cyrilzakka/clinical-trials huggingface dataset:
Surveillance and Medical Help for HIV-infected Intravenous Drug Users in and Out of Prison

It is difficult to detect the intestinal protozoal infections among the HIV-infected persons or travelers diarrhea by using the traditional microscopy or staining methods. The purpose of this study aimed at finding out the appropriate diagnostic methods and the infection rate of the intestinal protozoa, including the Entamoeba, Cryptosporidium and Giardia among the HIV-infected persons by using the antigen detection method and biological method. The investigators also tried to analyze the associated HIV infection status and sexual transmitted diseases (STD) including Gonorrhea, Chlamydial trachomatis, Syphilis, Genital warts and Herpes simplex virus in this study. The study will collect the blood, urine and stool samples from 200 intravenous drug user (IDU) with HIV-infected in the prisons, 400 intravenous drug user (IDU) without HIV infected and 100 intravenous drug user (IDU) with HIV infected receiving methadone maintenance treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HIV
* Receiving Methadone Maintenance Treatment
* intravenous drug user (IDU)
Assessment of Hepatitis B Virus Intra-host Population and Host-specific Immune Marker Diversity

In this project proposal, the investigators will investigate the genetic alterations of Hepatitis B Virus (HBV) strains circulating in Belgian patients who developed end stage liver disease. Additionally, the investigators will compare and link these data sets with three genetic factors involved in immune system response.

This project proposes to identify and characterize the genetic alterations associated with intra-host evolution of HBV from a chronically infection status to an end-stage liver disease status.

Eligibility Criteria:
Inclusion Criteria:

Study group:

* Clinical diagnosis of advanced liver disease related to chronic Hepatitis B infection (cirrhosis, hepatocellular carcinoma,..)
* Availability of serum samples

Control group:

* Clinical diagnosis of liver disease related to chronic Hepatitis B infection in a pre-advanced stage
* Matched demographic and geographic characteristics to study group
* Availability of serum samples

Exclusion Criteria:

* Liver disease caused by other hepato-tropic viruses
* Patients with auto-immune diseases
Effect of Transauricular Vagus Nerve Stimulation on Postoperative Pain Management in Video Assisted Thoracic Surgery

Transcutaneous auricular vagus nerve stimulation (taVNS) is a novel pain management technique that has gained popularity in recent years due to its non-invasive nature and ease of operation. Current literature has substantiated its efficacy in managing pain syndromes and chronic pain. However, there is a paucity of evidence regarding its effectiveness in treating acute postoperative pain. This project aims to explore the efficacy of taVNS in postoperative pain management, with a focus on video-assisted thoracic surgery(VATS). The investigators have designed a double-blind, single-center, randomized controlled clinical trial, planning to enroll 116 patients scheduled to undergo VATS(including segmentectomy or lobectomy) under general anesthesia at Peking Union Medical College Hospital. Participants will be divided into an intervention group (receiving taVNS) and a sham intervention group (receiving sham-taVNS), and will undergo a 2-hour intervention on the first postoperative day. The primary outcome is the pain relief rate, defined as a reduction of 15mm or 30% in the VAS (1-100mm) score immediately before and after the intervention on the first postoperative day. Secondary outcomes include: the proportion of patients with inadequate analgesia within three days after intervention; the difference in VAS scores immediately before and after the intervention on the first postoperative day; the incidence of opioid-related and taVNS-related side effects from the first to the third postoperative day after intervention; the number of effective and ineffective PCA presses (if used) from the first to the third postoperative day after intervention; the specifics and frequency of additional analgesic measures taken by patients from the first to the third postoperative day after intervention; the difference in RCSQ scores on the night of surgery and the night after intervention; and the probability of patients experiencing surgery-related pain three months after surgery. Follow-up period for this study will be three months after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older;
2. ASA classification I-III;
3. No prior taVNS treatment;
4. Scheduled to undergo VATS (including segmentectomy and lobectomy);
5. VAS ≥ 30 mm at any time on the day of surgery;
6. Patients and their families can understand the study design and are willing to cooperate and participate in the study.

Exclusion Criteria:

1. Psychiatric disorders or other conditions that prevent cooperation;
2. Long-term use of steroids or opioids;
3. Scheduled for bilateral VATS surgery;
4. History of thoracic surgery;
5. History of chronic pain, autoimmune diseases, or persistent infections.

