cyrilzakka/clinical-trials huggingface dataset:
Maintenance Programme After Weight Loss

The aim of this study is to compare a weight reduction programme with and without a maintenance programme in patients with severe obesity.


Eligibility Criteria:
Inclusion Criteria:

* BMI 35 kg/m2 or more
* Age 18-65 years

Exclusion Criteria:

* Type 1 diabetes
* Major alcohol problem
* Acute psychic disease, eating behavior, pregnancy, severe disease (cancer, unstable coronary disease, severe liver or kidney disease), or the patient has been in this treatment within the past 5 years
Myofascial Release in Patients With Plantar Fasciitis

Background: Plantar fasciitis is the most common cause of heel pain in runners. No studies have described the short-term effects of myofascial release on plantar fasciitis using ultrasound.

Objectives: To describe the immediate sonoelastographic changes in the plantar fascia of amateur runners with fasciitis after applying a myofascial release technique.

Design: A single-centre, experimental and controlled study.

Method: Patients with plantar fasciitis and a group of healthy subjects will be examined using B-mode and real time sonoelastography scanning. Fascia thickness, echointensity and echovariation of the color histogram will be analyzed pre- and post intervention. A two-way (Group × Time) repeated measures ANOVA will be performed.

Participants

Subjects of the plantar fasciitis group (PFG) will be recruited in May2018 to apply to them a myofascial release technique.

Healthy volunteers without a history of plantar fascia disease will be recruited as control group (CG).

The examination will be included B-mode scanning and real time sonoelastography using an US scanner with linear array transducer (ML6-15). All examinations will be conducted by a sonographer with more than 10 years' experience in musculoskeletal imaging.

Using a standardized protocol three images of every pre-post intervention video will be stored uncompressed and with no losses in bitmap format (bmp), and the mean value of the histogram components will be used for statistical analysis. The examination protocol shows good reliability, and has been reported previously.

ImageJ 1.45 software will be used to perform quantitative analysis of gray-scale images and the color histogram of the elastogram.

Eligibility Criteria:
Inclusion Criteria:

* heel pain at the proximal fascia insertion
* worse pain when waking up in the morning or after a period of rest
* a visual analog score (VAS) of more than 4 on a scale of 10

Exclusion Criteria:

* Patients who had undergone surgery or steroid injections to the heel will be excluded.
Human Immunodeficiency Virus (HIV) Food Insecurities

The objectives of this study are to better understand how FI (food insecurities) contributes to the development of cardiometabolic comorbidities among PWH (People with HIV) and to test a novel bilingual FI intervention designed to reduce these comorbidities among food insecure PWH. The PI and staff will conduct this study in partnership with the Wake Forest Infectious Diseases Specialty Clinic, one of the largest Ryan White-funded clinics in North Carolina, which serves more than 2,000 PWH annually from a predominantly rural catchment area that includes South Central Appalachia. This area has high rates of both FI and HIV.

The proposed study the team has created a conceptually integrated, mixed methods study that includes

* Longitudinal data collection to explore the difference in the prevalence and incidence of cardiometabolic comorbidities between food secure and insecure PWH
* Implementation and evaluation of the weCare/Secure intervention designed to improve insulin sensitivity among food insecure PWH with prediabetes or Type 2 diabetes (T2DM)
* Semi-structured individual in-depth interviews to understand the effect of the intervention on FI and insulin sensitivity among participants in an randomized controlled trial (RCT) trial
* Broad dissemination of study findings to inform both research and clinical practice

Eligibility Criteria:
Inclusion Criteria:

* participant must be a patient of the Wake Forest Infectious Diseases Specialty Clinic
* be living with HIV
* ≥18 years of age
* provide informed consent

Exclusion Criteria:

* unable to speak English or Spanish
* have cognitive impairment that would prevent participation
Trajectory of Frailty and Cognitive Dysfunction in Older Adults

To explore the heterogeneity of the development trend of frailty and cognitive function of older adults.

