cyrilzakka/clinical-trials huggingface dataset:
Pilot Study to Detect Zika Virus in Sperm

The purpose of this study is to seek the presence of ZIKV in semen, to determine its localization and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.

Since the end of 2015 an epidemic of ZIKA virus (ZIKV) infections is occurring in the Antilles-Guyana departments and focuses our attention on ZIKV and the risk of transmission during assisted reproductive technologies (ART). The importance of this epidemic and the presence in mainland of its mosquito vector (Aedes albopictus) point out the risk of a geographic extension of this infection. In this context the use of Medically Assisted Procreation leads to several questions when patients are infected. The question surges for patients (women and men) who live in epidemic areas but also for people who return from these regions and many other countries within the epidemic area (principally south and central America) and who need ART. Information about localization of ZIKV in the genital tract or shedding is poorly documented. Only two case reports detected ZIKV RNA in the semen and a sexual transmission was described. However, there is no data on the duration of the presence of ZIKV in semen and on localization of ZIKV in semen compartments (cells, seminal plasma, spermatozoa). The purpose of this study is to seek the presence of ZIKV in semen, to determine its localization and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.

This is a prospective study involving 15 patients, with acute ZIKV infection and a positive RNA detection in blood or/and urines (Institut Pasteur, Pointe-à-Pitre). Men will give semen, urine and blood specimens 7 days after the beginning of clinical signs and 11, 20, 30, 60 and 90 days after. ZIKV RNA being diagnosed with blood and/or urine sample positive for ZIKV RNA. ZIKV RNA will be detected in seminal plasma, native semen cells and processed spermatozoa. Semen sampling and processing will be performed within the ART laboratory of the hospital of Pointe-à-Pitre (Guadeloupe) and research of ZIKV RNA in the laboratory of Virology of Toulouse University Hospital. This study will identify the presence or absence of ZIKV seminal shedding and in case of shedding, verify the efficiency of semen processing to obtain virus free spermatozoa.

These results are important to understand the physiopathology of ZIKV infection and will help to define the management and viral safety procedures during Medically assisted Procreation in the context of ZIKV epidemic.

Eligibility Criteria:
Inclusion Criteria:

* infection by ZIKA virus in early stage

Exclusion Criteria:

* non infected male,
* erection problems
A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe

Open-label study of a regimen of antiretrovirals for the treatment of AIDS-KS. This study will be conducted at a single site, the Parirenyatwa Hospital KS Clinic.

Step 1 was conducted to determine the extent of clinical resolution of AIDS-KS disease in response to treatment with antiretroviral therapy and to investigate whether clinical resolution of KS is associated with suppression of KSHV replication.

Step 2 was developed to then evaluate the clinical, immunological, and virological effects of a switch from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease inhibitor in persons with AIDS-KS and good virologic suppression an all NRTI regimen.

Step 3 was included to evaluate the clinical, immunological, and virological effects of intensification with a ritonavir-boosted protease inhibitor in persons with AIDS-KS who have virological failure on an all NRTI regimen.

To identify factors associated with successful treatment of KS with antiretroviral therapy and to determine if highly active antiretroviral therapy improves survival and quality of life for persons with AIDS-KS in Zimbabwe.

A secondary objective is to investigate the durability of HIV-1 suppression by the combination of ABC/3TC/ZDV in persons infected with HIV-1 subtype C and to evaluate the timing and characteristics of mutations in HIV-1 reverse transcriptase in subjects who fail to achieve, or to maintain suppression of HIV-1 replication during treatment with ABC/3TC/ZDV.

An important objective is to assess adherence to a simplified antiretroviral regimen in a resource-limited setting.

The study will evaluate the clinical, immunological, and virological effects of a switch from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease inhibitor in persons with AIDS-KS and good virologic suppression on ABC/3TC/ZDV (see above).

Eligibility Criteria:
Inclusion Criteria:Completion of at least 96 weeks of treatment with ABC/3TC/ZDV on protocol Step 1.

* Currently receiving ABC/3TC/ZDV on Step 1/initial open-label allNRTI phase of study.
* Plasma HIV-1 RNA \< 400 copies/mL on the most recent plasma HIV-1 RNA performed within 4 weeks of Step 2 entry.
* Willing to potentially switch to a new antiretroviral regimen.
* In the opinion of the site investigator currently has clinical evidence of active KS disease.

Exclusion Criteria

* None
Comparison of Curative Effect Between New Tension Band and Patellar Tension Reduction Band in the Treatment of Lower Pole Fractures of Patella

Research purposes:

Analyze the curative effect of the new tension band system composed of φ3.0mm hollow nails, titanium cables and new gaskets and the patellar tension reduction band in the treatment of lower pole fractures of the patella.

research method: A retrospective study of 41 cases of comminuted fractures of the lower pole of the patella treated with a new tension band system composed of φ3.0mm hollow nails, titanium cables and new spacers from March 2012 to July 2017, including 19 males and 22 females , The average age is 56.7 years (22 to 79 years), 24 cases of AO/OTA A1 type, and 17 cases of C1.3 type. During the same period, 22 cases of comminuted fractures of the lower pole of the patella were treated with a patella tension band, including 8 males and 14 females, with an average age of 57.4 years (32 to 84 years), 17 cases of AO/OTA type A1, and 5 cases of type C1.3. The injury mechanism is all slipping and kneeling injuries.

