cyrilzakka/clinical-trials huggingface dataset:
mtDNA and Embryo Metabolism

The present study has the objective to study whether the mitochondrial DNA copy number values that can be generated when human embryos are analyzed for chromosomal content before embryo transfer correlates with the actual number of mitochondria as well as their energy requirements of the human embryo.

The possibility of analyzing trophectoderm cells from human blastocyst during preimplantational genetic testing offers the opportunity of analyzing not only the chromosomal constitution of the trophoblastic cells, and by extension, to infer not with certain degree of uncertainty, the chromosomal content in the inner cell cells mass and the entire embryo; but analyzing other interesting aspects related to cellular physiology such us the mtDNA content.

The number of mitochondrial copy number has a huge variation among oocytes from the same cohort and also from oocytes from different patients. It is believed that this initial number of mtDNA content is correlated with the ability of oocytes to fertilized and to achieve blastocyst stage. Whatever the initial concentration of mtDNA a given oocyte will have, it expected to equally segregate into the number of blastomeres along embryo development, so the mtDNA copy number of per daughter cell will transiently decrease, being the smallest at the blastocyst stage. Studies in different mammalian species including humans have shown that mtDNA replication does not occur before morula stage so the mitochondrial content of the oocytes should be enough to sustain embryo development before implantation occurs.

The net amount of mitochondrial DNA will exponentially increase at blastocyst stage coinciding with an increases in oxygen consumption. Despite the mtDNA copy number is higher in ICM compared to TE cells the proportion of moderate and high activity mitochondria is higher in the TE cells. This also agrees with mitochondrial morphological changes in the trophectoderm cells where mitochondria are much more elongated, less matrix electrodense and have more cristae, in ICM the will be rounded and more electrodense.

The objective of the present work is to analyze whether a correlation exist between the mitochondrial DNA copy number and both the actual number of mitochondria in the blastocyst and the metabolic needs of the human blastocysts and the ATP production.

Eligibility Criteria:
Inclusion Criteria of women whose blastocysts will undergo PGT-A and be eligible for study:

* \> 38 years old
* Sperm count: \> 2 million spermatozoids/ml
* Oocytes retrieved \> 4 oocytes MII
* Antral Follicles (AFC: ≥4)
Dietary Pork, Appetite and Weight Loss in Human

The entire study protocol will last 13 weeks. Women will be randomly assigned to one of two experimental groups: high and low protein. All women will consume their unrestricted habitual diet during week 1 while baseline testing and measurements are taken. Starting at week 2, women in both groups will be counseled to consume a 750 kcal/day energy deficit diet containing either the RDA (LP group) or more than the recommended dietary allowance (RDA) (HP group) for protein. The energy restriction period will continue for 12 weeks (through study week 13) and is expected to result in body weight reduction of approximately 17 pounds. Testing and measurements will be repeated during week 13.


Eligibility Criteria:
Inclusion Criteria:

* Eligible women will have a body mass index (BMI: weight (kg)/height (m2)) ranging from 26-36.
* Must be at least 21 years old.

Exclusion Criteria:

* Women with medical conditions that might place them at risk for participating in the study or interfere with the successful completion of the study protocol will be excluded.
* BMI \<26 or \>36.
* Younger than 21 years old.
Masitinib in Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not FGFR3

This phase 2 study was designed to assess the safety and efficacy of masitinib (AB1010) in patients with relapsing/refractory t(4;14) Multiple Myeloma. Response and progression were assessed according to the Bladé revised IMWG criteria1 from lowest point.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed multiple myeloma with a t (4; 14) translocation by FISH and PCR, expressing or not expressing FGFR3 identified by FACS
* Patients with Multiple Myeloma progressing or relapsing after at least two prior therapies (including conventional chemotherapy and/or high dose therapy) or who get a reduction of M-protein less than 75% within 3 months after a high dose treatment (Melphalan 200mg/m2) or after the plateau obtained for 3 months duration following to a conventional chemotherapy
* Patient with rapidly progressive disease with cytopenia and / or renal failure have to be stabilized with chemotherapy (if possible 3 cycles of VTD ( Bortezomib/Thalidomide/dexamethasone) or high dose Melphalan regimen followed by a 4 weeks washout period before the inclusion in the study.
* Patients must have a clearly detectable and quantifiable monoclonal M- component value (\>5 g/l) in the serum and / or urine light chain excretion (\>0,5 g/d)

