cyrilzakka/clinical-trials huggingface dataset:
Treating Climacteric Symptoms With a Complex Homeopathic Remedy

The purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms.

Complementary treatments for climacteric symptoms are used by many women although their efficacy and safety is mostly unproven.

The use of the complex homeopathic remedy Ovaria comp. for the relief of climacteric symptoms will be examined in this three-armed intervention trial and measured with the menopause rating scale II before and after each study phase of 12 weeks. Participants will receive the verum during two treatment phases of 12 weeks and the placebo during one treatment phase of 12 weeks in different sequences and are stratified for post- and perimenopausal status.

Eligibility Criteria:
Inclusion Criteria:

* Climacteric symptoms\>=3 Points in Menopause Rating Scale (MRS) II
* Communication possible

Exclusion Criteria:

* Hormone replacement therapy within 2 weeks prior to study inclusion
* Other complementary treatments 7 days before and during the study
* Climacteric symptoms caused by operation, chemotherapy or hormonal therapy of cancer
* Allergy to components of the remedy, especially bee poison
Hydroxy Chloroquine and Covid in RA Patients

evaluation of the clinical course of COVID-19 in a cohort of patients with rheumatoid arthritis treated with or without hydroxychloroquine.

Study settings \& sample:

This is an observational, retrospective -case-control, single-center study. This study will include patients who meet the inclusion criteria followed in the Department of Rheumatology and Rehabilitation, Tanta University Hospital, Tanta, Egypt.

Data will be taken from the medical records of patients with rheumatoid arthritis in the outpatient clinic of the Rheumatology and Rehabilitation Department, Tanta University Hospital, Tanta, Egypt. All patients will sign the informed consent form authorizing the collection of these data.

Group classification A) Patients with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.

b) Patients with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen.

Data will be collected and analyzed from patient medical records. It will include the following:

1. Epidemiologic, demographic, and clinical data.
2. Severity of rheumatoid arthritis.
3. Rheumatoid arthritis activity state using the Clinical Disease Activity Index
4. Dose and duration of hydroxychloroquine
5. Need for hospitalization, length of hospital stay, and ICU admission including the need for mechanical ventilation.
6. Duration from the start of symptoms until clinical cure.
7. Severity of COVID-19 disease according to the World Health Organization interim guidance
8. Prognosis.

Laboratory investigations and imaging:

1. Complete blood count.
2. Renal and liver function tests.
3. Random blood sugar.
4. Lactate dehydrogenase, D-dimer.
5. Serum ferritin, C-reactive protein,
6. Chest radiographs or CT scan

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with rheumatoid arthritis superinfected with Covid-19

Exclusion Criteria:

* Insufficient data are available in the medical record.
Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer

This randomized three-arm trial will test the benefit in terms of cancer related fatigue of an activity tracker based exercise training during adjuvant radiotherapy in breast cancer patients.

This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in breast cancer patients on the fatigue syndrome during adjuvant radiotherapy. Quality of Life and the intensity of fatigue will be documented with the fatigue subscale of the FACIT Questionnaire three months after adjuvant radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Capacity for consent
* Minimum age 18
* Presence of breast cancer
* ECOG 0-2
* Indication for adjuvant radiotherapy of breast cancer after breast-conserving surgery or Ablatio mammae

Exclusion Criteria:

* Participation in any other interventional study
* Pregnancy
* Contraindication against physical activity/sport and others
* Severe cardiovascular pre-existing conditions (after myocardial infarction, apoplexy in the last 6 months, congestive heart failure NYHA \> I°)
* preexisting diseases with are relevantly accompanied by a limited mobility in patients (e.g. paraparesis of the lower limbs)
* ECOG Status 3-4
* prior use of activity trackers
Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients with Endometriosis.

Dyspareunia is defined as pain with penetrative sexual intercourse. Women with endometriosis have a nine-fold increased risk of dyspareunia, when compared to the general female population.

A prospective single-blinded randomized controlled trial will be performed evaluating the change in pelvic pain and sexual satisfaction scores from baseline to 6 weeks after treatment with transvaginal photobiomodulation therapy or sham therapy. Treatment will involve 9 planned treatment sessions over 3-4 weeks. 40 women will be included in the study.

Active intervention: Transvaginal photobiomodulation (TV-PBM) Control intervention: Sham transvaginal probe

All subjects will complete 9 treatments over 3-4 weeks and all treatments will be performed with a sheet over the patient's pelvic area to prevent the subject from seeing the probe light, as well as a screen blocking the patient's view of the machine. Subjects randomized to active therapy will undergo TV-PBM treatment during each session per standard TV-PBM treatment protocol. Subjects randomized to sham will undergo blinded sham therapy using an identical probe but without photobiomodulation. Sham therapy will involve the same regimen as the active arm but with the machine turned off. Instead, there will be a recording of the usual noise of the machine to mimic the activation that occurs when stepping on the pedal with the machine on for TV-PBM treatment.

