cyrilzakka/clinical-trials huggingface dataset:
Functional Tests in Individuals With Chronic Obstructive Pulmonary Disease (COPD)

Objectives: to evaluate and compare the responses to the various functional tests, and the concordance between the six-minute walk test in hallway (6MWT) and the of oval track (6MWToT), of treadmill (6MWTT), and of treadmill with inclination (6MWTTI), the six-minute step test (6MST) and the sit-to-stand test (STST), in patients with Chronic Obstructive Pulmonary Disease (COPD), and to correlate the responses with functional state and quality of life. Methods: Ten patients with COPD (71±8years, FEV1\<80%predicted) were assessed using the functional tests. A dyspnea was assessed using the London Chest Activity of Daily Living and the Medical Research Council scales; and the quality of life was assessed using the St George's Respiratory Questionnaire (SGRQ).

Results: In the interests analysis, there was lower walking distance in the 6MWTT and 6MWTTI was observed, to compare in the 6MWT and 6MWToT; the ΔSp,O2 (delta of arterial oxygen saturation measured by pulse oximeter) in the 6MWTTI was significantly greater that in the 6MWT, but not between to change in dyspnea and fatigue/pain in the lower-limbs between rest and exercise of peak (Δ). Concordance and correlation was observed between the lower Sp,O2 of the 6MWT with the 6MWToT, 6MWTT, 6MWTTI, 6MST and STST. Strong correlations was observed between the performances on the 6MST and 6MWT, 6MWToT and 6MWTT; and between the physical activity domain of the SGRQ with the performances in the 6MWT, 6MWToT, 6MWTT,6MST and STST. Conclusion: The functional tests produced similar subjective responses; however, the 6MWTTI caused greater desaturation that 6MWT. The concordance between the 6MWT and the tests performed, suggests acceptable use of any these tests in the physiotherapeutic clinical routine of the individuals COPD. The tests in performed, except the 6MWTTI, shown to be indicators of the quality of life (physical activity domain).

Eligibility Criteria:
Inclusion Criteria:

* Tiffeneau index\<70% e 30%\<FEV1\<80% predict;
* no presenting exacerbation during the study period;
* clinical stability for the four weeks preceding the study outset;
* no-smokers or ex-smokers.

Exclusion Criteria:

* being incapable of understanding the scales and questionary;
* being unable to perform the tests.
Peripartum Cesarean Hysterectomy for Placenta Percreta

The aim of this study is to address the possible preoperative determinants of extrauterine diseases in cases of placenta previa percreta and to compare the operative and postoperative characteristics of cases with and without extrauterine disease.

This will be a retrospective study of the data of women who underwent cesarean hysterectomy on placenta previa percreta who were classified as Federation of Gynecology and Obstetrics (FIGO) grade 3. Women without extrauterine disease (FIGO grade 3a) will be compared to women with extrauterine disease (FIGO grades 3b and 3c)

Eligibility Criteria:
Inclusion Criteria:

* Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3).

Exclusion Criteria:

* Medical conditions complicating pregnancy.
* Blood diseases or bleeding tendencies
Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of one of the following

  * Newly diagnosed de novo acute myeloid leukemia (AML)
  * AML secondary to myelodysplastic syndromes (MDS)
  * AML secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years
* Bone marrow blasts \>30%
* Age ≥ 65 years
* Easter Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

* Previous cytotoxic or biologic treatment for AML (except hydroxyurea)
* Previous treatment with azacitidine, decitabine or cytarabine
* Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors)
* AML French American British subtype (FAB M3)
* AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes
* Prior bone marrow or stem cell transplantation
* Candidate for allogeneic bone marrow or stem cell transplant
* Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)
* Malignant hepatic tumors
* Uncontrolled systemic infection
* Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or C
* Use of any experimental drug or therapy within 28 days prior to Day 1
Low GI Diet in Children and Adolescents With ALL

The study aims to determine the feasibility of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for acute lymphoblastic leukemia.