Research purposes:

Analyze the curative effect of the new tension band system composed of φ3.0mm hollow nails, titanium cables and new gaskets and the patellar tension reduction band in the treatment of lower pole fractures of the patella.

research method: A retrospective study of 41 cases of comminuted fractures of the lower pole of the patella treated with a new tension band system composed of φ3.0mm hollow nails, titanium cables and new spacers from March 2012 to July 2017, including 19 males and 22 females , The average age is 56.7 years (22 to 79 years), 24 cases of AO/OTA A1 type, and 17 cases of C1.3 type. During the same period, 22 cases of comminuted fractures of the lower pole of the patella were treated with a patella tension band, including 8 males and 14 females, with an average age of 57.4 years (32 to 84 years), 17 cases of AO/OTA type A1, and 5 cases of type C1.3. The injury mechanism is all slipping and kneeling injuries.

Eligibility Criteria:
Inclusion Criteria:Patients with comminuted fractures of the lower pole of the patella: AO/OTA type A1 and C1.3 type -

Exclusion Criteria:1. Except for other types of patella fractures 2. Except for open patella fractures 3. Excluding patients with other fractures and injuries 4. Exclude patients who cannot cooperate with functional exercises

-
Effect of Pursed Lips Breathing on Chest Wall, Mobility Diaphragmatic and Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease

This study aimed to evaluate the acute effect of PLB technique on diaphragmatic mobility, the kinematics of the thoracoabdominal complex analysis of lung volumes and exercise tolerance in patients with Chronic Obstructive Pulmonary Disease (COPD). This is a study randomized cross-over clinical trial and blind, in subjects with Chronic Obstructive Pulmonary Disease (COPD) according to criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) (FEV1 / FVC \<0.7 and FEV1 \<80% predicted) selected at the Clinical Hospital of the Federal University of Pernambuco (UFPE) and Otavio de Freitas General Hospital (HGOF). The investigators recruited 13 patients COPD (according to previous sample calculation) aged between 40 and 80 years, of both sexes. The first day was held evaluation of lung function, respiratory muscle strength, body composition, dyspnea index and functional capacity. On the second day was held evaluation of thoracoabdominal complex kinematics by plethysmography Optoelectronics (OEP) with Quiet Breathing (QB) or pursed-lips breathing (PLB). Lung volumes with 2 minutes with QB and 6 minutes PLB or only 6 minutes by QB as randomization were observed. Before and after performing the requested breathing pattern diaphragmatic mobility was observed by Ultrasonography (US) and requested the patient an Inspiratory Capacity maneuver (IC). The evaluator who performed the ultrasound was blinded as to the beginning of the breathing pattern of order performed by the patient.


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis with stage II-IV (GOLD),
* Stable clinical condition (no exacerbation or hospital admission in the last four weeks preceding the study)
* Absence of other disease that may potentially contribute to dyspnea (heart disease, congestive heart failure, neuromuscular diseases, severe postural changes)

Exclusion Criteria:

* BMI\> 30 kg / m2
* Musculoskeletal limitations
* Use of oxygen therapy
* Extreme discomfort during the procedure application
Diet With or Without Metarecod® in Obese Subjects With Type 2 Diabetes

Obesity is considered the largest chronic non-communicable disease (globesity) worldwide with a growing trend in the near future. Weight loss programs are strongly recommended in obese patients, especially with type 1 diabetes mellitus (T2DM), although the majority of subjects do not reach or maintain the recommended weight loss target with nutritional intervention alone and one-third of those who achieve a significant weight loss returns to original body weight within one year. Metarecod® (Neopolicaptil Gel Retard) is a substance based medical device consisting of a macromolecule complex derived from high-fiber raw materials, whose mode of action consists in creating an endoluminal gel in the gut that limits glucose and lipids absorption. The primary aim of the present study is to assess whether the combination of Metarecod® and standard diet as compared to diet alone can achieve a superior weight loss over 12 months of treatment. The present study will also compare the effects of the combination of Metarecod® and diet vs diet alone on:

1. the improvement of glycemic variability and metabolic indexes;
2. the oxidative status, the endothelial anti-thrombotic activity, the inflammatory status;
3. the induction of favorable changes in gut microbiota composition and intestinal permeability.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed consent at study entry;
2. Age: 30-70 years;
3. T2DM diagnosis according to the American Diabetes Association criteria since ≥6 months;
4. Stable metabolic control as indicated by levels of glycated hemoglobin (HbA1c) \<7.5% on two consecutive measurements before study enrollment;
5. Body mass index (BMI) level ≥30 Kg/m2 during the 3 months preceding randomization.

