cyrilzakka/clinical-trials huggingface dataset:
The Prognostic Value of CPCs Quantified by Flow Cytometry in Patients With Multiple Myeloma: a Prospective, Multicenter Clinical Trial

This study aims to investigate the prognostic value of circulating plasma cells (CPCs) in patients with multiple myeloma and explore whether CPCs detection might be used in place of bone marrow aspiration for disease monitoring.

Circulating plasma cells (CPCs) represents a phenotypic subset of bone marrow multiple myeloma (MM) cells, which would contribute to the progression and dissemination of the tumor. High-sensitivity techniques such as multiparameter flow cytometry provide a tool for better detection of CPCs; however, a clear threshold has not been identified. The primary objective of the current study is to identify an optimal threshold for CPCs quantified by 8-color flow cytometry (with antibodies to CD38, CD138, CD45, CD56, CD19, CD117 and cytoplasmic kappa and lambda immunoglobulin light chains) and determine the specific relationship between CPCs level and the prognosis of MM. In addition, the evaluation of CPCs at multiple time points will be performed to explore whether CPCs detection might be used in place of bone marrow aspiration for disease monitoring.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria.

* Newly diagnosed multiple myeloma patients.
* Patients without any previous anti-myeloma treatment.
* Age: 18-80years old (adult).
* No history of cancer.
* Informed consent.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria will not be included in the study.

* Received therapy for multiple myeloma.
* Patients diagnosed with monoclonal gammopathy of undetermined significance, smoldering myeloma, nonsecretory myeloma, plasma cell leukemia, amyloidosis, waldenstrom macroglobulinemia or POEMS.
* Imminent or emerging infection.
* Known to be seropositive for a history of HIV.
* A participant is a woman who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this trial.
* Known or suspected of not being able to comply with the study protocol.
Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome

The aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS, focusing specifically on rates of ovulation and pregnancy.

The study will be a randomized controlled clinical trial. Once the eligibility from screening visit is determined prior to baseline visit, randomization will be made by computer randomization for women who are admitted to Beni-Suef University Hospital.

* Before initiation of the study, the population will be divided randomly into 4 equal groups: group A, B, C and D. The adjuvant therapy of each group will be group (A) Metformin 1000mg, group (B) Dapagliflozin 10mg, Group(C) Combined Dapagliflozin-Metformin 10/1000mg and group (D) with no adjuvant therapy (control group).
* The adjuvant therapy will be taken once daily with a main meal and started one month before initiation of letrozole. All groups will take letrozole 2.5mg twice daily from the third day of the cycle for 5 days.

This treatment regimen will continue for three cycles unless positive pregnancy is achieved. No diet restriction will be recommended during the study or change in the lifestyle. The population will be asked to inform about any side effects that may happen during the study. A written informed consent will be obtained from each woman participating in the study.

Eligibility Criteria:
Inclusion Criteria:

* PCOS will based on European Society of Human Reproduction and Embryology/American Society for Reproductive Medicine (ESHRE/ASRM) criteria, the diagnosis is made when at least two of the following criteria are met:

  * oilgo and/or anovulation (infrequent or no ovulation),
  * clinical and/or biochemical signs of hyperandrogenism including hirsutism, acne and/or increased testosterone levels
  * polycystic ovaries on ultrasound (defined as those containing at least 12 follicles measuring 2-9 mm in diameter arranged peripherally around an echo-dense stroma and/or with increased ovarian volume of at least 10 ml).

Exclusion Criteria:

* Other causes of hyperandrogenism mimic PCOS such as congenital adrenal hyperplasia, Cushing's syndrome, or androgen secreting tumors are excluded.
* Persistent hyperprolactinemia,
* thyroid dysfunction defined as TSH \< 0.2 mIU/ML or \>5.5 mIU/mL)
* patients with menopausal levels of FSH (\> 15 mIU/mL) (A normal level within the last year is adequate for enter the study).
* Liver disease is defined as AST or ALT \> 2 times normal or total bilirubin \>2.5 mg/dL, #kidney disease defined as BUN \> 30 mg/dL or serum creatinine\> 1.4 mg/dL or significant
The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation

Fifty patients will get probiotics (109 bacteria \[L. acidophilus, B. bifidum, S. thermophilus, L. rhamnosus, L. casei\] in 2 capsules) and half will get placebo (2 capsules that look the same like the probiotic capsules and will contain microcrystalline cellulose, artificial brown color, magnesium strearate, and silica dioxide). The patients and the staff will be blinded to the identity of the study medications.

Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.

Each individual will be studied for changes in biochemical inflammatory and immunological markers and changes in flow medicated diameter that will be measured by the brachial artery method (that is evaluating endothelial function). Every patient will be evaluated for his/her ability to produce endothelial progenitor stem cells (EPCs).


Eligibility Criteria:
Inclusion Criteria:

* patients with ulcerative colitis and crohns' disease

Exclusion Criteria:.

* notable caveats are that arteries smaller than 2.5 mm
Role of Drain in Decreasing Postoperative Complications

postoperative complications are common after cesarean section

wound infection can occur after cesarean section

Eligibility Criteria:
Inclusion Criteria:

Women undergoing cesarean section

Exclusion Criteria:

* Women who deliver by normal vaginal delivery
An Integrated Intervention of Computerized Cognitive Training and Physical Exercise in Virtual Reality for People With Alzheimer's Disease (JDome)

JDOME is a randomized controlled trial to test the effectiveness of a computerized cognitive training with the Brainer web platform and aerobic training with the JDOME system vs. a computerized cognitive training with the Brainer web platform and aerobic training with a standard exercise bike in subjects with Alzheimer's Disease at early stage. The JDome BikeAround is a tool that take people with dementia on a virtual bicycle tour along the paths of memories. It combines an exercise bike, a dome-shaped projector and Google Street View technology.

JDOME study is designed as a randomized controlled trial to test the effectiveness of a training that combines the JDome virtual reality system for aerobic exercise with computerized cognitive training via tablet. The Experimental Group (EG) will receive computerized cognitive training with the Brainer web platform and aerobic training with the JDOME system (a tool that combines an exercise bike, a dome-shaped projector and Google Street View technology).The Control Group (CG) will receive computerized cognitive training with the Brainer web platform and aerobic training with a standard exercise bike.

Assessment will be performed at the baseline (T0), at the end of intervention (after eight weeks -T1) and 12 weeks after the end of intervention (follow-up T2).

The primary aim is to assess the stabilization of the global cognition of people with mild-stage Alzheimer's disease at the Mini-Mental State Examination (MMSE) and at the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog); The secondary aim is the analyses of the modification of the quality of life, mood, behavioral disturbances, and physical function in people with mild-stage Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 and over;
* Pre-existing diagnosis of Alzheimer's, in mild phase, according to the 2011 criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA);
* Clinical Dementia Rating Scale CDR = 1;
* Mini Mental State Examination MMSE \> 19;
* Functional Ambulation Categories FAC ≥4;
* Tinetti scale ≥ 20;
* Presence of a contact family caregiver
* Reside at home

Exclusion Criteria:

* Failure to meet the inclusion criteria
* Sensory deficits not compensated by the use of prostheses
* Psychological and behavioral disorders not compensated by drug treatment
* Medical contraindication to moderate intensity aerobic exercise
Virus as Treatment of C. Difficile Infection (VISION)

Fecal Virome Transplantation (FVT) has in small studies shown benefit in the treatment of recurrent C. difficile infection.

In the VISION study we will treat patients with recurrent C. difficile infection with FVT capsules and compare the treatment with Fecal Microbiota Transplantation (FMT) capsules. Both will be following af standard treatment of antibiotics (Vancomycin)

In the VISION study we will treat patients with recurrent C. difficile infection (CDI) with FVT capsules and compare the treatment with Fecal Microbiota Transplantation (FMT) capsules. Patients will be randomised to receive either FMT or FTV capsules.

Patients will be followed for one year to investigate the risk of a new recurrence of CDI.