According to the inclusion and exclusion criteria, the older adults will be selected from community health service centers in four districts of Beijing. Frailty and cognitive function of the older adults will be assessed for a 24-month longitudinal multi-time (baseline, 6, 12 and 24 months). The heterogeneity of the development trend of frailty and cognitive function will be explored, and the subgroups of joint development trajectory of frailty and cognitive impairment will be classified, so as to identify high-risk populations that need to be managed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 years.
* Older adults with clear consciousness, ability of simple written and verbal communication.
* They volunteered to participate in this study, and signed an informed consent.

Exclusion Criteria:

* A clear diagnosis of any type of dementia.
* There are neurological diseases that clearly lead to cognitive dysfunction, such as severe cerebrovascular disease, brain trauma, intracranial tumors, etc.
* They have been clearly diagnosed with mental disorders affecting cognitive function, including schizophrenia, depression, bipolar disorder, etc.
A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection

Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection (FRSW107) Secondary objectives: To assess Safety and Tolerability by monitoring FVIII recovery and adverse events in Severe Hemophilia A.


Eligibility Criteria:
Key Inclusion Criteria:

* The activity of the coagulation factor VIII (FVIII:C) \< 1%. Less than 6 years old Patients previously treated with FVIII concentrate (s) for a minimum of 50 exposure days (EDs) prior to study entry. 6 years old to 12 years old Patients previously treated with FVIII concentrate (s) for a minimum of 150 exposure days (EDs) prior to study entry.
* Normal prothrombin time or INR \< 1.3.
* Negative lupus anticoagulant.

Key Exclusion Criteria:

* Hypersensitive to any of the excipients of the test materials (e.g. allergic to murine or hamster origin heterologous proteins).
* History of hypersensitivity or anaphylaxis associated with any FVIII or II immunoglobulin administration.
* Current FVIII inhibitor-positive or history of FVIII inhibitor-positive.
* Other coagulation disorder(s) in addition to hemophilia A.
* Infusion of any products containing FVIII within 72 h prior to administration.
* Significant hepatic or renal impairment (ALT and AST \> 2×ULN; serum bilirubin level \> 2 × upper limit of normal (ULN), BUN \> 2×ULN, Cr \> 2.0 ULN).
* One or more clinically significant tests for Human Immunodeficiency Virus (HIV), Antisyphilitic spirulina (TPHA) and Hepatitis C Virus (HCV) Antibody.
* Patients who received any anticoagulant or antiplatelet therapy within one week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials.
* Patients having major surgery or receiving blood or bood components transfusion within 4 weeks prior screening or having planned major surgery schedule during the study.
* Patients who previously participated in the other clinical trials within one month prior to administration.
* Any life-threatening disease or condition which, according to the investigator's judgment, could not benefit from the trial participation.
* Patient who is considered by the other investigators not suitable for clinical study.
L-arginine Concentrations and CPS Polymorphisms in VLBW Infants

Plasma L-arginine concentrations are decreased in premature infants with necrotizing enterocolitis (NEC). A carbamoyl-phosphate synthetase 1 (CPS1) polymorphism has been correlated with low plasma concentrations of L-arginine in neonates (\> 35 weeks of gestation). Recently Moonen et al (Pediatr Res 2007; 62(2):188-90) described a correlation between this CPS1 T1405N single nucleotide polymorphism (SNP) and the presence of NEC in VLBW infants. However there is no data about the correlation between the plasma arginine concentrations and the T1405N SNP in the CPS-1 gene in VLBW infants. In the present project we postulate that T1405N SNP in the CPS-1 gene is associated with lower plasma arginine concentrations and is also a risk factor for the development of NEC.