Exclusion Criteria:

* Prior corticosteroids within two weeks before enrolment
* Prior local irradiation within two weeks before enrolment
* Prior experimental or standard treatment (other than steroids and local irradiation) within 30 days before enrolment
External Fixator or Antibiotic-coated Plate in Severe Open Long Bone Fractures

The purpose of the study is to assess whether infection rate is reduced with use of antibiotic-coated plate in severe open tibial fractures compare to use of external fixators


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18yrs,
* Gustilo-Anderson IIIA and IIIB open fractures,
* involvement of any long bone fractures that can be fixed with either plate or uniplanar external fixation,
* wound can be closed primarily, with skin graft or flap, or can heal secondarily

Exclusion Criteria:

* Patients with traumatic brain injury,
* spinal cord injury,
* severe burns,

  * 1 long bone fractures,
* refusal to consent,
* history of allergies to ceftriaxone or sulbactam,
* fractures associated with vascular injury
* and non-compliance with follow-up.
Infrared Thermography in Finding Skin Lesions in Patients With Kaposi's Sarcoma

RATIONALE: Diagnostic procedures, such as infrared thermography, may help find Kaposi's sarcoma and learn the extent of disease.

PURPOSE: This clinical trial is studying how well infrared thermography finds skin lesions in patients with Kaposi's sarcoma.

OBJECTIVES:

Primary

* Compare ultra-sensitive infrared thermographic images with visible light digital photographic images and clinical dermatologic examination as methods of measuring cutaneous lesions in patients with Kaposi's sarcoma (KS).

Secondary

* Compare differences in modulation of temperature detected in KS skin lesions with non-involved skin of the same patient and with normal skin of healthy volunteers by sequential imaging using the infrared thermographic camera.

OUTLINE: This is a controlled, pilot study.

Patients undergo clinical assessment followed by simultaneous digital photographic camera imaging and high-resolution infrared thermographic camera imaging of designated normal skin areas and selected marker lesions. Before imaging, a metal bar chilled to 0º C, 10º C, and 25º C is applied to the lesions and designated normal skin areas for up to 90 seconds.

Healthy volunteers (controls) undergo the same procedure as for the patient except only designated normal skin areas are used.

PROJECTED ACCRUAL: A total of 20 patients and 10 healthy volunteers (controls) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Histologically confirmed cutaneous Kaposi's sarcoma (KS)

    * At least one skin lesion accessible for imaging
    * HIV positivity with proven cutaneous KS and concurrent visceral or mucous membrane involvement allowed
  * Healthy volunteer (regardless of HIV status) (control)

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Pregnancy allowed

PRIOR CONCURRENT THERAPY:

* Prior topical, intralesional, or systemic treatment allowed
Tranexamic Acid Reduce Blood Loss in Meningioma Resection

In neurosurgical setting, a large sample size trials of tranexamic acid (TXA) has been limited to TBI and SAH.

The evidence of TXA in brain tumor was scarce. A few case reports support the role of TXA in brain tumor patients with significant intraoperative bleeding and difficult achieving hemostasis. To prove the benefit of TXA for an attenuation of blood loss in brain tumor patients, research with a larger sample size is required. This prospective, randomized double-blind controlled study will be conducted to evaluate the effect of TXA in reducing blood loss and blood transfusion in patients with intracranial meningiomas, diameter \> 5 cm in at least 2 dimensions from the latest radiographic findings.

Background and Literature review:

1. Meningioma
2. Coagulation in craniotomy to remove meningioma
3. Bleeding in craniotomy to remove meningioma
4. Tranexamic acid (TXA)
5. Knowledge gap The topics shown above has been reviewed to conduct a prospective randomized double-blind, placebo controlled study.

To prove the study hypothesis: Will intraoperative TXA administration in adult patients scheduled for craniotomy to remove large meningioma decrease blood loss?