Patients and researchers involved in the treatment of the patients will be blinded to the treatment

Eligibility Criteria:
Inclusion Criteria:

* Recurrent C. difficile infection (first or second recurrence)
* Understand danish

Exclusion Criteria:

* Serious food allergy (anaphylaxis)
* Other pathogenic bacteria/virus in stool sample prior to inclusion
* Inability to ingest capsules
* Gastrointestinal perforation in the 180 days prior to inclusion
* Previous treatment with FMT og rectal bacteriotherapy in the 180 days prior to inclusion
* Short bowel syndrome
* Pregnancy or planning of pregnancy
* Participation in other clinical trial in the 30 days prior to inclusion
* Stoma
* Other condition where FMT is considered contraindicated
Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block

Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results.

The present randomized study aims to compare the postoperative analgesic effects of dexamethasone and dexmedetomidine as adjuncts to serratus anterior plane block in women undergoing modified radical mastectomy.

Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results.

Serratus anterior plane block (SAPB) with ultrasound guidance is a fascial plane block that proved to be feasible, safe and effective tool for reduction of postoperative pain after thoracic and breast surgeries. In multiple instances, SAPB is used with additional adjuncts e.g. dexamethasone or dexmedetomidine to improve analgesic potency and duration.

Eligibility Criteria:
Inclusion Criteria:

Consecutive American Society of Anesthesiologists (ASA) class I-II female patients with breast cancer indicated for modified radical mastectomy

Exclusion Criteria:

Allergy to the study medications . Patients will also be excluded if they have history of chronic pain conditions, opioid dependence or if they received prolonged analgesic therapy prior to surgery.
Comparison of IPACK and Adductor Canal Block Combination Versus Epidural Analgesia for Total Knee Arthroplasty

To compare the efficacy and complications of IPACK and adductor canal block combination and epidural block in patients who will be operated for knee arthroscopy under spinal anesthesia.

Between 15.08.2022 and 15.04.2023, the patients who will be operated on for knee surgery under spinal anesthesia, older than 18 years of age were included in the study. Demographic characteristics of the patients, comorbidities, ASA scores, mobilization time, amount of postoperative analgesic use, and postoperative pain scores of the 1. 8. 24. hours will be observed. The vas score at the 3rd month was learned over the phone.

Eligibility Criteria:
Inclusion Criteria:

* Those who consented to participate in the study
* Patients over the age of 18 who will be operated on due to knee pathology
* Patients to be operated under spinal anesthesia
* Disease that will limit cooperation

Exclusion Criteria:

* Patients under the age of 18
* Patients to be operated under general anesthesia
* Disease that will cause limited cooperation
Head and Neck Cancer Registry (LORHAN)

The primary objective of this study is to describe, in detail, patterns of care for head and neck carcinoma patient


Eligibility Criteria:
Inclusion Criteria:

* Pathologically (histologically or cytologically) confirmed new diagnosis of carcinoma involving the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or neck node metastasis from unknown origin
* Scheduled to receive radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy
* Written informed consent

Exclusion Criteria:

* Registry participation does not exclude participation in clinical trials.
* Patients scheduled to receive or who have received surgery are eligible for Registry participation as long as they are also scheduled to receive medical therapy.
A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin

This trial was conducted in the United States of America (USA). The aim of this clinical trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian subjects, and to identify somatostatin-related adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent before any trial related activities
* Japanese and Caucasian males respectively
* Healthy subjects based upon medical history, physical examination, vital signs, ECG, serum biochemistry and haematology and urinalysis
* Body Mass Index (BMI) between 17 and 30 m2/kg, inclusive
Development of Protocols and Methods for Image Processing and Enhancement of MRI Data

The purpose of the study is to develop new Magnetic Resonance Imaging (MRI) protocols and methods for image processing and enhancement. Different setting of acquisition parameters used in conventional clinical MRI protocols will be defined, to create "New Protocols". Then post-processing will be applied on new protocols to enhance the image quality. Finally a comparison of image quality will be performed to compare the image quality of images obtained by conventional protocols with those obtained with the New Protocols.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers for clinical MRI examination
* Patients undergoing clinical MRI examination
* Capable to provide an informed written consent form

Exclusion Criteria:

* Any contraindication to MRI scanning, such as pacemakers or heart rhythm disturbances, permanent cosmetics or certain metallic implants in the body (excluding dental implants).
* Age \<18 years old
* Pregnancy
* Claustrophobia
Decreasing Postoperative Complications by Goal-Directed Fluid Therapy During Esophageal Resection

Surgery for cancer of the esophagus is associated with a high risk of postoperative complications. It has been shown that the risk of postoperative complications can be decreased by optimising the amount and type of infusion fluids given during surgery, steered by measurement of cardiac stroke volume, mostly done with a device called esophageal Doppler. This device can however not be used during this type of surgery. This study wants to test the hypothesis that postoperative complications in patients operated for esophageal cancer can be partially prevented by using a goal directed strategy for the administration of fluids and drugs influencing the heart and vessels, based on measurement of stroke volume by pulse wave analysis (FloTrac).