Acute lymphoblastic leukemia (ALL) is the most common childhood malignancy with survival exceeding 90%. However, treatment-related toxicity remains a clinical challenge during and after treatment. Evidence-based, nutritional interventions may minimize the development of nutrition-related toxicities, such as bone morbidities, hypertriglyceridemia, and obesity. To date, no effective interventions are available to prevent nutrition-related morbidities in children with ALL. Clinical studies evaluating the glycemic indices in other pediatric conditions have been encouraging. It is plausible that reducing the glycemic indices of diets during cancer treatment may have a profound clinical effect in this vulnerable pediatric population. Prior to the design and implementation of randomized, controlled trials, epidemiological data describing the Glycemic Index (GI) and Glycemic Load (GL) and the association with clinically important outcomes is needed. Additionally, the feasibility of a dietary intervention must also be explored within the setting of pediatric cancer. This study aims to determine the feasibility, measured by compliance to a low-GI diet, of a 6-month low glycemic dietary intervention in children and adolescents undergoing treatment for ALL. The proposed work will be used for the design and implementation of a multi-center nutritional intervention aimed at improving dietary intake during treatment and its effect on clinically important outcomes. Importantly, the information will be used to drive the formation of evidence-based nutritional guidelines for children with cancer, which will expand into the emerging field of individualized medicine for patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute Lymphoblastic Leukemia (B-Cell, T-Cell, or Mixed Phenotype)
* Within 3 days of starting the induction phase of treatment for Acute Lymphoblastic Leukemia
* Proficient in English or Spanish

Exclusion Criteria:

* Diagnosis of relapsed Acute Lymphoblastic Leukemia
* Not meeting all of the inclusion criteria
Observation and Evaluation of Short-term Curative Effect of Local Advanced Cervical Cancer Treated With Particle Radiotherapy Versus Neoadjuvant Chemotherapy

Locally advanced cervical cancer (LACC) refers to the clinically cervical visible lesion with a diameter of \> 4 cm, which has been considered as a high risk of early cervical cancer for a long time. Because of local bulk lesion of LACC, the risk of radical hysterectomy is pretty high and the radical effect commonly does not meet the satisfactory. Therefore, 1-3 course of neoadjuvant chemotherapy (NACT) were carried out before operation. However, nearly 20% of patients are not sensitive to NACT. Therefore NACT did not bring any benefits to radical surgery even to some extent delayed the treatment.

Traditional radiotherapy is also commonly used in the treatment of LACC, however ovarian function would be permanently destroyed especially for young patients, additionally radioactive complications to adjacent organs of cervical such as vagina, bladder and rectal also commonly happened, moreover sexual dysfunction after radiotherapy significantly affect the life quality of young patients.

Particle radiotherapy developed recently, has the advantages of short course of treatment and mild side effects, due to its special working mechanism, Bragg effect. So the amount of radiation in the tumor tissue is very extremely high, and in the adjacent tissue is quiet low, therefore the organs at risk were protected by avoiding unnecessary damage.

Based on these, we proposed the application of particle radiotherapy in LACC pre-operation, and comprehensively evaluated recent curative effect, complications and long-term follow-up between particle radiotherapy and NACT. Furthermore, the clinical significance and long-term application prospects about particle therapy were objectively assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological diagnosis: squamous carcinoma, adenocarcinoma, adenosquamous carcinoma
2. The pathological staging: IB2，IIA2

Exclusion Criteria:

Underwent surgery or radiation and chemotherapy
Prospective Evaluation of the Results of Multidisciplinary Follow-up After a Transitional Consultation for Esophageal Atresia

A transition consultation for adult patients with esophageal atresia, involving medical and paramedical stakeholders, was set up at Hôpital Saint-Louis in 2020. The aim of this initiative is to: 1. initiate adult medical, psychological and social follow-up; 2. empower these adults in their future care; 3. establish a personalized follow-up schedule. This project is the first to focus on post-traumatic stress disorder (PTSD) in young adults with esophageal atresia. A 3-year analysis of the somatic and psychosocial variables analyzed will confirm the validity of this initiative, and define its optimal contours for improving these patients' quality of life as adults.


