cyrilzakka/clinical-trials huggingface dataset:
E-nose Utility in the Diagnosis of Bacterial Infection in COPD

Hypothesis: A commercial e-nose (Cyranose 320) is able to detect specific breathprints from patients with COPD and bacterial infection

Thirty to 50% of COPD patients have airway colonization with potentially pathogenic bacteria. This is associated with worse prognosis. Currently, diagnosis of bacterial colonization relies mainly upon quantitative sputum culture. However, this method lacks good sensitivity. The electronic nose is a novel device made up of nanosensors capable of detecting specific volatile organic compounds (VOCs). OBJECTIVES: Main 1) To assess the usefulness of the electronic nose in the diagnosis of bacterial colonization in COPD. Secondary 1) To define the VOCs pattern associated with bacterial colonization. 2) To study the pattern of pulmonary and systemic inflammation associated with bacterial colonization as well its relationship with the aforementioned VOCs patterns.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients

Exclusion Criteria:

* Exacerbation in the last 4 weeks
Quality Control and Evaluation in Standard COPD Management

There is lack of quality control and evaluation indexes for standard COPD management in hospitals in China, leading to nonstandard in COPD management and discrepancy in therapeutic efficiency. This study focuses on establishing quality control and evaluation indexes for standard COPD management in hospitals in China, and evaluating the therapeutic efficiency after standard COPD management. This part is a prospective cohort which lasts 2 years. After standard COPD management according to GOLD 2017 by doctors in hospitals in China, patients will be followed up for their outcome after 1 year. Several indexes will be selected to evaluate the quality control of standard COPD management and its efficiency. The controls are from hospital-based subjects with a retrospective cohort study.


Eligibility Criteria:
Inclusion Criteria:

* 1.Clinical manifestation of COPD; post bronchodilator FEV1/FVC\<0.70

Exclusion Criteria:

* 1. lung cancer. 2. Any history of psychiatric disorders. 3.HIV positive. 4.Breastfeeding, pregnancy or planning to be pregnant. 5.Estimated lifetime less than 1 years due to underlying diseases.
Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Eligibility Criteria:
Inclusion criteria:

1. Diabetes type 2, detectable C-peptide, HbA1c 7-10%
2. Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age \> 18 years, BMI \<= 45 kg/m2

Exclusion criteria:

1. Uncontrolled hyperglycemia during Run-in
2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
3. Liver impairment; gastric surgery; medical history of cancer in last 5 years
4. Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
5. Unsufficient birth control, pregnancy and nursing
Efficacy and Safety of SHR3824 in Combination With Metformin in Subjects With Type 2 Diabetes

The purpose of this study is to obtain information on efficacy and safety of SHR3824 with metformin over 24 weeks and 52 weeks in metformin monotherapy poorly glycemic controlled chinese Type 2 Diabetes. Efficacy and safety will be evaluated by comparing the effect of SHR3824 with metformin to placebo with metformin when given in oral doses.

A phase III clinical study on efficacy and safety of SHR3824 combined with metformin for type 2 diabetes with poor glucose control in metformin monotherapy (multicenter, randomized, double-blind, placebo-parallel control). The 450 subjects received at least eight weeks of metformin monotherapy at a steady dose of 1500 mg or more before screening.

Evaluation of efficacy: compared with the group of placebo combined with metformin, HbA1c, fasting plasma glucose, postprandial plasma glucose, fasting body weight and blood pressure changes in the SHR3824 with metformin group

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of type 2 diabetes mellitus;
* Patients with type 2 diabetes mellitus treated with metformin monotherapy for ≥ 8 weeks and poor glycemic control, metformin dose stabilized ≥1500mg / day;
* FPG\<=15mmol/L;
* Hemoglobin A1c levels \>=7.0% and \<=10.5%;
* Body mass index (BMI) 19 to 35 kg/m2;

Exclusion Criteria:

* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
* Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
* Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
* History of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
* Past or current history of malignant tumor;
* Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
* Pregnant women, lactating mothers, or women of childbearing potential;
* Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
Effect of Banaba (Lagerstroemia Speciosa) on Metabolic Syndrome, Insulin Secretion and Insulin Sensitivity

The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.

Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin secretion.

The investigators hypothesis was that the the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, and lipid profile were evaluated after a 75 g of dextrose load.

12 received Banaba, 500 mg, two times per day (1000 mg) before meals during 3 months.

The remaining 12 patients received placebo with the same prescription.

Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.

Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients both sexes,
* Age between 30 and 60 years,
* Metabolic Syndrome according to the IDF criteria
* Waist circumference
* Man ≥90 cm
* Woman ≥80 cm

And two of the following criteria:

* High density lipoprotein
* Man ≤40 mg/dL
* Woman ≤50 mg/dL
* Fasting glucose ≥100 mg/dL
* Triglycerides ≥150 mg/dL
* Blood pressure ≥130/85 mmHg
* Informed consent signed

Exclusion Criteria:

* Women with confirmed or suspected pregnancy
* Women under lactation and/or puerperium
* Hypersensibility to resveratrol
* Physical impossibility for taking pills
* Known uncontrolled renal, hepatic, heart or thyroid diseased
* Previous treatment for the metabolic syndrome components
* Body Mass Index ≥39.9 kg/m2
* Fasting glucose ≥126 mg/dL
* Triglycerides ≥500 mg/dL
* Total cholesterol ≥240 mg/dL
* Low density lipoprotein (c-LDL) ≥190 mg/dL
* Blood Pressure ≥140/90 mmHg
Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus

The aim of the current study is to evaluate the safety and efficacy of Montelukast in treatment of obese patients with type 2 diabetes (T2DM).


Eligibility Criteria:
Inclusion Criteria:

- type 2 diabetic patients who had body mass index (BMI) ≥ 30 kg/m2 , were treated with metformin alone and had ages ranging from 18 to 60 years.

Exclusion Criteria:

* patients who had any other inflammatory disease
* patients with cardiovascular,
* patients with asthma
* patients with severe hepatic
* patients with renal disease,
* patients with epilepsy
* pregnant or lactating females.
Heat Therapy to Reduce Pain and Improve Walking Tolerance

The purpose of this study is to investigate whether exposure to heat therapy improves calf muscle oxygenation and enhances walking tolerance in patients with symptomatic Peripheral Arterial Disease (PAD).

Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance vascular function of the leg in old individuals. The objective of this study is to establish evidence to support the validity of HT in improving walking tolerance on PAD patents.

Subjects will complete baseline assessments for eligibility, including medical history and ankle-brachial measurement. Eligible participants will be asked to report to the laboratory on 4 different occasions. The purpose of visits 1 and 2 The central hypothesis of this study, based on preliminary data, is that exposure to HT will enhance the oxygenation of calf muscles during exercise and as a result, the onset of pain will be delayed and walking performance will be enhanced. is to familiarize the participants with the treadmill walking test and assess the test-retest reliability of maximal walking time determination. On visits 3 and 4 participants will receive either heat treatment or a control treatment for 80 min prior to undergoing a symptom-limited incremental test on the treadmill.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with stable symptomatic leg claudication for 6 months or longer.
* Ankle brachial index \< 0.9

Exclusion Criteria:

* Heart Failure
* COPD
* Critical limb ischemia
* Prior amputation
* Exercise-limiting co-morbidity
* Recent infrainguinal revascularization or planned during study period
* Plans to change medical therapy during duration of the study
* Active cancer
* Chronic kidney disease
* HIV positive, active HBV or HCV disease
* Presence of any unsuitable comorbid clinical condition in the opinion of the PI
* Peripheral neuropathy, numbness or paresthesia in the legs
* Morbid obesity, BMI \> 36 or unable to fit in water-circulating pants
* Open wounds or ulcers on the extremity
* Unable to walk on the treadmill
Tobacco Cessation Texting Intervention for People Living With HIV Who Smoke in Vietnam

The intersection of smoking and HIV/AIDS poses a serious public health threat in Vietnam. Vietnam is dealing with these two challenges with parallel rather than integrated plans. Using a computer-tailored texting intervention, study investigators seek to promote the use of an underused, available, government-funded resource (the Quitline) and Nicotine Replacement Therapy (NRT) that the quitline provides, thus, promoting cessation among PLWH.

M2Q2-HIV \[mHealth Messaging to Motivate Quitline Use and Quitting among Persons Living with HIV (PLWH) in Vietnam (M2Q2-HIV)\] is an adaptation of a current computer-tailored smoking cessation intervention in Vietnam. Study investigators seek to promote underused government resources for public health (the Quitline) and Nicotine Replacement Therapy (NRT) among PLWH in a sustainable manner.

Investigators will test M2Q2-HIV by conducting a randomized control trial with 600 PLWH smokers in two provinces in Northern Vietnam (26 clinics; 9,877 HIV patients).

In Aim 1, study investigators will conduct formative work to prepare the M2Q2-HIV system for PLWH smokers.