Plasma L-arginine concentrations are decreased in premature infants with necrotizing enterocolitis (NEC). A C-to-A nucleotide transversion (T1405N) in the gene that encodes carbamoyl-phosphate synthetase 1 (CPS1), the rate-limiting enzyme in the urea cycle, has been correlated with low plasma concentrations of L-arginine in neonates (\> 35 weeks of gestation). Recently Moonen et al (Pediatr Res 2007; 62(2):188-90) described a correlation between this CPS1 T1405N single nucleotide polymorphism (SNP) and the presence of NEC in VLBW infants. However there is no data about the correlation between the plasma arginine concentrations and the T1405N SNP in the CPS-1 gene in VLBW infants. In the present project we postulate that T1405N SNP in the CPS-1 gene is associated with lower plasma arginine concentrations and is also a risk factor for the development of NEC.

Eligibility Criteria:
Inclusion Criteria:

* VLBW infants (\< 30 weeks and \< 1500 gram birth weight).

Exclusion Criteria:

* Blood transfusion, enteral or parenteral protein intake, or inhaled nitric oxide administration before time of the blood sample (obtained between 6 and 12 hours after birth).
* Parents not able to give informed consent.
Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma

This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed untreated NPC patients
* T1-2N1-3M0 or T3-4NxM0
* 18-70 years old
* with MRI examinations
* ECOG ≤ 2
* With written consent

Exclusion Criteria:

* With a second cancer
* Pregnancy
* With other severe diseases (blood,liver ,kidney or heart diseases)
* Could not be staged properly
* Without written consent
Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD

Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ESRD treated for at least three months with CAPD, as stated by the medical staff of the center;
* Stable clinical condition within four weeks before the screening period, certified by medical/surgical history, physical examination and laboratory exploration;
* Hemoglobin level ≥ 9g/dL;
* Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
* To understand and sign an informed consent form.

Exclusion Criteria:

* History of alcohol or drug abuse in the last six months before selection for the study;
* Androgen therapy in the last six months before selection;
* Active infections;
* History of congestive heart failure stage III and IV New York Heart Association (NYHA);
* History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection;
* Clinically relevant cardiac arrhythmia;
* Clinically relevant abnormalities of functional hepatic tests;
* Therapy with L-carnitine or its derivatives in the last three months before selection;
* Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception;
* Presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with the assessment of study parameters, especially if the life expectancy is less then one year;
* Participation in another clinical study within the past month;
* Known allergic reactions to L-carnitine or xylitol.
Interactive Stepping Exercise on Memory

This is a randomized controlled trail. A total of 28 individuals with aMCI will be randomly assigned to either the ISE group or control group. The ISE intervention conducts three times a week for 16 weeks. Outcomes are measured at baseline and after intervention. The primary outcomes are the Chinese version verbal learning test (CVVLT), selective reminding test (SRT), and logic memory test (Wechsler Memory Scale). The secondary outcomes are Montreal Cognitive Assessment (MoCA) for cognitive function, and trail making test Part A \& B (TMT-A \& B), Stroop test, and 25-item Executive Interview (C-EXIT 25) for executive function.


Eligibility Criteria:
Inclusion Criteria:

* Age≥50 years
* Complained of memory impairment
* Chinese Version Verbal Learning Test 10-minute delays ≤ 6 words
* MMSE score≥24 and CDR score=0.5
* Activities of daily living are intact
* DSM-IV criteria for the diagnosis of dementia is not met

Exclusion Criteria:

* Any significant neurologic disease other than suspected incipient Alzheimer's disease
* Psychotic features, contraindication of exercise... which could lead to difficulty complying with the protocol
Distress Tolerance and Buprenorphine

The investigators propose that inability to tolerate the distress of opioid withdrawal and the negative affect associated with early abstinence are key factors in early illicit opioid lapse and subsequent buprenorphine treatment drop-out. Our intervention aimed at increasing distress tolerance is designed to increase treatment adherence.


