cyrilzakka/clinical-trials huggingface dataset:
Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population

This is a prospective, multicenter, parallel-group, participants- and assessors-blinded randomized trial aiming to evaluate the effectiveness and safety of acupuncture in improving glucose metabolism for overweight/obese Participants with IGT, in comparison with sham acupuncture.

The trial will be conducted at three hospitals in China. 196 eligible subjects will be randomly assigned (1:1) to the acupuncture or sham acupuncture group to receive either 30-session acupuncture/sham acupuncture treatment over 12 weeks based on lifestyle intervention and 24-week follow-up. The primary outcome is the change in the value of 2-hour blood glucose (2hPG) from baseline at the end of the 12-week treatment. Additionally, compliance, blinding, and safety will also be assessed. All statistical tests will be performed using a two-sided test, a p-value of less than 0.05 is considered significant.

Eligibility Criteria:
Inclusion Criteria:

1. those who meet the diagnostic criteria of overweight/obesity and IGT:

   ①IGT: fasting blood glucose (PG) is lower than 7.0mmol/L, and 2-hour blood glucose (2hPG) after oral 75g glucose tolerance test (OGTT) is between 7.8\~11.1mmol/L.

   ②overweight: 24.0 \< BMI ≤ 27.9, obesity: BMI ≥ 28.0, or BMI ≤24.0 but Waist Circumference ≥85 cm (male) /≥80 cm(female).
2. 18-60 years old;
3. those who can appropriately describe their wishes, voluntarily fill in the informed consent form and agree to participate in clinical trials.

Exclusion Criteria:

1. obesity secondary to heredity, drugs, and diseases;
2. those who have received weight-loss treatment including acupuncture and drugs in the past 3 months;
3. those who have taken drugs that have known effects on body weight or appetite in the past 3 months, such as corticosteroids, antidepressants, non-selective antihistamines in vivo, nicotine substitutes, etc;
4. IGT is caused by abnormal thyroid function, endocrine tumors, extensive liver damage;
5. abnormal glucose tolerance caused by thiazide diuretics, β-blockers, nicotinic acid drugs, quinolones, calcineurin inhibitors, interferon-alpha, etc;
6. received antidiabetic medicines in the past 3 months；
7. participants with serious primary diseases such as heart, lung, brain, liver, or hematopoietic system diseases, progressive malignant tumor, or other serious consumptive diseases;
8. Participants with cognitive impairment and severe mental illness;
9. participants with blood coagulation dysfunction, and scare of needles；
10. pregnant, breastfeeding, or planning to conceive within 37 weeks.
A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors

A study of sequential administration of oral sapacitabine and oral Seliciclib in patients with advanced solid tumors.

The primary objective of this study is to determine the maximum tolerated dose (MTD) or recommended phase II doses of sapacitabine and seliciclib administered sequentially or concomitantly. The secondary objectives are to evaluate antitumor activity of this sequential or concomitant treatment and to explore the pharmacodynamic effect of this treatment in skin and peripheral blood mononuclear cells.

Eligibility Criteria:
Inclusion Criteria:

* Incurable advanced solid tumors that are no longer responding to conventional therapy or for which no effective therapy exists; at the RD of Part 1, an extension cohort up to 20 patients with metastatic breast cancer who are known to be BRCA mutation carriers will be enrolled.
* Age 18 years or older
* ECOG 0-2
* Life expectancy ≥ 3 months
* Evaluable disease
* Adequate bone marrow function
* Adequate renal function
* Adequate liver function
* At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
* Able to swallow capsules
* At least 3 weeks from major surgery
* Agree to practice effective contraception
* Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

* Previously untreated CNS metastases or progressive CNS metastases
* Currently receiving radiotherapy, biological therapy, or any other investigational agents
* Uncontrolled intercurrent illness including
* Pregnant or lactating women
* Known to be HIV-positive
* A history of active hepatitis B and/or hepatitis C infection
Analysis of Oxidative Stress Biomarkers and Their Determinants in ART-experienced PLWH

The project aims to assess the level of oxidative stress biomarkers in HIV patients on effective antiretroviral treatment in correlation with other therapeutic, clinical, and viro- immunological parameters. The analysis aims to better characterize the patient on treatment through an innovative approach based on two specific tests for complementary assessment of total oxidant and anti-oxidant plasma capacity.