Withdrawl Criteria:

1. Patient request;
2. Surgery cancellation or change in surgical method resulting in failure to meet inclusion criteria;
3. Severe perioperative complications and adverse events;
4. Severe intervention-related adverse events.
Study to Evaluate the Pharmacokinetics and Safety of Singulair and Xyzal in Free Combination and Fixed-dose Combination

The purpose of this study is to evaluate the pharmacokinetics and safety of Singulair (10 mg) and Xyzal (5 mg) in free combination and fixed-dose combination as HCP1102


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* Age between 20 and 55
* Signed informed consent

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypotension or hypertension
* Has a history of acute infection within 14 days of screening
Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.

A randomized single-blind study with the use of three lancing devices equipped with personal lancets. Every device will be studied for three lancet sizes: 28G, 30G, and 33G with the minimum and maximum puncture depth setting.


Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosed diabetes type 1 or 2 ,
* aged 18 - 50,
* period of suffering from diabetes \>2 years,
* performing on average 3-8 daily measurements of glycaemia,
* glycaemia at the moment of the beginning of the study between 70 and 200 mg/dl.

Exclusion Criteria:

* glycaemia below 70 mg/dl or glycaemia above 200 mg/dl at the moment of the beginning of the study,
* previously diagnosed hemorrhagic diathesis or heavy bleedings in the past (also those without a medical diagnosis),
* anticoagulant (thrombolytic medication) therapy within 3 weeks prior to the study or on the day of the study,
* non steroidal anti-inflammatory drugs (NSAID) treatment 1 week prior to the study or on the day of the study,
* patients with signs of dehydration,
* patients who are currently participating in another clinical study,
* currently diagnosed or reported by the patient skin diseases, nervous system diseases, psychiatric diseases, etc., which, in the opinion of the person conducting the study, disqualify the patient from the participation in the study, in care for the patient's well-being.
Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.

Metformin is a widely used anti-diabetic drug. Several studies have pointed out a potentially beneficial effect of metformin therapy in diabetic cancer patients. Several studies are investigating the anti-tumor effect of metformin in early breast cancer. However, the enhancing effect of metformin on anti-tumor immunity has only been demonstrated in animal models. This study examines the immune effect of metformin in breast cancer patients treated with preoperative chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven breast carcinoma.
* American Society of Anesthesiology (ASA) score I-II.
* Candidate for neoadjuvant chemotherapy as per hospital's protocol.
* Clinically measurable tumor.
* No evidence of distant metastasis.
* Normal renal and liver functions.
* Non-diabetics.

Exclusion Criteria:

* Pregnant or lactating women.
* Metastatic breast cancer patients.
* Patients with hepatic impairment.
* Patients with renal impairment.
* Diabetics.
* Patients unwilling to participate or withdrawing from the trial.
* Psychological/ mental impairment.
Wolf 24 F vs. Storz 28 F Laser Sheath Size for HoLEP

The purpose of this study is to compare two different types of scopes that can be used for HoLEP. HoLEP is performed through the urethra using a Laser scope to remove obstructing prostate tissue. Laser scopes come in different sizes (diameters).


Eligibility Criteria:
Inclusion Criteria:

* Patients Males 18-89 undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms

Exclusion Criteria:

* Patients who lack decisional capacity
Habits, Orthorexia Nervosa and LIfestyle in STudents

Non-communicable diseases (NCDs) compose a substantial proportion of the global burden of diseases, posing a significant challenge in both high-income and low- and middle-income countries. In particular, certain lifestyle-related risk factors, such as unhealthy diet, physical inactivity, smoking, excessive alcohol consumption, and sleep deprivation are the leading risk factors, which place people at an increased risk of developing NCDs. On the other hand, a growing phenomenon of excessive concern about diet and health is emerging, and it is contributing to the development of a novel eating behavior disorder named orthorexia nervosa. According to recent studies, orthorexic behavior is very common among young adults and especially so in health-care professionals.

The main objective of this multi-center study is to explore and compare lifestyle habits among undergraduate medical students and other healthcare-related professions from different countries (Croatia, Lebanon, Italy, Poland, Spain, and Turkey). The goal is to obtain information on the presence of unhealthy habits in order to be able to intervene, offering the information needed for primordial disease prevention in this young and still healthy group of respondents, who are the health educators and role models of the future. The particular importance of this goal is to raise awareness of the problem of the ubiquitously present unhealthy lifestyles. Unfortunately, health-care students are not the exception regarding the prevalence of the unhealthy diet, sedentary behavior, sleep deprivation and high levels of psychological stress. Furthermore, the adoption of unhealthy lifestyle patterns in health-care workers, such as doctors and nurses, will have far-reaching negative consequences, in both their health and their patients' health. The results of this study will be used for identifying the needs and targets for intervention, enabling students to become a pillar of health education for their patients and the population in general.