Eligibility Criteria:
Inclusion Criteria:

* Proficient English-speaking females
* Pathology proven endometriosis, \>6 weeks from prior pelvic surgery
* Current dyspareunia

Exclusion Criteria:

* Unable to comply with study protocol
* Pregnant or attempting to become pregnant
* History of or active treatment for pelvic malignancy
* Currently taking light-sensitizing drugs
Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer

The purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV) APR-246 when given to patients with refractory hematologic malignancies or prostate carcinoma.


Eligibility Criteria:
Summary criteria for participant selection:

Inclusion Criteria:

* Male or female ≥ 18 years of age.
* Any below mentioned advanced disease, which is not eligible for other therapies. The diagnosis should have been confirmed either histologically or cytologically:

  1. Acute myeloid leukemia.
  2. Acute lymphoid leukemia.
  3. Chronic lymphocytic leukemia.
  4. Chronic myeloid leukemia.
  5. Chronic myelomonocytic leukemia.
  6. Multiple myeloma.
  7. Non Hodgkin's lymphoma.
  8. Hodgkin's lymphoma.
  9. Myelodysplastic syndrome.
  10. Myelofibrosis.
  11. Hormone refractory, metastatic prostate carcinoma.
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Lung Cancer

platinum-based albumin-bound paclitaxel regimen in advanced non-small cell lung cancer (NSCLC) especially in lung squamous cell carcinoma has a better tumor response rate and safety than solvent-based paclitaxel.However, the safety and efficacy is uncertain in neoadjuvant therapy.

The main purpose of this study is to observe the safety and efficacy of platinum-based albumin-bound paclitaxel regimen in the treatment of non-small cell lung cancer (NSCLC) of stage Ⅱ B and IIIA .

Eligibility Criteria:
Inclusion Criteria:

1.Histological or cytological diagnosis of NSCLC of Stage Ⅱ B and IIIA .

2.18 years or older 3.Performance Status 0 to 2; 4.Appraisable disease; 5.patients can tolerant chemotherapy; 6.Total bilirubin 1.5 x upper limit of normal (ULN); 7.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula).

Exclusion Criteria:

1.Any systemic anticancer treatment for NSCLC；2.Local radiotherapy for NSCLC；3.In this study within five years prior to the start of treatment with other than NSCLC patients with other cancers.4.Any instability in systemic disease; 5.Allergic to paclitaxel or Platinum;6.Pregnant or lactating women;7.Other researchers believe that does not fit into the group
Exercise as Medicine for People With Cancer Sweden

Regular exercise has been shown to have beneficial health effects in cancer survivors, including improving quality of life and other important health outcomes. However, providing people with cancer with easily accessible, high-quality exercise support and programs is a challenge. Therefore, there is a need to develop easily accessible exercise programs that draw upon the current evidence. Supervised, distance-based exercise programs have the benefit of reaching out to many people while providing the support of an exercise professional.

The aim of the EX-MED Cancer Sweden trial is to examine the effectiveness of a supervised, distance-based exercise program, in people previously treated for breast, prostate, or colorectal cancer, on health-related quality of life (HRQoL), as well as other physiological and patient-reported health outcomes. Participants will be randomized to a 3-month supervised, distance-based exercise program or to a usual care control group.

Testing timepoints are baseline, 3 months (end of intervention) and 6 months (3 month followup). At these timepoints, patients will be asked to fill in online questionaires, and and undergo physical tests. A selection of the particpants and personal trainers involved in the intervention will also be invited to participate in focus group discussion or interviews about the experiences of being involved in the EX-MED Cancer Sweden program.

The primary aim of the study is to examine the effectiveness of EX-MED Cancer Sweden on health-related quality of life in people diagnosed with breast, prostate, and colorectal cancer.

The secondary aims are to examine the effect of the program on other important endpoints such as physical activity level, physical function, muscle strength, exercise capacity, symptoms, and body composition (lean and fat mass).

To determine the sustainability of the effects of the supervised program, the study includes a 3-month follow-up time point (6 months post-baseline)

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* males or females
* people diagnosed with any type of stage I-IIIa breast, prostate or colorectal cancer who have undergone and completed curative treatment (note: participants are eligible if they are currently receiving/scheduled to receive anti-hormonal therapy) at the Karolinska Comprehensive Cancer Centre, Sweden

Exclusion Criteria:

* currently receiving or scheduled to receive cancer treatment (except anti-hormonal therapy)
* any medical conditions that may prevent safe participation in the testing or exercise demands of the study
* performing regular exercise throughout the last month defined as undertaking at least 150 mins moderate intensity aerobic exercise and two or more structured resistance exercise sessions per week
* unable to read and speak Swedish.
S100A8 in Serum and Urine as a New Biomarker in Lupus Nephritis

This study aims to evaluate both serum and urine S100A8 as potential biomarkers for Lupus nephritis (LN)

Systemic lupus erythematosus (SLE) is a systemic autoimmune/ inflammatory disease that can affect any organ of the human body. The molecular pathophysiology of SLE remains largely unknown, but complex interactions of genetic factors, the environment, and hormones contribute to disease expression.