Eligibility Criteria:
Inclusion Criteria:

* ART-treated PLWH
* HIV-1 RNA\< 50 copies/mL
* Stable ART therapy (at least 48 weeks)
* Signature of informed consent for study participation

Exclusion Criteria:

* none
Relation of Glucose and Acute Pancreatitis

Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a systemic inflammatory response syndrome with significant morbidity and mortality in 20% of patients. Part of endocrine function of pancreas would be affected in AP. Stress hyperglycemia would explode at acute phase. So the investigators decide to follow up and observe 200 cases of patients with acute pancreatitis, determining of blood sugar, blood amylase, hemoglobin and glycosylated hemoglobin level. At last, using ROC curve method to identify the die cutting between blood glucose level and acute pancreatitis, and makes analysis of the diagnostic value.

Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a systemic inflammatory response syndrome with significant morbidity and mortality in 20% of patients. Part of endocrine function of pancreas would be affected in AP. Stress hyperglycemia would explode at acute phase. There are two reasons. One is because that sympathetic hyperactivity makes glucagon elevated. Secondary, microcirculation disorder makes pancreas edema, ischemia and necrosis, affecting secretion and excretion of insulin. In severe acute pancreatitis, there may be ketoacidosis. Many scoring systems for predicting prognosis of severe acute pancreatitis also contains glucose values, such as the Ranson scoring system and the Glascow scoring system. On the other hand, Type 2 diabetes has become a global pandemic disease. Most of patients of type 2 diabetes are obese, who easily complicated gallstone disease and hypertriglyceridemia. All of above could be the risk factors for acute pancreatitis. Our initial small sample research also suggests undiagnosed diabetes patients whose glucose value elevated is significantly worse than the known diabetic patients. Therefore, the investigators believe that glucose directly affects the prognosis of AP. So the investigators decide to follow up and observe 1000 cases of patients with acute pancreatitis, determining of blood sugar, blood amylase, hemoglobin and glycosylated hemoglobin level. At last, using ROC curve method to identify the die cutting between blood glucose level and acute pancreatitis, and makes analysis of the diagnostic value.

Eligibility Criteria:
Inclusion Criteria:

patients that newly diagnosed as acute pancreatitis.

Exclusion Criteria:

exclude other acute abdomen, such as peptic ulcer with perforation, mesenteric arterial embolism or ruptured ectopic pregnancy.
Improve Compliance in Automated Peritoneal Dialysis Machine With SHARESOURCE

This study is to investigate the non-compliance rate of patients undergoing automated peritoneal dialysis by using automated peritoneal dialysis with SHARESOURCE software, and to evaluate if telemonitoring can improve peritoneal dialysis compliance and outcomes in the observation period.

The non-compliance of patients receiving automated peritoneal dialysis (APD) is around 10-20%, and was believed to be under-estimated. Recently, a two-way telehealth system, SHARESOURCE software, provide practitioners real-time monitoring and recording of the therapy of APD.

By using this APD with SHARESOURCE software, we want to investigate the non-compliance rate of patients undergoing automated peritoneal dialysis, want to see if it can improve peritoneal dialysis compliance and outcomes in the observation period.

Eligibility Criteria:
Inclusion Criteria:

* stable received peritoneal dialysis for over 1 year. Use automated peritoneal dialysis machine regularly by him/herself.

Exclusion Criteria:

* Acute hospitalization events due to acute coronary syndrome, stroke, heart failure, liver cirrhosis, systemic infection in 1 month.
* Life expectancy \<1 year
* Peritoneal dialysis prescriptions will be scheduled or expected to change in 3 months
Pilot Study on Caffeine Efficiency in ADCY5-related Dyskinesia

Heterozygous mutations in the ADCY5 gene cause involuntary early-onset hyperkinetic movements. In addition, patients may have associated psychiatric disorders.There is currently no treatment. As the pathophysiology is linked to ADCY5 hyperactivity, the investigative team has treated patients with caffeine, an antagonist. The investigator wishes to interview patients on the effect of caffeine on their motor symptoms and their overall clinical condition, and on the possible existence of psychiatric comorbidities using phone questionnaires.