Eligibility Criteria:
Inclusion Criteria:

1. students enrolled in any of the health-care related studies:

   * medical students
   * dental medicine students
   * pharmacy students
   * nursing students
   * physiotherapy students
   * dietetics/nutrition students
   * biomolecular science students
   * biomedical laboratory techniques students
   * psychology students
2. economy students
3. students of maritime sciences

Exclusion Criteria:

* none
Comparison Between Two Surgical Methods for Eyelid Ectropion: Tarsal Strip Alone Versus Tarsal Strip With Punctoplasty (Three Snips With or Without Diamond-shaped Resection)

Ectropion of the eyelid can lead to skin retraction, stenosis of lacrimal point, chronic watering, visual discomfort or low visual acuity, mostly when it occurs with ectropion of lacrimal point. The objective of the study is to compare two surgical strategies for eyelid ectropion combined with ectropion of the lacrimal point

Were included patients underwent eyelid ectropion surgery in ophthalmology department from Oct 2014 to Oct 2015. The first procedure is lateral tarsal strip alone (group 1); the second one is lateral tarsal strip with three snips with or without diamond-shaped resection (group 2). The authors focused on the alteration of the quality of life related to watering, before and after operation. Quality of life related to discomfort due to watering was evaluated before and after surgery using a questionnaire. Informations have been gathered via phone with a ten items questionnaire, each item is worth 0 (no or minim discomfort due to watering) or 1 (discomfort due to more than moderated watering)

Eligibility Criteria:
Inclusion Criteria:

* patients underwent eyelid ectropion surgery

Exclusion Criteria:

-
Therapeutic Management and Use of Resources and Costs of Spinal Muscular Atrophy in Spain

An observational, retrospective, cross-sectional, multicenter study. Real-world data were obtained from medical records of Spanish public hospitals (9 hospitals).


Eligibility Criteria:
Inclusion criteria:

* Patients diagnosed with SMA type I or SMA type II.
* Patients with medical records available in the hospital.
* Patients diagnosed with SMA type I or SMA type II after 2017 for whom a minimum of 6 months of follow-up was available.

Exclusion criteria:

• Patients who participated in an experimental design study except for those in the long-term follow-up period, during the observation period.
Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome

Polycystic ovarian syndrome (PCOS) is the most common cause of anovulatory infertility and causes menstrual disruption in 6.6-6.8% of women in reproductive age and is characterized by insulin resistance, hyperinsulinemia, hyperandrogenism and anovulation. The gaol of this study was to assess the effects of metformin on menstrual disorders and lipid profile in women with PCOS in bandarabbas.

Poly cystic ovarian syndrome (PCOS) is a common hormonal disorder in women that affecting of 6.6-6.8% of women o f reproductive age. PCOS associated with a broad range of clinical, hormonal and metabolic disorders consist of hirsutism, Obesity, Acne and elevated male hormones, anovulatory cycles, dyslipidemia and infertility.

Metformin is an oral hyperglycemic agent witch by decrease insulin resistance and improving serum glucose level in diabetic patients and anovulatory cyle in women with PCOS. The goal of this study is to evaluate the efficacy of different dosage of metformin on menstruation and lipid profile in women with PCOS in banda-abbas.

Eligibility Criteria:
Inclusion Criteria:

* Women with PCOS

Exclusion Criteria:

* avoiding to participate in the study
Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)

The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of valaciclovir in pediatric patients with chickenpox


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with chickenpox (aged less than 15 years old).

Exclusion Criteria:

* Patients with a history of hypersensitivity to the ingredients of valaciclovir or acyclovir.
Comparison of Different Volume of Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

This study was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis

adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (10cc steroid hydrodilatation under ultrasonographic guidance ) and group 2 (20cc steroid hydrodilatation). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Shoulder Pain And Disability Index

Eligibility Criteria:
Inclusion Criteria:

1) age 35-65 years (to prevent the inclusion of patients with secondary AC), 2) onset of shoulder stiffness since over a month, and 3) limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation.

Exclusion Criteria:

1. ultrasound findings of rotator cuff tears, 2) plain radiography findings of significant glenohumeral joint arthritis, 3) accompanying cervical radiculopathy, 4) systemic inflammatory joint disease, 5) intraarticular injection into the glenohumeral joint within the past 3 months, 6) history of surgery on the affected shoulders, 7) regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids, and 8) allergy to corticosteroid or lidocaine.
Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism

There are two phases to the study. The first will examine serum copper and zinc levels and copper/zinc ratio in children (ages 3-8) who have autism and compare them to levels from same sex and age children who are developing typically. The hypothesis is that there is a significant difference in the copper/zinc ratio between young children who have autism and their typically developing peers.