Eligibility Criteria:
Inclusion Criteria:

* Patients with esophageal atresia
* Aged 18 to 30
* Followed at Hôpital Saint Louis
* Informed and not opposed to the study
* Patients affiliated to a social security scheme

Exclusion Criteria:

* Inability to answer questionnaires
* Patients under guardianship
* Patients under AME (Aide Médicale d'Etat in France)
New "in Vitro" Diagnostic Test for Oral Malodour

This study will assess the ability of a first prototype (strip) of a new chair side test to detect oral malodour. The strip is based on a new enzymatic reaction able to detect amines in saliva. Previous studies already showed significant correlations between oral malodor and the levels of amines in saliva. The limitation in their use as markers of oral malodour is the fact that the detection is usually carried out by complex techniques (High Performance Liquid Chromatography(HPLC)and Solid-Phase Micro Extraction-Gas Chromatography/Mass Spectrometry (SPME-GC/MS)). The results of the new enzymatic reaction can be evaluated by means of a colorimetric scale without necessity of extra apparatus.

The study will be carried out with volunteers recruited at a multidisciplinary consultation for bad breath, organized at the University Hospital Leuven, Belgium.

The paper strip will be used before the routine evaluation (organoleptic score (OS), the gold standard method for the diagnosis of halitosis and the level of volatile sulphur compounds (VSC), the most used adjunct tool to diagnose halitosis).

The results of the new chair side test (strip) will be correlated with the OS and VSC measurements (OralChroma™, Halimeter®). The sensitivity, specificity and positive and negative predicted values of the new chair side test will be calculated. The cut-off values for a yes/no test will be determined. The meaning of color scores will be analyzed to assign a meaningful outcome to each score with relation to odor intensity.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years
* With no evidence of bad breath or bad breath of intra-oral cause (oral malodour)
* Non-smokers or smokers from whom the organoleptic evaluation can be performed (no interference from smoke odour)

Exclusion Criteria:

* Smokers from whom the organoleptic evaluation can not be performed because of interference from smoke odour
* Presence of active caries
* Presence of sinusitis or any other Oro-pharyngeal problem
* On medications which can cause malodour
* Reduced salivary flow due to pathological reasons (e.g. Sjögren syndrome)
* Any oral pathophysiological condition or any oral disease (e.g. oral cancer, mucositis)
* Pregnancy and nursing
* Situation considered not compatible with the study according to the investigator's opinion; the latter includes: persons under homeopathic therapy, patients who used antibiotics during the 2 months before the study, patients frequently using chewing gum, patients under corticosteroids or other serious medications.
Development of an AI App to Improve Compliance in Periodontal Maintenance Patients

An Artificial Intelligence platform to develop an app which improves compliance in periodontal treatments

To develop the accuracy of an AI-determined decision-making process for compliance score (CS) assignment, to assess clinical efficacy, and develop patient reported outcomes of AI-facilitated communication / education on a subject's oral health behaviors over successive maintenance visits.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 to 75-yrs of age
2. Subjects with diagnosis and treatment of Generalized and/or Localized Periodontitis Stages I, II, or III; grades A-C and or Peri-implantitis (Generalized Mild, Moderate, or Advanced Chronic Periodontitis) who are following a periodontal maintenance interval of every three months.
3. Subjects are able to provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
4. Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
5. Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

1. Subjects who do not own or are incapable of interacting with a smart phone or device
2. Subjects who are incapable of operating an application on a smart phone or device
3. Subjects who are not compliant with periodontal maintenance / recall intervals (Based on Wilson's classification as any lack of compliance with their recommended maintenance interval- therefore exclude subjects who demonstrate erratic compliance or noncompliance)18
4. Subjects who require active periodontal therapy during the study
5. Subjects who are on immunosuppressive medications, chemotherapy, or radiation therapy which would adversely affect their periodontal stability.
6. Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
7. Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

   -

   Exclusion Criteria:

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Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine

The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by Sinovac Biotech Co., Ltd., and evaluate the non-inferiority of investigational vaccine against a post-market inactivated polio vaccine.

This study is a randomized, double-blinded, and positive-controlled clinical trial. A total of 1300 infants aged 2 months will be enrolled and assigned to 4 groups in a ratio of 1:1:1:1 to receive vaccination of 3 lots of investigational sIPV and control IPV manufactured by Sanofi Pasteur S.A respectively. Each subjects should finish the three-doses primary vaccination at the schedule of 2,3,4 months of age. Thirty-days safety observation after each dose of vaccination will be carried out. Venous blood should be collected from all the subjects before and 30 days after the three-doses primary vaccination, for the neutralizing antibody assay, and further to evaluate the immunogenicity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants aged 60-89 days;
* legal identity;
* Informed consent form has been signed by guardians.