Eligibility Criteria:
Inclusion Criteria:

* The patients whose aged 18 to 60 years
* The patients who was diagnosed intracranial meningioma
* The radio-graphic finding of tumor diameter \> 5 cm in at least 2 dimensions
* The patients have written informed consent
* The patients is scheduled for elective craniotomy to remove tumor

Exclusion Criteria:

* Patients who refuse to participate in this study
* Patients with recurrent tumor
* The patient is set operation for intracranial tissue biopsy
* The patients with history of TXA allergy
* The pregnant patients
* The patients with history of significant thromboembolic episode
* The patients with significant renal dysfunction (GFR ≤ 50 ml/min)
A Clinical Trial to Evaluate the Safety and Immunogenicity of PPV23 Vaccine Revaccinated in 60-70 Years Old

Objective: To evaluate the safety and immunogenicity of PPV23 vaccine revaccinated in 60-70 years old in Shanghai.

1. Antibody double growth rate in 28-40 days after immunization;
2. Antibody GMC level in 28-40days after immunization;
3. Incidence of adverse reactions in 0-30days.

Eligibility Criteria:
Inclusion Criteria:

1. The age was 60-70 years old on the day of enrollment;
2. The subjects have signed the informed consent and signed the date;
3. The subjects are able to participate in all planned follow-up visits and were able to follow all trial procedures (e.g. complete diary card / contact card, return to visit);
4. The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years;
5. The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.

Exclusion Criteria:

1. With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
2. Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3.Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);

4.Administration of immunoglobulins within 30 days prior to this study; 5.Acute febrile disease(temperature ≥ 37.0°C) or infectious disease; 6.With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7.With any serious chronic illness, acute infectious diseases, or respiratory diseases; 8.Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes with complications; 9.With any kind of infectious, purulent, or allergic skin diseases; 10.With any other factor that makes the investigator determines the subject is unsuitable for this study.
To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed and Fasted Conditions

To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fed and fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Semi-inmersive Virtual Reality on Upper Limb in Multiple Sclerosis

Video games based on VR technology are emerging as valid tools used in neurorehabilitation for patients with neurological disorders, and as a low cost and easily accepted adjunct to traditional therapy. Standard games such as the Nintendo Wii, Playstation Move and Kinect plus XBOX 360 have been used in EM rehabilitation. However, often these are either too difficult for patients or the games progress too quickly, failing to provide impairment-focused training or specifically address patients' needs \[10\]. Therefore, it is necessary to develop specific serious games for EM patients. Serious games are defined as games designed for a primary purpose other than that of pure entertainment, and which promote learning and behavior changes for EM patients. In this context, gesture caption devices (such as MYO, LEAP or Joy Con´s Nintendo Switch), which uses a sensor that captures the movement of the patient's forearms and hands are really interesting in rehabilitation contexts. This generates a virtual image of the upper limbs on a computer screen and the patient is prompted to perform movements according to the functional task proposed. This system presents important advantages namely thanks to its portability, ease of use, commercial availability, low cost and non-invasive nature. However, evidence is lacking that supports the therapeutic use of semi-inmersive VR technology in the treatment of upper limb (UL) motor disorders in EM.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS according to McDonald's criteria.
* Assessment on the Kurtzke Scale of the State of Multiple Sclerosis Disability (EDSS) with a score between 1.0 and 7.5.
* Stable medical treatment for at least six months prior to the intervention.
* Muscle tone in the upper extremities not greater than 2 points (moderate hypertonia, increased muscle tone during most of the arc of movement, but the affected part can easily be moved passively) on the modified Ashworth Scale.
* Score less than or equal to 4 points in the section ¨Piramidal Function¨ of the functional scale of the EDSS.
* Absence of cognitive impairment, with the ability to understand the instructions and obtain a score equal to or greater than 24 in the Minimental Test.
* Score equal to or less than 2 points in the section ¨Functions Mental¨ of the EDSS.

Exclusion Criteria:

* Diagnosis of another neurological disease or musculoskeletal disorder other than MS.
* Diagnosis of any cardiovascular, respiratory or metabolic disease.
* Other conditions that may interfere with this study, having suffered an exacerbation or hospitalization in the last 3 months before starting the protocol of assessment, or during the therapeutic intervention process.
* Having received a steroid cycle, intravenously or orally, 6 months before the start of the assessment protocol and within the intervention period of study duration.
* Having received treatment with botulinum toxin in the six months prior to the start of the study.
* Presence of uncorrected visual disturbances through eye devices.
Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients

Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis

Patients with chronic kidney disease undergoing hemodialysis will be administered human recombinant alfa epoetin to revert anemia. Hemoglobin, hematocrit and reticulocyte counts will be assessed. Immunogenicity will be evaluated through bi-weekly Anti Drug Antibody determination. Test drug and comparator drug will be compared to evaluate biosimilarity.