Clinical importance of S100 calcium-binding protein A8 protein (S100A8) as a biomarker in SLE has been well-established. During an inflammatory reaction, neutrophils produce S100A8, a Ca2+-binding protein that is part of the S100 family and is found in neutrophil extracellular traps.

In addition to its primary role as a member of the S100A8/A9 heterodimer, S100A8 accumulates in various bodily compartments and functions as a damage-associated molecular pattern molecule upon release. It is a crucial regulator of inflammation and enhances the function of innate immune cells by interacting with members of the immunoglobulin superfamily of cell surface molecules, such as toll-like receptor 4 and the receptor of advanced glycation end products.

Serum S100A8 levels are linked with disease activity, glomerulonephritis, and anti-double-stranded DNA (dsDNA) antibodies (Ab), according to increasing experimental and clinical data. healthy controls (HCs) had lower serum S100A8 levels. Considering that elevated blood S100A8 levels are also seen in several inflammatory disorders such as inflammatory bowel disease and rheumatoid arthritis, it is unclear if this elevated level is adequate to serve as a biomarker specific to SLE.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* Patients with Systemic lupus erythematosus (SLE)
* Patients with SLE and renal affection. SLE diagnosis is based on the 1997 American College of Rheumatology (ACR) criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.

Renal involvement (lupus Nephritis) (LN) can be diagnosed by presence of proteinurea or elevated kidney function and can be confirmed by biopsy if present.

Exclusion Criteria:

* Autoimmune diseases.
* Sjogren's syndrome.
* Rheumatoid arthritis.
* Systemic sclerosis.
* Taking other biologic disease-modifying anti-rheumatic drugs.
* Immunosuppressive drugs.
* Corticosteroid.
A Study of ION537 in Patients With Molecularly Selected Advanced Solid Tumors

The purpose of this study is to evaluate the safety and establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ION537 when administered by intravenous infusion in patients with advanced solid tumors.

This is a single center, open label, non-randomized, Phase 1, two-part study of ION537 in up to 102 participants. Part 1 of the study consists of sequential cohort, dose escalation in patients with advanced solid tumors. Part 2 is dose expansion in patients with molecularly selected advanced solid tumors. In total, the study includes up to 102 participants. The study will consist of a 30-day screening period, a treatment period consisting of sequential consecutive treatment cycles (each cycle will be of 28 days) and a post-treatment follow-up period of at least 28 days following the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years old
2. Participants must have histological diagnosis of local advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent
3. Participants must be in need of systemic treatment for their cancer and either are refractory to or have failed treatment with, are intolerant to or have refused, or are not otherwise a candidate, in the opinion of the Investigator, for any of the currently available established therapies
4. Participants must have available a fresh or recent tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy;
5. Participants must have measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1; or participants may have bone metastatic disease evaluable by Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration-resistant prostate cancer (mCRPC), or according to the tumor evaluation criteria best suited and accepted for the tumor type being evaluated
6. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
7. Participants must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures

Exclusion Criteria:

1. Known history or positive test for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or chronic hepatitis B virus (HBV) infection.
2. Active infection requiring intravenous (IV) antibiotics
3. History of cerebrovascular accident (CVA), myocardial infarction or unstable angina within the previous 6 months before starting therapy.
4. Participants with uncontrolled Type I or II diabetes mellitus (DM); uncontrolled DM
5. Participants with prior anti-cancer therapy within 2 weeks prior to study enrollment or prior radiation therapy within 2 weeks prior to study enrollment.
The Diagnostic and Prognostic Utility of Procalcitonin (ProCT) for Ventilator-associated Pneumonia (VAP)

Our aim in this study is to investigate the potential role of serum ProCT as an early diagnostic marker and later prognostic indicator for VAP.

Ventilator-associated pneumonia (VAP), a bacterial infection that develops after 48 hours or more of intubation, is associated with high morbidity and mortality. Rapid identification of VAP is required to improve survival and to reduce avoidable treatment-associated side effects. Procalcitonin (ProCT), a blood test, is a reasonably specific marker of bacterial infection and its level increases early in sepsis. In this study, a ProCT serum level will be measured in 50 patients with clinically suspected VAP. We aim to show that the ProCT level will be high early in VAP and will stay high in patients with poor prognosis. This will help to address the potential role of ProCT as part of early diagnosis and management of VAP.

