cyrilzakka/clinical-trials huggingface dataset:
Low-protein Formula Supplements in Chronic Kidney Disease

Prospective randomized contorl study.Comparing clinical outcome between chronic kidney disease who were prescribed 6% low-protein nutrition supplement along with dietatian regular nutrition education and those without oral nutrition supplement.

Past studies have shown that supplementation with low-protein nutritional formulas helps to increase compliance with low-protein diet control, but few studies have explored low-protein nutritional formulas supplementing the calories chronic kidney disease patient need, and nutritional supplements rich in ω-3 fatty acids, vitamin D and essential amino acid having effect in chronic renal function and changes in muscle mass, strength, and mobility. The propose of this study that low protein supplement may help maintain renal function or delay deterioration of renal function, or may reduce the risk of malnutrition and further improve muscle strength and mobility or quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \>65years of age.
2. Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3 to 5.

Exclusion Criteria:

1. The physician determines that the clinical condition is unstable.
2. Lower limb injury or severe edema.
3. food allergies to milk, or fish
4. There is a heart rhythm in the body and a prosthetic device.
5. Those who are unable to complete the questionnaire due to severe cognitive impairment as determined by the physician.
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
* Moderately to severely active UC as assessed by the modified Mayo score
* Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
* If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria:

* Has severe extensive colitis as defined in the protocol
* Extent of inflammatory disease limited to the rectum
* Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
* Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
* Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement (Part A), and in participants with active cutaneous lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE, including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of BIIB059 (Parts A and B).


Eligibility Criteria:
Key Inclusion Criteria:

Part A:

1. Diagnosis of systemic lupus erythematosus (SLE) fulfilling at least 4 out of 11 of the 1997 revised American College of Rheumatology (ACR) classification criteria for SLE along with active skin manifestations and joint involvement.
2. At least 4 tender joints and at least 4 swollen joints with at least 4 of the swollen joints in the proximal interphalangeal (PIP) joints, metacarpophalangeal (MCP) joints and/or wrist.
3. Demonstrate at least one sign of active lupus skin disease, including acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), and/or chronic cutaneous lupus erythematosus (CCLE) (e.g., discoid lupus erythematosus (DLE)), with skin activity defined by SLE Disease Activity Index 2000 (SLEDAI-2K) at the time of Screening and randomization.

Part B:

1. Active skin manifestations Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) ≥8)) and a diagnosis of cutaneous lupus erythematosus (CLE) that has been histologically confirmed (in the past or at Screening), with or without SLE manifestations.

Key Exclusion Criteria:

1. Active lupus nephritis or moderate-to-severe or chronic kidney disease.
2. Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
3. History of chronic, recurrent (3 or more of the same type of infection in a 12-month period), or recent serious infection (e.g., pneumonia, septicemia, herpes zoster) as determined by the Investigator and requiring anti-infective treatment within 12 weeks prior to Screening.
4. Use of immunosuppressive or disease-modifying treatments for SLE or CLE that were initiated less than 12 weeks prior to Randomization.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Age-related Changes in Ovarian Follicular Wave Dynamics

The investigators hypothesize that age-related changes in the number and growth dynamics of ovarian follicles will be associated with changes in hormone levels and corresponding changes in musculoskeletal health.

The following hypotheses will be tested:

1. Differences in ovarian follicular wave dynamics will be detected in women of different ages;
2. The numbers and patterns of ovarian follicle waves in women are repeatable over multiple menstrual cycles;
3. Differences in inhibin B, inhibin A, and AMH will be detected in women with 2 versus 3 or more follicular waves
4. Differences in FSH, LH, progesterone, inhibin B, inhibin A, and AMH detected in MRA and LRA2 women, will change with the numbers of follicles and waves detected;
5. 'Luteal out of phase events' (aka LOOP cycles) will be more prevalent in LRA2 versus MRA women, and will represent major anovulatory waves and/or ovulatory waves;
6. When compared to MRA group, LRA2 women will have lower bone mineral mass and areal density at the lumbar spine; reduced trabecular density at the distal radius and thinner cortices with lower cortical density at the radial and tibial shaft. Other bone outcomes will be similar between the groups;
7. When compared to MRA group, LRA2 women will have lower total body lean mass, greater fat mass and less dense muscle tissue at the forearm and lower limb and lower hand grip strength.
8. Reduced bone mineral mass, areal density, trabecular density, cortical density and hand grip strength in LRA2 versus MRA women will be associated with reduced follicle number, a greater prevalence of LOOP cycles, higher serum FSH and lower inhibin concentrations

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained
* Age of 18-55
* 18\<BMI\<35
* Menstrual cycle history:
* MRA group: regular cycles
* LRA-1 group: history of regular cycles, with variable cycles allowed (no more than 3 months amenorrhea)
* LRA-2 group: variable cycles allowed (no more than 3 months amenorrhea)
* Has not taken hormonal contraception within 2 months of initiating study procedures
* Agrees to use back-up contraception throughout the course of the study, if sexually active (condoms to be provided)
* 3.0 \< Prolactin \< 20.0 ug/L
* 0.30 \< TSH \< 5.50 mIU/L
* Normal complete blood count (CBC)
* Beta human Chorionic Gonadotropin \< 5IU/L.