The second phase of the study will evaluate the effect of dietary supplementation using zinc and vitamin C for 16 weeks on selected symptoms of autism. Children with autism will be enrolled on the basis of copper/zinc ratios greater than 2.0, and as determined to be statistically higher than typically developing children. Measurements of serum copper, zinc and unbound copper will be obtained prior to, at the mid-point and end of the trial. Those children whose ratios have not fallen below 1.25, the top of the currently recognized range will have the zinc and vitamin C doses adjusted for the duration of the trial. Detailed evaluation of language skills, and a variety of behaviors will be evaluated prior to and after supplementation. The study will be placebo-controlled and double blind. Those children enrolled in the placebo arm will be offered a full trial of supplements at the end of the their participation in the study.

The hypothesis to be tested is whether correction of elevated copper to zinc ratios in children with autism can be accomplished by oral supplementation with zinc and vitamin C and if these children show measurable and significant changes in receptive or expressive language or behavioral parameters associated with autism.


Eligibility Criteria:
Inclusion Criteria:

* Ages 3-8 years
* Diagnosis of autism spectrum disorder
* Serum copper/zinc ratio greater than 2.0 or as determined in phase 1 of the study

Exclusion Criteria:

* Known chromosomal disorder or neurological disorders other than autism
Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy

The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin


Eligibility Criteria:
Inclusion Criteria:

* Patients chronically infected with HCV Genotype-1b
* Naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined based upon local guidelines)
* HCV RNA viral load ≥100,000 IU/mL at screening
* Patients with compensated cirrhosis are permitted

Exclusion Criteria:

* Infection with Hepatitis C virus (HCV) other than Genotype-1b
* Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)-1/HIV-2 antibody test at screening
* Evidence of chronic liver disease caused by diseases other than chronic HCV infection
* Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
* Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
* Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
* Laboratory values:

  1. Hemoglobin \<12.0 g/dL (males) or \<11.0 g/dL (females)
  2. Platelets \<90,000/mm3
  3. Total serum bilirubin ≥2 mg/dL (unless due to Gilbert's disease)
Ex-Vivo Lung Reconditioning

Only about 15% of the potential candidates for lung donation are considered suitable for transplantation. Thus, a strategy that could improve the quality and precision of assessment of nonacceptable donor lungs could have a major impact on reducing waiting time and mortality while on the list.

A new method for ex vivo lung perfusion (EVLP) has been developed recently by Steen and colleagues to assess the quality of lungs from a non-heart-beating donor. The method can also be used to recondition "marginal" and nonacceptable donor lungs.

After harvesting, the lungs were perfused ex vivo with Steen Solution, an extracellular matrix with high colloid osmotic pressure. A membrane oxygenator connected to the circuit received gas from a mixture of nitrogen and carbon dioxide, maintaining a normal mixed venous blood gas level in the perfusate. The lungs were gradually rewarmed, reperfused, and ventilated for evaluation through analyses of oxygenation capacity, pulmonary vascular resistance (PVR), lung compliance (LC), and biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients on the waiting list for lung transplantation and for which the Biomedicine -Agency has awarded a lung transplantation after Ex-Vivo lung reconditioning
* Patients affiliated to a social security system;
* Patients who consented to participate in writing

Exclusion Criteria:

-Patients under tutorship or unable to consent or institutionalized
Regional Anesthesia and Partial Mastectomy

Pectoralis nerves plane block (PECS) first described by Blanco in 2011 has become part of postoperative pain management in breast surgery, thoracic surgery and thoracic trauma. The combination of low complication risk and easiness in mastering of PECS block has made it an interesting alternative to thoracic epidural anesthesia (TEDA) and paravertebral blockade (PVB) for pain treatment after breast surgery. Several studies showed good results when PECS was compared to PVB. PECS blockade however is a procedure requiring some resources in the operating room. An alternative approach is to inject local anesthetics (LA) in the operation field by the surgeon.

The hypothesis' tested in this study is primarily: that PECS blockade is superior to LA being injected by surgeon in the operating field measured by end points such as: post-operative pain, post-operative analgesics use, post-operative nausea or vomiting (PONV) and length of stay in the post anesthesia care unit (PACU).


Eligibility Criteria:
Inclusion Criteria:

* Women scheduled for partial mastectomy (lumpectomy).

Exclusion Criteria:

* Scheduled cryosection
* Axillary node dissection
* Re-resection
* Age under 18 or unable to give an informed concent
* Chronic pain history
* Allergy to local anesthetics
* History of active drug addiction
* Pregnancy