Heterozygous mutations in the ADCY5 gene cause involuntary early-onset hyperkinetic movements. The phenotype combines chorea, dystonia and / or myoclonus with frequent facial involvement, axial hypotonia, fluctuations and / or episodes of paroxysmal dyskinesia which can be nocturnal and / or painful.

Many treatments have been tried, with no obvious efficacy. Two patients from the same family (a father and daughter) told investigators that caffeine had a dramatic effect on their paroxysmal episodes. They said that taking coffee would prevent episodes and reduce their duration (efficacy estimated at 80%), an effect specific to caffeine since it was reproduced by the ingestion of caffeine citrate capsules. Very interestingly, there is a rationale underlying this phenomenon. Indeed, caffeine is an antagonist of the adenosine A2A receptors (A2AR), receptors which activate ADCY5 and which are localized preferentially in striatal neurons expressing dopamine D2 receptors. As caffeine is an A2AR antagonist, it likely inhibits ADCY5, and therefore induces clinical improvement in patients with hyperactivity of this protein.

In addition, the investigative team noted anxiety in some of its patients, and the question of the presence of psychiatric disorders in ADCY5 patients was recently raised in the literature.

The investigative team wishes to collect standardized preliminary data by questioning patients on the effect of caffeine on their motor symptoms and their overall clinical state, and on the possible existence of psychiatric comorbidities using structured questionnaires which will be carried out by phone.

Eligibility Criteria:
Inclusion Criteria:

* Proven genetic diagnosis of ADCY5-related dyskinesia
* Caffeine intake
* Non opposition by the patient or the legal representatives if the patient is a minor.

No Exclusion Criteria.
Isolated Pelvic and Limb Perfusion in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle

This study looks at isolated pelvic perfusion and limbs' girdle with 1 mg tumor necrosis factor alpha (TNFa) in the treatment of locally advanced sarcoma of the pelvis and limbs' girdle.


Eligibility Criteria:
Inclusion Criteria:

* Soft tissue or bone sarcomas locally advanced of the pelvis or limbs' girdle

Exclusion Criteria:

* Resectable tumor without mutilation
Factors Contributing To Cardiovascular Morbidity and Mortality in Patients With Gastrointestinal Bleeding

The rate of complication and death of patients with acute digestive tract bleeding is increased in the setting of acute coronary heart disease. The aim of the study is to establish the relative importance of the risk factors contributing to the death rate from acute digestive tract bleeding in patients admitted with acute coronary heart disease.

The rate of complication and death of patients with acute digestive tract bleeding is increased in the setting of acute coronary heart disease. The aim of the study is to establish the relative importance of the risk factors contributing to the death rate from acute digestive tract bleeding in patients admitted with acute coronary heart disease. This study will be conducted at MMC and involve collecting your clinical information from our medical records and computer systems. Approximately 200 adult patients with acute coronary heart disease and acute digestive tract bleeding admitted to MMC will be enrolled and followed up for 1 year after recruitment. We propose to develop criteria and a scoring system that will assist your doctors in caring for patients like you in the future.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with acute CS and acute GI bleeding
Nicotine Pharmacokinetic in Blood and Analysis of Exhaled Breath After E-cigarette Smoking.

Electronic or e-cigarettes are battery-powered devices that deliver vapor which may be inhaled in the manner tobacco is smoked. The e-liquid is usually a solution containing propylene glycol and/or vegetable glycerin, nicotine, and flavor concentrates, although some e-liquids also are sold as non-nicotine containing products. The long- and short-term public health consequences of e-cigarette use, including the effects of e-cigarettes on tobacco use behavior, are not well understood. However, the prevalence of e-cigarette use appears to be undergoing a rapid increase.

In this study the investigators propose to analyze nicotine pharmacokinetic in blood and to compare the exhaled breath before and after e-cigarette smoking. They want to obtain a pharmacokinetic model of this population for nicotine. And they want to identify if molecules contained in vapor are absorbed, metabolized or modified by the organism.


