for STD infection at time of recruitment

Exclusion Criteria:

* Age under 18 years
Diffuse Optical Tomography (DOT) for Monitoring Response to Neoadjuvant (Preoperative) Chemotherapy in Breast Cancer

The aim of the study is to determine if DOT can detect response early in breast cancer patients undergoing neoadjuvant chemotherapy.

The pilot study will enrol up to ten patients over one year. Patients receiving neoadjuvant chemotherapy for breast cancer will undergo baseline clinical examination, mammography, ultrasound, MRI and DOT before commencement of treatment. DOT will be repeated at 1,3,6 weeks after chemotherapy, and at the end of each chemotherapy regimen. Ultrasound will be repeated every 6 weeks and at the end of treatment. Mammography and MRI will be repeated once at the end of treatment before surgery. A breast pathologist will evaluate the subtype of breast cancer and the pathologic response of the operative specimen at the end of treatment. Patient satisfaction questionnaires will be administered to evaluate their preferences for DOT, ultrasound, mammography and MRI scanning at the beginning and the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving neoadjuvant chemotherapy for breast cancer.
* Patients with locally advanced breast tumours or large operable tumours who require neoadjuvant treatment for downstaging.
* Histological confirmation of invasive breast carcinoma.
* Patients with metastatic disease may be eligible if they have oligometastatic disease and breast surgery after neoadjuvant chemotherapy is planned.
* Signed informed consent
* Age equal to or more than 21 years
* Life expectancy greater than 12 weeks.
* ECOG performance status 0-2

Exclusion Criteria:

* Fungating or ulcerated tumours
* Inability to provide informed consent
* Anticipated inability to follow-up patient for response to chemotherapy
* Any contraindication to undergoing ultrasound, MRI, MMG or DOT