Exclusion Criteria:

* Smokers
* Documented ovarian failure
* History of or currently-diagnosed infertility of unexplained or female origin;
* Medical conditions known or suspected to interfere with reproductive function (including PCOS)
* Presence of only one ovary
* Ovaries inaccessible with transvaginal ultrasonography
* The use of any medications known or suspected to interfere with reproductive function
* Ongoing pregnancy
* Lactation
* Participation in an investigational drug trial in the 30 days prior to the pre-study visit
* Planning to undergo surgery during the course of the study.
Geneexpression as a Marker of Embryo Viability

The aim of the post doc project is investigate which genes regulate implantation in order to analyze specific proteins and microRNA in the spent culture media with the long-term goal of developing a non-invasive method of embryo assessment and selection. This will be achieved by conducting a targeted NGS analysis, based on list obtained from a non-published pilot study. When further validated by q-PCR, the expression of specific microRNAs known to influence the final list of genes will be analyzed in the spent culture media and the protein products of the genes recovered from the media will be quantified. The level of specific microRNAs and proteins will be related to aneuploidy and implantation potential. If the level of specific microRNA and/or proteins correlates with pregnancy, the study will form the basis for developing a clinical applicable precise method of improved embryo selection and thus improved IVF treatment.


Eligibility Criteria:
Inclusion Criteria:

* \>5 oocytes retrieved

Exclusion Criteria:

* endometriosis
Pivotal Response Treatment for Individuals With Intellectual Disabilities

The investigators will assess the efficacy of Pivotal Response Treatment (PRT) in the treatment of communication deficits in children with intellectual disabilities. By collecting information about parent and child functioning before and after PRT, The investigators will be able to determine whether the intervention is effective in improving child communication and reducing parent stress.


Eligibility Criteria:
Inclusion Criteria for Individuals with Intellectual Disabilities:

* Participants will have an age range between 2 and 17.11 years of age inclusive
* Male or female
* Diagnosis of an intellectual disability based on the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10), and an expert clinical evaluation
* have historical evidence of significant abnormal developmental milestones as determined by neurological history
* care provider that will reliably bring subject to study visits, and is trustworthy to provide accurate accounts of services provided to the subject

Inclusion Criteria for Individuals with Speech Delay/Language Disorder:

* Participants will have an age range between 2 and 17.11 years of age inclusive
* Male or female
* Diagnosis of a speech delay based on the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10), and an expert clinical evaluation
* Preschool Language scale (PLS) score of at least 1 standard deviations below age level (for children in the age range of 2-6.11)
* care provider that will reliably bring subject to study visits, and is trustworthy to provide accurate accounts of services provided to the subject

Exclusion Criteria:

* medically unstable (such as having unstable seizures)
* primary diagnosis of Autism Spectrum Disorder (ASD) is exclusionary as determined by the investigators
Rapid Development and Implementation of a Remote ECG-monitored Prospective Randomized Clinical Trial During a Pandemic: Hydroxychloroquine Prophylaxis in COVID-19 Household Contacts

* organizing an entirely no in-person contact clinical trial is feasible during a 22 COVID-19 pandemic 23
* Remote smartphone 6-lead ECG monitoring is possible even in a group unfamiliar 24 with the technology 25
* Hydroxychloroquine used prophylactically at 200 mg BID had no observable 26 cardiotoxicity 27
* Additional study using this technique is warranted to look at reliability and cost-28 effectiveness

Household members were contacted by telephone and provided consent forms via E-mail electronic signatures. Randomization was 2:1 to HCQ 200 mg BID or observation for 10 days with total follow-up of 14 days. COVID status was determined by home saliva PCR assay on days 1 and 14. Study drug was shipped to participants. Data of daily symptoms and 6-lead ECGs using a smartphone KardiaMobile® 6L application were collected.