Eligibility Criteria:
Inclusion Criteria:

* Subject who has already used electronic cigarette
* Subject who has been using electronic cigarette for more than one month and/or Tobacco smoker (traditional cigarettes)
* Subject without history of chronic pathology
* Subject not taking long-term drug treatment
* Subject able to understand studie's aims and risk

Exclusion Criteria:

* Subject with a chronic respiratory pathology
* Subject suffering from a respiratory or acute otorhinolaryngology pathology in progress or recent
* Subject under alcohol withdrawal
* Subject with heavy drinking or daily use of illegal drugs
* Subject with epilepsy
* Subject having hypersensitivity to one of the compounds of the spraying liquid
* Subject with liver failure
* Subject with severe renal impairment (GFR \<60 ml / min)
* Subject with an allergy to the molecules contained in the e-liquid
* Subject suffering from claustrophobia
* Pregnancy or breastfeeding
Low Level Laser in Isolated Cleft Palate Repair Versus Surgical Correction Without LLL in Healing Process

Does the use of low level laser (LLL) after surgical correction of cleft palate improve healing and decrease incidence of oronasal fistula?

Primary objective:

To evaluate the effect of adjunctive use of LLL after surgical correction of cleft palate in improving healing among children with cleft palate Secondary objectives To evaluate the effect of adjunctive use of LLL after surgical correction of cleft palate in decreasing incidence of oronasal fistula after surgical repair among children with cleft palate Study group: Will use LLL after surgical correction of cleft palate at day of surgery, 1st day and 3rd day Control group: Surgical correction of cleft palate without Adjunctive use of LLL

Inclusion criteria:

1. Age: between 6 to 18 months of age
2. Patient has isolated cleft palate

Exclusion criteria:

1. Systemic disease
2. Hematological disorder Outcome: Outcome measure (s) (1ry, 2ry) 1ry: healing assessment 2ry: occurrence of oronasal fistula

Eligibility Criteria:
Inclusion Criteria:

1. Age: between 6 to 18 months of age
2. Patient has isolated cleft palate

Exclusion Criteria:

1. Systemic disease
2. Hematological disorder
Effects of a Large Increase in Dietary Fats and Cholesterol on HDL Composition and Function in Healthy Subjects

In this study the investigators aimed at measuring the effect of a two-week high-fat/high-cholesterol (HFHC) normocaloric diet on HDL particles biochemical composition and HDL function compared to a two-week low-fat/low-cholesterol (LFLC) normocaloric diet.

HDL particles can change their composition and function in response to a variety of pathological conditions and environmental stimuli. It has been previously shown that a western diet is able to drastically modify biochemical composition, anti-inflammatory and anti-oxidant properties of HDL in animals. In humans little is known on the role of diet on HDL function and composition.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 and ≤40 years of age
* Lean or overweight (BMI: 18 to 29,9 kg/m2)
* Normal liver and kidney function
* Normal thyroid function
* Stable weight in the last 3 months
* Read and understood the informed consent form and signed it voluntarily

Exclusion Criteria:

* Liver, heart, kidney, lung, infectious, neurological, psychiatric, endocrine, immunological or neoplastic diseases
* Chronic use of drugs or vitamin supplements
* Smoking
* Pregnancy or lactation
Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma

The aim of the trial is to improve disease control after an allogeneic stem cell transplantation (alloSCT) for relapsed or refractory classical Hodgkin lymphoma (rrHL, cHL) with consolidation therapy by Brentuximab Vedotin (BV) for up to one year.

The primary objective of the trial is to show efficacy of the experimental consolidative treatment strategy. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed/refractory cHL who receive an allogeneic stem cell transplantation
* Histologically proven cHL in the most recent tumor biopsy
* Absolute neutrophil count ≥ 500/mm³
* ECOG ≤2
* Age ≥ 18 years

Exclusion Criteria:

* Presence of nodular lymphocyte-predominant HL (NLPHL) or grey-zone lymphoma
* Progressive disease as last documented response prior to alloSCT
* Any peripheral neuropathy ≥ grade 2
* Any other serious disease or organ dysfunction which might impair protocol treatment
SLEEP AND OSA ON REPRODUCTIVE FUNCTION IN MEN

In view of the hormonal changes induced by both sleep deprivation and obstructive sleep apnea syndrome (OSA), and the importance of maintaining these hormones in reproductive processes. The present study aims to evaluate the effects of the OSA or sleep deprivation (total or selective REM sleep for 48h) on reproductive function in adult men with normal body mass index.