Eligibility Criteria:
Inclusion Criteria:

* initiating buprenorphine treatment (which requires meeting current criteria for a DSM-IV diagnosis of opioid dependence)
* plan to remain on buprenorphine for at least three months
* age between 18 and 65 years
* if female of childbearing potential -- must be using adequate contraception (an intrauterine device, oral contraceptive, depot contraceptive, a barrier method "every time," or hysterectomy) as assessed by the study physician
* has at least two persons they regularly contact and can provide contact information for them
* speaks English sufficiently to understand instructions and assessments.

Exclusion Criteria:

* current methadone maintenance treatment program participation
* medically necessary prescription opioid treatment (e.g., for chronic pain)
* current criteria for a DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, alcohol, stimulants, cocaine, inhalants, hallucinogens
* a diagnosis of organic brain disorder, bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder, or major depression (subjects who meet criteria for "substance-induced mood disorder," or dysthymia only will not be excluded)
* current suicidality on the Modified Scale for Suicidal Ideation
* use of daily psychotropic, antidepressant, or anxiolytic medication
* evidence of neuropsychological dysfunction as assessed by the study physician with confirmation with the Folstein Mini-Mental Status Examination
* anticipated major painful event (significant surgical procedure) in the coming 6 months
* probation/parole requirements that might interfere with protocol participation
* history of allergic reaction to buprenorphine or naloxone.
Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer

1. Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.

1. Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.
2. Determine a maximum tolerated dose of capecitabine in combination with vinorelbine and carboplatin for this patient population.
3. Determine the time to relapse after the administration of this regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have a histological diagnosis of breast cancer with metastasis.
* The metastatic disease should be confirmed by biopsy if clinically indicated.
* The patient must have measurable or evaluable disease.
* Age \> 18 years and \< 75 years.
* The patient may not have received prior therapy with vinorelbine, capecitabine, carboplatinum, or cisplatinum.
* The patient may have received herceptin previously.
* The patients must have previously received at least one cycle of chemotherapy.
* The patient must have received anthracycline and taxane containing chemotherapy in the past. This may be either in the adjuvant setting or for metastatic disease. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse/progression within 6 months of completing chemotherapy.
* Performance status \< 2.
* At least 3 weeks must have elapsed since the completion of prior radiation therapy, chemotherapy, or hormonal therapy. The patient must have recovered from all grade 3-4 associated toxicities at the time of registration. Measurable or evaluable disease must be outside the previous radiation field or a new lesion must be present.
* Patients must not receive concurrent hormonal, or biologic therapy, or radiation therapy to measurable or evaluable disease.
* The patient should not have uncontrolled CNS disease.
* Laboratory parameters: ANC \> l500/ l, Platelets \>100 000/ l, creatinine \< 2.0, bilirubin \< 2.0
* Informed consent.
Skin Sensitivity Acupuncture and Kinesiotherapy on Breast Cancer Patients Subject to Chemotherapy With Taxans

Objective: to compare different therapies employing acupuncture needles, silicon pellets and kinesiotherapy in breast cancer patients to taxane chemotherapy cycles. Methods:The present study will be carried out at the Oncomastology outpatient clinic of the UNIFESP (Federal University of São Paulo) Gynecology Department's Discipline of Mastology - Escola Paulista de Medicina (EPM) and the Oncology Clinic Associated Center of Oncology, located at Rua Gabriel Monteiro da Silva, 454. randomized clinical trial will be conducted to define the treatment. Patients will be allocated into three groups (Group A: Stiper, Group B: Acupuncture, Group C: Kinesiotherapy and Group D After treatment ) who will receive treatment once a week for eight consecutive weeks. Group - S-observation.124 patients will be randomized in one of the three groups, after having signed the Free and Informed Consent Form and agreed to participate in the project, will respond to the evaluation form and will be submitted to physical examination. Patients will be evaluated in the first and tenth sessions.

Keywords: Acupuncture, Breast Neoplasm, Chemotherapy.