Eligibility Criteria:
Inclusion Criteria:

* exposure to a COVID-19-infected individual in the same household within five days of diagnosis;
* age \>18 years;
* ability to give informed consent to participate in a clinical study;
* ability to swallow oral medications;
* access to a smartphone

Exclusion Criteria:

* allergy or intolerance to hydroxychloroquine (PlaquenilR);
* weight less than 85 pounds;
* eye disease affecting the retina;
* severe kidney or liver disease;
* G6PD-deficiency;
* porphyria;
* long QTc EKG abnormality or family history of this;
* other major EKG abnormalities;
* taking medications that can affect the QT interval including flecainide, amiodarone, digoxin, procainamide, propafenone, sotalol, quinidine, dofetilide, levofloxacin, ciprofloxacin, azithromycin, erythromycin, amitriptyline, doxepin, desipramine, imipramine, fluoxetine, sertraline, venlafaxine, quetiapine, haloperidol, droperidol, thioridazine, ziprasidone, furosemide, sumatriptan or zolmitriptan, cisapride, arsenic, dolasetron, or methadone;
* current pregnancy;
* current hospitalization;
* symptomatic with fever or cough;
* lack of access to a smartphone
Different Surgical Approaches in Patients of Early-stage Cervical Cancer

This multi-center, randomized controlled study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between Chinese uterine cervical patients receiving different surgical routes (laparotomy and laparoscopy) for radical hysterectomy or trachelectomy, which is the primary study objective. All patients with uterine cervical cancer of FIGO stage IA1 (with lymphovascular space invasion), IA2 and IB1 will be included and randomized into two groups: laparotomy and laparoscopy groups for radical hysterectomy or trachelectomy. Secondary study objectives include: patterns of recurrence, treatment-associated morbidity (6 months from surgery), cost-effectiveness, pelvic floor function, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
* FIGO stage IA1 (with lymphovascular space invasion), IA2 or IB1
* Type II or III radical hysterectomy or trachelectomy
* Performance status of ECOG 0-1
* Aged 18 years or older
* Signed an approved informed consents

Exclusion Criteria:

* Not satisfying any of the inclusion criteria
The Evaluation Studies of Curative Effect of Fu-zheng-qu-zhuo Oral Liquid in Treatment of Ischemic Nephropathy

• Background: Since evidence show that renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal-artery stenosis\[1\], the aim of our study was to confirm Fu-zheng-qu-zhuo (FZQZc) oral liquid, a herbal medicine, combined with optimal medical therapy of internal medicine (OMT), including anti-platelet therapy and other protocol-driven medical therapies to control blood pressure and glucose and lipid levels in accordance with guidelines,resulted in greater renal function protection in patients with atherosclerotic renal artery stenosis ( ARAS) compared with OMT alone.

Methods : A randomized, placebo-controlled, single centre clinical design. Sixty patients with diagnosed atherosclerotic renal artery stenosis and had chronic kidney disease stage 3 will be recruited, and will be randomized into two groups in a 1:1 ratio ( FZQZ and placebo Group, 30 respectively). FZQZ Oral liquid or placebo 20 ml every time, three times a day for different groups, meanwhile, all participants in both treatment groups received OMT, 6 months therapeutic period. Serum creatinine, estimated glomerular filtration rate(eGFR), urine protein, and cardiovascular and renal events (a composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy) will be compared between the Groups as the outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Met the ARAS diagnosis: renal angiography or magnetic resonance angiography (MRA) shows renal artery with unilateral or bilateral stenosis at least 50%，and with artery atheromatous plague;
2. Meeting with the diagnostic criteria of the K/DOQI chronic kidney disease （eGFR\<90ml/min）：light or moderate damage to kidney function，Scr\<265.2µmol/L(3.0mg/dl).

Exclusion Criteria:

1. Patients with renal artery stenosis which had been suspected or final diagnosed to be Fibromuscular dysplasia or Takayasu arteritis;
2. Blood pressure did not meet the target (\<140/90mmHg) after combinedly taking more three kinds of antihypertensive agents with maximum dose;
3. Poor control of blood sugar in patients with Diabetes ( glycosylated hemoglobin 8.0% or higher in the recent month);
4. History of peptic ulcer，with Gastrointestinal bleeding in the recent 6 months;
5. decompensated cirrhosis;
6. Hematologic disease or bleeding tendency;
7. Repeated episodes of pulmonary edema, congestive heart failure, acute myocardial infarction, cerebral infarction and cerebral hemorrhage in recent 3 months;
8. Suffering from malignant tumor and predicting life span less than 1 year.
Quality of Life, Lifestyle, and Psychosocial Factors in Patients With Melanoma

This study investigates the extent to which lifestyle factors including mental health, social support, diet, and exercise are associated with quality of life and melanoma patient outcomes. Knowledge gained from this study may be used to guide the design of prospective clinical trials of lifestyle interventions to improve the outcomes of melanoma patients and assist doctors in counseling their patients.