In this study will be recruited volunteers 25-50 years of age with a body mass index (BMI) 20-25 kg/m2 (normal) that after performing polysomnography, will be distributed in the following groups: healthy or diagnosed with obstructive sleep apnea syndrome (OSA). Volunteers without OSA will be submitted to total sleep deprivation (SD) or selective REM sleep deprivation for 48 hours. After SD, these volunteers will be allowed to sleep for 48 hours (period rebound). Blood samples will be taken for hormonal analysis (testosterone, luteinizing hormone, follicle-stimulating hormone, progesterone and cortisol)and gene expression. The semen collection for evaluation of sperm count (concentration, viability and sperm morphology) in three different periods, baseline collection, after SD protocols and the end of rebound period. Individuals diagnosed with OSA also have three collections of blood and semen samples for analyzes.

Eligibility Criteria:
Inclusion Criteria:

* men
* There is no discrimination of economic class
* Age between 25 and 50
* BMI 30 kg/m2
* No prior neurological, psychiatric or use of psychotropic medication
* OSA (moderate and severe apnea hypopnea index \> 15)

Exclusion Criteria:

* smokers
* addiction
* Individuals with another sleep disorder
* Severe uncontrolled organic disease that might interfere with the conduct of the study, such as cancer, heart disease, digestive disorders, diabetes mellitus, male reproductive system
* Presence of moderate or severe depression and psychiatric disorders
* Volunteers with previous treatment for OSA
Dextroamphetamine-Cocaine Behavioral Intervention - 5

The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in cocaine dependent patients.


Eligibility Criteria:
Please contact site for information.
COVID-19 Versus Neurological Impairment, Physical Activity, Social Contacts and Education

The research will make it possible to assess patients who recovered from COVID-19 for the incidence of neurological problems (impaired balance, gait, coordination, concentration and attention), and changes in the quality of life, physical activity, social contacts and education.

The intended size of group - 100 subjects (50 subjects - study group, 50 subjects - control group). The above population was determined based on sample size calculator, with the following parameters: fraction size of 0.9, Confidence Interval of 95%, maximum error of 9%. The proper study will be preceded with a pilot study involving a smaller group of subjects (in order to standardise the surveys, and minimise the relationship between the results of the survey and side-effect factors). After inclusion and exclusion criteria are considered, the subjects will be allocated into two groups:

* study group (subjects who had tested positive and recovered from COVID-19)
* control group (healthy subjects who did not have COVID-19). The controls will be matched to the study group for gender and age.

The examination will be performed once, at the premises of the University of Rzeszów. The participants' condition will be assessed using the following measures:

* static and dynamic balance and risk of falls (force plate and computerised posturography, clinical tests)
* activity in the cerebral cortex of the frontal lobe during focused performance of a task (Hemoencephalography HEG-System)
* concentration and attention, memory and cognitive functions (Bourdon-Wiersma test and Auditory-Verbal Learning Test)
* gait velocity and efficiency (10-meter walk test and 6-minute walk test)
* physical activity (International Physical Activity Questionnaire IPAQ), as well as education, mood, and social contacts (specially designed questionnaire)
* quality of life (SF-36 questionnaire)

Eligibility Criteria:
Inclusion Criteria:

* Informed consent to participate in the study.
* Experienced infection with SARS-COV-2.
* Age 19 - 26 years
* No injuries to lower limbs in the period of 12 months preceding the date of enrolment into the study
* No orthopaedic disorders affecting the lower limbs (including decreased length of the lower limbs)
* No diagnosed neurological diseases or disorders (including labyrinth dysfunction)
* No diagnosed impairment of concentration and attention

Exclusion Criteria:

* Lack of informed consent to participate in the study
* No experience of infection with SARS-COV-2
* Age outside the range of 19 and 27 years
* Confirmed injuries to lower limbs in the period of 12 months preceding the date of enrolment into the study
* Confirmed neurological diseases or disorders, such as impaired balance, concentration and attention.