Women will be recruited at the Oncomastology outpatient clinic of the UNIFESP (Federal University of São Paulo) Gynecology Department's Discipline of Mastology - Escola Paulista de Medicina (EPM) and Clínica de Oncologistas Associados Centro Integrado de Oncologia, located at Rua Gabriel Monteiro da Silva, 454. Patients will consecutively be selected by order of entry in the chemotherapy recorded in the log and randomized in one of three intervention groups. Complying with all the research's ethical aspects, the following procedures will apply: 1st clarify the study's objectives;2nd sign the Term of Free and Informed Consent, signed in two ways, as one stays with the patient; 3rd espond to the evaluation form in the following items: socioeconomic aspects, main complaint, family history, personal history, surgical data, pathological anatomy, radiotherapy, chemotherapy, hormone therapy, sensitivity and perimetry;4 th physical exams. Completed the FACT-TAXANE questionnaire. Patients will be evaluated in the first and tenth sessions.

Eligibility Criteria:
Inclusion Criteria:

* women over 18 years old
* women submitted to chemotherapy with taxanes
* the 1th cycle both neoadjuvant and adjuvant with staging from I to III no mental changes

Exclusion Criteria:

* Women with preexisting diseases such as locoregional or distant cancer, previous joint pain,
* rheumatic disease,
* who are not undergoing chemotherapy with Anthracyclics and / or Cisplatin
* acupuncture in another service in the last three will be excluded.
Chronic Obstructive Pulmonary Disease (COPD) History Assessment In SpaiN (CHAIN)

The research project CHAIN (COPD Assessment History in Spain): "A Multidimensional Study on the Evolution of Chronic Obstructive Pulmonary Disease (COPD)is a multicentre, observational study conducted in several areas of Spain aimed to better define COPD natural history and its phenotypes

Observational studies are needed to ascertain the natural history and progression of COPD, and to better define its phenotypes. These two aspects are considered fundamental to a proper evaluation of current (and future) COPD treatment options, and it could possibly justify the limited impact of recent major drug trials.

Currently, there remain gaps in the natural history of patients with COPD. Most data are from analysis of mild COPD patients or smokers, usually measuring only fall in FEV1, and both have significant limitations in design and interpretation.

Studies in more severe patients with COPD have also been conducted mainly by studying lung function, possibly influenced by the recommendations of current guidelines for disease management. In recent years, we have more longitudinal data on changes in exercise capacity, imaging, and biomarkers, among other variables of interest, but our knowledge is yet partial.

The research project CHAIN (COPD Assessment History in Spain): "A Multidimensional Study on the Evolution of Chronic Obstructive Pulmonary Disease (COPD) is a multicenter observational study that will follow prospectively two cohorts: a) a COPD group active or former smokers (COPD cohort) and b) a group of active smokers or former smokers without COPD (control cohort). Both cohorts will be followed up for a period of at least 5 years, with visits every 12 months (and phone controls at least every 6 months). We will try to extend the monitoring of the cohort up to 10 years. CHAIN is supported by the PII of COPD SEPAR

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 35 years.
* Diagnosis of COPD (GOLD PBD FEV1/FVC ratio \<0.70).
* Being in a stable phase of disease (8 weeks without exacerbation).
* Cummulative smoking ≥ 10 pack-years.
* Absence of asthma or other chronic respiratory disease that justify the ventilatory disorder (although a history of asthma is not an exclusion criteria);
* Absence of malignancy or very serious comorbidities that would prevent study completion.

Exclusion Criteria:

* Patients \<35 years.
* Recent exacerbation (\<8 weeks).
* Not giving written informed consent.
* Presence of asthma or other chronic respiratory disease justifying the ventilatory disorder,
* Diffuse bronchiectasis not associated with COPD.
* Presence of malignancy or very serious comorbidities that would prevent study completion.
* Difficulty to perform appropriate follow-up.