Exclusion Criteria:

* Vaccination history of polio vaccine;
* Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc.;
* Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
* Autoimmune disease or immunodeficiency/immunosuppression;
* Serious nervous system disorders (epilepsy, convulsion or tic) or mental disorders;
* Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors;
* Receipt of immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis);
* Receipt of blood products prior to this study;
* Receipt of other study drugs within 30 days prior to this study;
* Receipt of live attenuated vaccines within 14 days prior to this study;
* Receipt of subunit or inactivated vaccines within 7 days prior to this study;
* Acute diseases or acute exacerbation of chronic diseases within recent 7 days;
* Axillary temperature \>37.0℃;
* Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
Cognitive Rehabilitation in Patients With Depression

Depression is a highly prevalent and debilitating mental disorder, ranked one of the leading causes of disability worldwide. Several studies have identified neuropsychological deficits in populations of depressed patients affecting domains including attention, memory and executive functioning. These deficits often persist even in patients whose depressive symptoms have remitted. Cognitive impairment in depression represent a core feature of depression, and a valuable target for intervention. Identification of methods that would lead to amelioration would be of great clinical interest, and cognitive rehabilitation (CR) could be a potential way of achieving this. To date few studies on cognitive rehabilitation in depression has been conducted, but the preliminary results are promising. Still the demonstration of long-term effects and evidence relating to improved daily life executive functioning (i.e., generalization) is lacking. In the present study different group-based cognitive rehabilitation interventions will be compared. The aim of the study is to investigate if a group-based "brain training" intervention can improve executive function in patients with active and remitted depression. Efficacy will be assessed immediately after intervention, but also six months after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Completed treatment for mild or moderate MDD
* Evidence of executive dysfunction in everyday life determined by (a) a structured interview or (b) a self-report Behavior Rating Inventory of Executive Function (BRIEF) T-score \< 55.

Exclusion Criteria:

* Cognitive, sensory, physical, or language impairment affecting the capacity to complete the training program.
* Premorbid neurological disease or insult and/or comorbid neurological disorder.
* Reported ongoing alcohol or substance abuse.
* Psychotic disorders.
* Actively suicidal.
* Personality disorder sever enough to interfere with the protocol.
* Not fluent in Norwegian language.
Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder

This is a phase II, randomized, single-blind, placebo-controlled study to examine whether cariprazine (1.5 or 3 mg/d) 1) alters brain and/or behavioral responses to probes of reward and inhibition and 2) decreases cocaine use in individuals with cocaine use disorder. Subjects will be tested as inpatients during fMRI sessions. After the 2-week inpatient/medication induction phase, study medication will continue for 8 outpatient weeks, during which time cocaine use will be tracked. Subjects will be monitored during a 4-wk followup phase thereafter.


Eligibility Criteria:
Inclusion Criteria (limited):

1. An informed consent voluntarily signed and dated by the subject.
2. Physically healthy males and females with cocaine use disorder.
3. Ability to read at or above eighth grade level and speak, understand, and write in English.
4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
5. Available for an inpatient stay, when applicable.

Exclusion Criteria (limited):

1. Certain psychological disorders that could put subjects at risk during participation in the study.
2. Certain lifetime or current medical disorders or conditions that could put subjects at risk during participation in the study.
3. Medical contraindications for MRI, when applicable.
4. Has received medication that could interact adversely with cariprazine within the time of administration of study agent based on the study physician's guidance.
The Effects of a Nutrition Supplement on Health Related Quality of Life

The purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.

After being informed about the study, participants will provide informed consent and be randomized to one of two groups: intervention or control. Those in the intervention group will consume two ounces of a superfoods drink each morning for 60 days. Outcomes will be assessed at baseline, on day 30 and on day 60.

Eligibility Criteria:
Inclusion Criteria:

* otherwise healthy
* adults living in the US
* is practicing adequate contraception or is abstaining from all activities which could result in pregnancy
* understands and agrees to comply with study procedures
* provides informed consent

Exclusion Criteria:

* smoker
* pregnant or may become pregnant
* currently breastfeeding
* currently taking antioxidant supplements
* underlying chronic health conditions
* COVID-19 diagnosis
* demonstrated inability to comply with study procedures
* history of allergy to citrus or berry fruits
* has participated in an interventional clinical study within 31 days prior to enrollment