In Aim 2, the study team will randomize and follow smokers for six months. The study's effectiveness hypothesis will evaluate carbon monoxide (CO) verified, six-month, seven-day point prevalence cessation. Process hypotheses will evaluate self-efficacy, Quitline, and NRT use and test our hypothesized model that specific measured processes will partially mediate observed intervention effectiveness.

Using qualitative interviews with key stakeholders and PLWH smokers, Aim 3 will support nationwide M2Q2-HIV dissemination assessing acceptability and contextual factors guided by the Practical, Robust Implementation and Sustainability Model (PRISM).

This project builds upon a long-standing, successful collaboration between institutions in Vietnam (Ministry of Health, Bach Mai Quitline, Institute of Population Health and Development, Hanoi Medical University) and UMass Chan Medical School. The study team has expertise in smoking cessation, HIV intervention, including stigma related to concomitant substance use, and implementation of complex interventions. If proven effective, the Vietnam Ministry of Health is committed to incorporating M2Q2-HIV as a permanent part of the national infrastructure.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed HIV infection (prevalent and incident HIV).
2. At least 18 years old.
3. Current smoker.
4. Be able to receive texts and read text (literate).

Exclusion Criteria:

1. Pregnant or planning to become pregnant during the next six months.
2. Unable or unwilling to provide informed consent.
3. Prior diagnosis of serious mental health illness.
4. Smoker who helped develop the motivational texts used in the intervention (participated in Aim 1).
5. Family member of another participant in the study.
The Effect of Foot Massage on Blood Pressure and Anxiety Levels in Pregnants With Hypertension

This research was conducted as a prospective, experimental and randomised controlled research to determine the effect of foot massage applied to pregnant women with hypertension on blood pressure and anxiety levels.

The sample of the research a total of 80 pregnants, 40 interventions and 40 in the control groups, which were randomly selected from hypertension pregnant women who applied to Health Sciences University Istanbul Bakırköy Doctor Sadi Konuk Training and Research Hospital (BEAH). After the participants were given written and verbal information about the research, the intervention group received a foot massage for three days, 15 minutes on each foot, for a total of 30 minutes, while the control group did not receive foot massage. In the research; Participant Promotion Form which contains questions about general health appearances and socio-demographic, gynecological and obstetric story, Vital Finding Monitoring Form to save blood pressure, pulse and breathing numbers restrained before and after foot massage, State and Trade Anxiety Inventory (STAI) which evaluates the level of anxiety, was used.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18 years and over and diagnosed with hypertension during or before pregnancy were included in the study.

Exclusion Criteria:

* Pregnant women who could not communicate in Turkish were excluded from the study.
Stone Access and Removal (STAR) Study

The purpose of the study is to assess procedural completion, the post-operative stone clearance and the safety profile following robotic mini-Percutaneous Nephrolithotomy (PCNL) performed with the MONARCH Platform, Urology.


Eligibility Criteria:
Inclusion Criteria:

* Simple renal caliceal and/or pyelo stone(s) with stone burden =\> 1 cm, identified on CT scan, and appropriate for PCNL treatment according to AUA guidelines
* Normal upper tract anatomy, amenable to PCNL and ureteroscopy
* Participants with a percutaneous tract length \< 15 cm as measured by the estimation of the skin to stone or skin to appropriate calyx for treatment through a CT scan
* Participant is an appropriate candidate for a mini-PCNL based on the clinical guidelines and investigator assessment.

Exclusion Criteria:

Pre-Procedure:Exclusion Criteria:

* Any medical or physical condition/limitation that would contra-indicate a conventional ureteroscopy or PCNL in the supine position (e.g., atypical interposition of visceral organs (bowel, spleen, or liver))
* Expected additional procedure, or participation in any clinical trial, from 30 days prior to the study procedure and throughout the duration of the study, which might impact this study's results
* A solitary functioning kidney
* Female participants who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
* Presence of ureteral impacted stones

Intra-Procedure Exclusion Criteria:

- Any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the participant's best interest.
Evaluating Neuromodulation Technologies in Early Recovery