Eligibility Criteria:
Inclusion Criteria:

In the preceding 24 h, the appearance of a new opacity or opacities on chest X-ray when compared to previous, and two of the following:

1. white blood cell count \> 12 or \< 5 x 10\^9 cells/L,
2. temperature \> 38°C or \< 35°C, or
3. purulent secretions.endotracheal samples must be collected by bronchoscope/bronchoalveolar lavage with quantitative culture or endotracheal aspiration with quantitative culture (when available) or qualitative culture from each patient to be enrolled in the study. This is a routine procedure done in every case of suspected VAP and is considered to be the standard of care.

Exclusion Criteria:

1. Known underlying chronic inflammatory condition of the lung (e.g., sarcoidosis, vasculitis)
2. Thyroid cancer patients
3. neutropenia (neutrophils \< 0.5 x 10\^9 cells/L
4. Concomitant AIDS
5. Solid organ transplantation with severe immunosuppression
6. New Antibiotic use for more than 18 hrs before blood sample collection
7. Severe pancreatitis
8. Attending physician does not agree with enrollment into the study.
The Effects of Nicotinamide Adenine Dinucleotide (NAD) on Brain Function and Cognition

The purpose of this study is to determine the effects of Niagen (nicotinamide riboside, vitamin B3), on NAD levels, brain function including cognition and blood flow in people diagnosed with mild cognitive impairment (MCI).

Niagen is a patented formula which is the first and only commercially available form of Nicotinamide Riboside (NR). It has been proven in basic science studies as a highly effective NAD booster, but it also works as a vitamin B3 supplement. NAD helps pass energy from glucose to other pathways in the cell. Niagen (Nicotinamide Riboside, vitamin B3) is one of the most effective NAD+ precursors to support cellular health.

The purpose of this study is to determine the effects of Niagen (nicotinamide riboside, vitamin B3), on NAD levels, brain function including cognition and blood flow in people diagnosed with mild cognitive impairment (MCI).

Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed with MCI based on inclusion criteria of Texas Alzheimer's Research Care and Consortium (TARCC) study (IRB: HSC20090535H). We are enrolling both genders, all races and ethnic groups.
* Two week washout period for participants who were taking opioids or a dose of niacin over 200mg

Exclusion Criteria:

* Previously considered as healthy individuals without a MCI or Alzheimer's disease diagnosis based on exclusion criteria of the TARCC study (IRB: HSC20090535H).
* Neurological, psychiatric or active systemic medical disease
* Diabetes
* Moderate or severe depression and/or anxiety as determined the Geriatric Depression Scale (GDS) and the Geriatric Anxiety Scale (GAS), respectively
* Diagnosis of dementia
* Hearing, vision, motor or language deficits
* Alcohol or drug abuse
* Implantation of metal devices
* Administration of Alzheimer's drugs, anticholinergics, neuroleptics, anticonvulsants, opiates, systemic steroids, and mood-stabilizers.
* No opioid use while participating in study
Co-culture and Advanced Maternal Age in PGS Program

Fertilization and embryo development in vivo occurs in appropriate conditions in the mammalian reproductive tract. However in assisted reproductive technology (ART) embryos and oocytes are exposed to certain factors such as temperature, O2 pressure and pH fluctuations that may affect embryo development and viability in vitro. In Preimplantation Genetic Screening program (PGS) the investigators need to culture the embryos until day 5 so the requirement of culture techniques must be optimal to produce acceptable blastocyst rates. As it has been shown before, embryo culture conditions have the potential to impact biopsied embryos and hence PGS success rates.

Nowadays the coculture system with endometrial cells could be an alternative option to improve the blastocyst rates since some publications have indicated that endometrial cells may provide trace elements and growth factors that are not present in defined culture media and reproduce physiologic conditions. Although the role of coculture in vitro fertilization (IVF) has been controversial, a recent meta-analysis has established the potential benefits of coculture system.

The aim of this study was to compare embryologic and clinical outcomes in terms of blastocyst, implantation and pregnancy rates to evaluate endometrial epithelial cell (EEC) coculture versus sequential culture system in advanced maternal age ( ≥39 years) in the PGS program.


Eligibility Criteria:
Inclusion Criteria:

* Advanced maternal age (\>39) undergoing PGS cycle

Exclusion Criteria:

* Other PGS indication
* Altered karyotype
A Study of Delavirdine Mesylate in Combination With Other Anti-HIV Drugs in HIV-Infected Children and Babies

The purpose of this study is to see if it is safe and effective to give delavirdine mesylate (Rescriptor) plus two nucleoside reverse transcriptase inhibitors (NRTIs) to HIV-infected children and babies. This study also examines how the body processes Rescriptor when taken with 2 NRTIs.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* Plasma HIV-1 levels greater than 10,000 copies/ml.