PRIMARY OBJECTIVES:

I. Collect systematic data on mental health, quality of life (QOL), social support, diet, and exercise behaviors in melanoma patients.

II. Examine whether psychosocial factors and lifestyle are associated with clinical outcomes in melanoma patients.

III. Examine the association between lifestyle and psychosocial factors and tissue and blood biomarkers in melanoma patients.

IV. Examine whether psychosocial factors and lifestyle are associated with QOL adjustment in melanoma patients.

OUTLINE:

Patients complete a maximum of 3 paper or electronic questionnaires over 30 minutes within 2 weeks of presentation to MD Anderson, new diagnosis of melanoma, and/or initiating a new treatment, within 2 weeks of first restaging, and within 2 weeks of the end of treatment. Patients may complete an additional paper or electronic dietary questionnaire over 10 minutes for 3 days (30 minutes total) or a phone-based dietary recall. Patients who start a new treatment of interest may repeat the questionnaires at the same time points. Patients' medical records are also reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of melanoma, precursor lesions, and associated cutaneous pathology
* Able to read and understand English
* Willing to complete an online or paper survey
RT-PCR on Conjunctival Sample for the Detection of SARS-CoV-2 in Patients With Covid-19

the purpose of the study is to study the detection of SARS-Cov-2 virus in the conjunctiva of covid-19 patients and the presence or absence of conjunctivitis in these patients


Eligibility Criteria:
Inclusion Criteria:

* Men and Women positive for SARS-Cov-2 on a RT-PCR test of a sample of respiratory airway
* Persons over 18 years of age
* patients of both sexes
* Member of a social security scheme
* Having signed the consent form

Exclusion Criteria:

* Minors not emancipated, persons out of state to express their consent
* Participation in intervention research on Covid-19 involving experimental treatment
* History of chronic disease conjunctiva
* Patient with one of the one of the criteria of following gravity:

  1. EN \> or =30/min,
  2. Pao2/Fio2 = or \< 300,
  3. confusion and/or disorientation,
  4. hypotension (Tas90mmhg, requiring aggressive filling),
  5. need for a invasive ventilation,
  6. septic shock
ECM and Blood Components for Wound Healing

The Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM) and autologous blood products in wound healing.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes, and/or venous insufficiency to the affected leg
* Ulcer has been present between 12 and 52 weeks
* Ulcer is less than 40 cm2 in area

Exclusion Criteria:

* Less than 18 years of age
* Pregnant or planning to become pregnant during the study period
* Simultaneously participating in another investigational drug or device study
* Unable or unwilling to comply with the weekly study follow-up schedule or off-loading regimen
* Patient or legal representative refuses to sign the EC-approved informed consent form
* Known allergy to pig or porcine products
* Additional criteria may apply
Evaluation of the Serum Markers sFLt1 and PlGF for the Prediction of the Complications of the Placental Vascular Pathologies in the 3rd Quarter of the Pregnancy.

The pre-eclampsia is a frequent pathology, concerning approximately 5 % of the pregnancies.The pre-eclampsia can evolve into severe maternal and\\or foetal complications and is a major cause of mortality.

The purpose of the study will to estimate the relevance of the serum markers sFlt1 and PlGF to predict the arisen of severe complications at these patients, what would allow to decrease the materno-fœtale morbi-mortality due to the pathology.

The pre-eclampsia is a frequent pathology, concerning approximately 5 % of the pregnancies. It is a major cause of mortality, mainly in the developing country. His incidence tends to increase in the developed countries. In the absence of adapted coverage, the pre-eclampsia can evolve into severe maternal and\\or foetal complications (eclampsia, foetal intra-uterine, dead HELLP syndrome, lung acute oedema, stunting in utero).

The pre-eclampsia is a part of placental vascular pathologies. Several studies showed that these pathologies are due to a defect of trophoblastic invasion, secondary in an imbalance in the balance of factors pro and antiangiogéniques (PlGF, sFlt1).

Studies also demonstrated that, for a patient presenting a placental vascular pathology, the rate of PlGF is decreased and conversely for the rate of sFlt1. Studies show that the duration of the pregnancy, of a patient presenting a placentary vascular pathology, is correlated at the rate of these markers.

There is at present no reliable predictive examination to estimate the arisen of severe complications for a patient presenting a placental vascular pathology. The purpose of the study will to estimate the relevance of the serum markers sFlt1 and PlGF to predict the arisen of severe complications for these patients.

Eligibility Criteria:
Inclusion Criteria:

* pregnant woman with a diagnosis of placental vascular disease (gestational hypertension, preeclampsia, IUGR)

Exclusion Criteria:

* patient who refuses the obstetric follow-up