Eligibility Criteria:
Inclusion Criteria:

* Stage V Chronic kidney disease undergoing hemodialysis

Exclusion Criteria:

* Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies
Effects of SUDOKU Mind Activation & Revitalizing Training on Cognitive Function in People With Mild Cognitive Impairment

This study aims to implement a SUDOKU Mind Activation and Revitalization Training (SMART) Program to promote cognitive health among patients with mild cognitive impairment (MCI), and the use of active mind strategy in preventing dementia among the older adults. The SMART Program consists of two components including, a community empowerment-educational campaign on active mind strategies for older adults, and a 24-week SUDOKU Training Programme for people with MCI.

This study aims to implement a SMART Program to promote cognitive health among patients with MCI, and the use of active mind strategy in preventing dementia among the older adults. The SMART Program consists of two components including, a community empowerment-educational campaign on active mind strategies for older adults, and a 24-week SUDOKU Training Programme for people with MCI.

The community empowerment-educational campaign will be conducted in the elderly care centres of the two collaborating non-governmental organizations, with the purpose of increasing the awareness of people aged 55 or above on the importance of maintaining an active mind and preventing age-related cognitive decline and dementia. The campaign will include cognitive screening, poster exhibition, booth exhibition and individual counselling.

The SUDOKU training program include a 12-week face-to-face training session and a 12-week facilitated self-practice. The face-to-face sessions aim at developing the skills of the participants in solving the SUDOKU using the T-code. The 12-week training program will be evenly divided into three modules of increasing difficulty, with consideration given to the suboptimal cognitive function of the participants with MCI. These modules are developed by the Co-investigator who has rich prior experience in teaching older adults on SUDOKU puzzle.

Eligibility Criteria:
Inclusion Criteria:

* People with MCI as defined by a score of 19-26 out of the 30 on the Montreal Cognitive Assessment in the general public and aged 55 or above.

Exclusion Criteria:

* Persons with dementia and communication problems will be excluded.
Combination Chemotherapy in Treating Women With Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether doxorubicin plus docetaxel is more effective than doxorubicin plus cyclophosphamide for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of doxorubicin in combination with either docetaxel or cyclophosphamide in treating women who have previously untreated, advanced, or inflammatory breast cancer.

OBJECTIVES: I. Compare the efficacy (response rate) and toxicity of doxorubicin in combination with either docetaxel or cyclophosphamide as primary therapy regimens in patients with locally advanced or inflammatory breast cancer.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center and operability. Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel IV followed by doxorubicin IV once every 3 weeks. Arm II: Patients receive doxorubicin IV and cyclophosphamide IV once every 3 weeks. Patients receive a maximum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity. Patients then undergo surgery (if operable) followed by more chemotherapy (if node positive), radiation therapy, and oral tamoxifen for 5 years (at the discretion of the investigator for estrogen receptor-negative patients). Patients are followed at 12, 18, and 24 months, and then annually for at least 5 years.

PROJECTED ACCRUAL: A total of 350 patients (175 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven previously untreated locally advanced or inflammatory breast cancer Potentially operable disease Tumor at least 3 cm in diameter No metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 60 Sex: Female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: PT and aPTT normal Bilirubin normal (except in patients with benign congenital hyperbilirubinemia) AST/ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN No active hepatitis B or C Liver biopsy normal (if positive serology for hepatitis B or C) Renal: Creatinine normal Cardiovascular: Adequate cardiac function No active cardiac disease Other: Not pregnant Fertile patients must use effective contraception No other serious medical or psychiatric disease No prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior therapy for breast cancer
Study Evaluating DVS-233 SR And Venlafaxine ER In Adult Outpatients With Major Depressive Disorder

To compare the antidepressant efficacy and safety of DVS-233 SR with those of placebo in adult outpatients with MDD.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 75 years of age, inclusive.
* Sexually active individuals participating in the study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article
* Subjects must have a primary diagnosis of major depressive disorder

Exclusion Criteria:

* Treatment with DVS-233 SR at any time in the past
* Treatment with venlafaxine (immediate release \[IR\] or extended release \[ER\]) within 90 days of study day 1
* Known hypersensitivity to venlafaxine (IR or ER)