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for transthoracic esophageal resection because of malignancy, without colonic interposition who leave informed consent

Exclusion Criteria:

* ASA 4 or 5
* Atrial Fibrillation
* Significant Aortic or Mitral Valve Insufficiency
* Preoperative planned extensive monitoring beyond CVP, arterial blood pressure, diuresis, ECG and other standard monitors
A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]

Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC.

Part A of this study will determine the Maximum Tolerated Dose of Debio 0932 in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients with Stage IIIb or IV NSCLC, and with docetaxel in previously treated patients with Stage IIIb or IV NSCLC.

Escalating doses of Debio 0932 will be given to subsequent patients in combination with standard doses of these 3 background chemotherapies.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known epidermal growth factor receptor (EGFR) mutation
* Advanced or metastatic disease (Stage IIIb or IV)
* Patients to be treated with cisplatin/gemcitabine or cisplatin/pemetrexed: No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if \> 6 months ago); Patients to be treated with docetaxel: ≥ 1 previous treatment with chemotherapy
* Measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* ECOG performance score 0-1
* Life expectancy ≥ 3 months
* Adequate bone marrow-, renal- and hepatic function
* LVEF ≥ 55% on cardiac ultrasound

Exclusion Criteria:

* Symptomatic brain metastases
* Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn's disease)
* Concurrent treatment with any other systemic anti-cancer therapy
* Serious concomitant uncontrolled medical conditions
Balance After Knee Arthroplasty

Evaluation of patients before and after knee arthroplasty regarding balance, function and quality of life. Comparison of total and unicompartmental knee arthroplasty. Comparison of the primary outcome parameter and selected secondary outcome parameters to healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Primary gonarthrosis
* planned TKA or UKA
* adequate cognitive and lingual competence
* informed consent

Exclusion Criteria:

* TKA or UKA revision
* Surgery after trauma
* Rheumatic disease
* Neurologic disease
* previous arthroplasty of the lower extremity (\<9 months)
* cardiovascular disease
* restricted weight bearing of the lower extremity after surgery
Effect of Repositioning Frequency Neonates Receiving Phototherapy

Purpose: The present study was conducted to determine the effect of repositioning frequency during phototherapy on bilirubin level and neonates comfort.

Design and methods: This was a single-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trial conducted in a neonatal intensive care unit. Participants were randomly assigned to one of three groups: Supine position group (n = 20), hourly position change group (n = 20), and control group (n = 20). The bilirubin level and comfort levels of the neonates were evaluated.

Purpose: The present study was conducted to determine the effect of repositioning frequency during phototherapy on bilirubin level and neonates comfort.

Eligibility Criteria:
Inclusion Criteria:

* gestational age between 35-42 weeks
* birth weight of 2000 g or more
* indication for phototherapy
* no previous phototherapy,
* no medical diagnosis other than prenatal hyperbilirubinemia
* stable health status
* no clinical signs of dehydration
* transition to oral feeding, no sucking problems
* being at least 2 days old on the day of phototherapy

Exclusion Criteria:

* a sudden change in stability during phototherapy and
* phototherapy duration of less than 24 hours
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Male Subjects

The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in male patients.


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign informed consent before screening examinations are performed and before the study drug is administered
* Males \> 18 years of age
* Subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration \> 3 hours and \< 45 days) at the time of randomization
* Subjects who are in no distress and hemodynamically stable (supine systolic blood pressure \> 90 mmHg and diastolic blood pressure \< 105 mmHg)

Exclusion Criteria:

* Acute myocardial infarction and cerebrovascular accidents
* Coronary and heart failure symptoms
* Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities
* Electrolyte abnormalities
* Concurrent antiarrhythmic treatments