The study is an open-label comparative effectiveness clinical trial evaluating the impact of three neuromodulation treatment devices to improve the mental health and sobriety status of recovering substance abuse patients. We intend to enroll 200 patients to give us a sufficient number of subjects for the planned comparisons. Following informed consent and baseline assessment, patients will be randomly assigned to receive either 1) 15 40-minute sessions of Nexalin Brain Stimulator, a cranial electrical stimulation (CES) device, once-per-day within a 3-week time-frame; 2) 30 20-minute sessions of the Fischer Wallace Stimulator, another CES device, twice-per-day within a 3-week time-frame; 3) 15 40-minute sessions of the DAVID Delight, an audio-visual stimulation device (AVS), once-per-day within a 3-week time-frame; OR 4) the control-group condition of 15 40-minute relaxation therapy sessions once-per-day within a 3-week time-frame. All subjects will then be reassessed at the end of the 3 weeks of treatment and again 1, 3, and 6 months later. In addition to the assigned treatments, all patients will also receive the standard array of services that are provided by Behavioral Health of the Palm Beaches (BHOPB) including as clinically appropriate, psychiatric medication management and Eye Movement Desensitization Response (EMDR) therapy. Patients diagnosed with Post Traumatic Stress Disorder (PTSD) are assessed to determine their suitability for EMDR and if suitable, will receive 2 or more EMDR sessions. Patients without PTSD do not receive EMDR therapy.


Eligibility Criteria:
Inclusion Criteria:

Adults between the ages of 18 and 75 in early recovery from a substance abuse disorder.

Exclusion Criteria:

The exclusion criteria are patients diagnosed with 1) an uncontrolled seizure disorder, 2) a psychotic disorder with currently active features (e.g., paranoia), 3) a dissociative identity disorder, 4) a manic episode within the past month, 5) patients with a pace-maker or implanted vagal nerve stimulator, patients prescribed Subocone, Subutext, \&/or any psychostimulant medication (e.g., Alderol, Concerta, Focalin, Metadate, Vyvance, etc.) since these medications interfere with the ability of these neuromodulation devices' ability to have the intended effect on patients, and 7) pregnant woman.
Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta

This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study.


Eligibility Criteria:
Inclusion Criteria:

* Have completed the core CZOL446H2202 study
* Males or females between 1-17 years of age

Exclusion Criteria:

* Deformity or abnormality which would prevent spine bone density from being done
* Any surgical bone-lengthening procedure
* Any kidney diseases or abnormalities
* Low calcium or vitamin D levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.
Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients

The survival of adult patients with standard-risk acute lymphoblastic leukemia(ALL) need to improve. We want to compare the efficacy of haplo-identical hematopoietic stem cell transplantation (HSCT) with chemotherapy for adult(age:18-39 years old) ALL patients in first phase of complete remission (CR1)

Although the high complete remission rate (80%-90%) can be achieved, the long-term survival rate of standard-risk adult patients with acute lymphoblastic leukemia(ALL) is only 25%-55% when they receive chemotherapy alone. The survival rate can be further improved uo to 50%-75% when they receive HLA-matched HSCT However, the chance of finding a HLA-matched donor is low, especially in China. Alternative donor such as halpo-identical related donor might be an choice.

Our retrospective analysis showed about 59% overall survival could be achieved when standard-risk adult ALL patients received halpo-identical HSCT.Therefore, we start this randomization controlled trial to compare the efficacy of haplo-identical HSCT with chemotherapy for adult(age:18-39 years old) ALL patients in CR1.

Eligibility Criteria:
Inclusion Criteria:

* acute lymphoblastic leukemia
* 18-39 years old
* in first complete remission -Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤2.5 times the institutional ULN -
* Adequate renal function defined as creatinine ≤3 times the institutional ULN
* No uncontrollable infection
* Performance Status(PS)score 0-2(WHO)
* Subjects able to provide written informed consent

Exclusion Criteria:

* having HLA-matched donor
* high-risk ALL: (1)Ph+ALL (2)Hypodiploidy (3)t(v;11q23) (4) complex karyotype（≥5 chromosome abnormalities）（5）high white blood cell (WBC) count (B-ALL≥30×109/L;T-ALL ≥100×109/L).
* pregnancy
* Loss of ability to freely provide consent due to psychiatric or physical illness
Clinical Profile of Parkinson's Disease in Patients With Hepatitis C Infection

There is association between Hepatitis C and Parkinson's Disease as shown from previous studies. The clinical profile and natural history is not fully studied yet. We aim at studying the clinical characteristics of Parkinson's Disease in patients with hepatitis C infection.


Eligibility Criteria:
Inclusion Criteria:

* Patient with history of Parkinson's Disease and Hepatitis C infection.

Exclusion Criteria:

* Advanced liver cirrhosis.
* Patients with hepatic failure.
* Symptoms of Parkinson's plus syndrome.