Exclusion Criteria:

1. Chronic treatment with corticosteroids and/or chronic treatment with non-steroidal inflammatory drugs, defined as ≥3 times/week with the rationale that these drugs independently impact on the whole inflammatory state;
2. Clear indication for dual antiplatelet therapy and/or anticoagulant therapy (full dose);
3. Active cancer or cancer in complete remission from less than one year, except for treated early-stage squamous or basal cell skin carcinomas;
4. For women with childbearing potential, pregnancy.
Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction

The purpose of this study is to assess and compare the conditions for tracheal intubation obtained with Modified Time Principle Induction (MTPI) and that obtained with classic induction (CI). This study will compare the efficiency of tracheal intubation with the two induction techniques, as well as evaluate for potential adverse events.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>30 kg/M2 or Mallampati class III or IV
* Requiring general anesthesia and endotracheal intubation

Exclusion Criteria:

* Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma
* American Society of Anesthesiologists (ASA) physical status classification \> III
* Emergency surgery
* Induction requiring cricoid pressure
* Patients requiring awake intubation
* Pregnant women
* Patients who require an induction dose of propofol less than 1 mg/kg
* Untreated ischemic heart disease
* Contraindication to mask ventilation
* Allergy to propofol, rocuronium, or Sugammadex
* Induction requiring succinylcholine
Effect of Simvastatin Treatment on Vaso-occlusive Pain in Sickle Cell Disease

The purpose of this study is to determine whether simvastatin is effective in reducing the frequency and intensity of vaso-occlusive pain episodes in patients with sickle cell disease.

Sickle cell disease (SCD) is characterized by recurrent vaso-occlusive episodes and a chronic inflammatory state leading to progressive multi-organ injury. The pathophysiology of SCD is related to endothelial dysfunction driven largely by impaired nitric oxide (NO) homeostasis and chronic inflammation. Through multiple mechanisms, including upregulation of NO, statins have been shown to confer protection from endothelial injury, independent of their cholesterol-lowering properties.

By inhibiting inflammation and several common pathways leading to vascular damage,simvastatin may help prevent the acute and chronic complications of SCD. The objective of this study is to determine whether our preliminary results showing simvastatin-associated reductions in plasma markers of vascular injury will translate into a reduction in vaso-occlusive pain episodes in patients with SCD. A web-based, smartphone-accessible electronic pain diary will be used to monitor frequency and intensity of vaso-occlusive pain in SCD patients treated with a single daily dose of simvastatin.

Eligibility Criteria:
Inclusion Criteria:

* Sickle cell disease (HbSS or S/β0 thalassemia)
* ≥ 3 vaso-occlusive pain episodes in the year prior to enrollment
* Age ≥ 10 years
* Weight \> 30 kg

Exclusion Criteria:

* Creatine kinase (CK) \> UNL
* Total cholesterol \< 90 mg/dL, or triglycerides \<30mg/dL
* Renal dysfunction (Creatinine \> 1.5-fold UNL)
* Hepatic dysfunction (ALT \> 2-fold UNL)
* Treatment with drugs having known metabolic interactions with statins within the past 30 days
* Vaso-occlusive pain requiring hospitalization within past 30 days
* Red blood cell transfusion within the past 30 days
* Pregnancy/lactation
* Musculoskeletal disorder associated with an elevated CK level
* Past or present history of substance abuse (alcohol, cocaine, amphetamines, heroin)
* Chronic pain caused by avascular necrosis of the bone (AVN) or leg ulcers, and pain due to trauma or causes other than SCD.
* Major cognitive or neurological impairments that may hamper the ability to use the smartphone or complete the electronic pain diary in this study
Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer

It is studied whether multi-parametric biomarkers such as speed-of-sound imaging or others, applied during breast ultrasound (BUS) imaging allows to classify lesions according to its malignancy. The standard reference intervention is BUS guided biopsy or the consensus of the board of experts judging the BUS imaging results if no biopsy is done.

Patients with a palpable lump in the breast or suspicious findings in X-ray mammography typically undergo breast ultrasound examination as a supplemental imaging modality. Findings are then used for tumour classification according the American Collage of Radiology (ACR) Breast Imaging Reporting and Database System (BI-RADS) lexicon. Suspicious findings then undergo ultrasound-guided biopsy, which causes discomfort for the patient and introduces high emotional stress, and may involve - albeit very-small - risk of complications (such as bleeding and infections).

Today conventional breast ultrasound B-mode images do not have the specificity to reliably differentiate malignant and benign tissues in all cases and hence a biopsy intervention or close follow-up is necessitated. Multiparametric imaging bio-markers such as the novel method of speed-of-sound imaging may provide additional indicators to help to better classify lesions prior to biopsy and avoid any further work-up.

The study collects data with an ultrasound device during normal BUS examination which is then retrospectively processed to extract the desired multi-parametric BUS (mp-BUS) information of imaged tissue.

Eligibility Criteria:
Inclusion Criteria:

* Women who are suspected or suspected of having breast cancer and who are advised to perform a detailed breast ultrasound or tissue sampling (biopsy)
* Classification into groups:

  * Group 1: Foreseen for BUS guided biopsy
  * Group 2: BI-RADS classification I, II and III and foreseen for BUS only based diagnosis

Exclusion Criteria:

* Lactating women
* Women with mastitis
* Vulnerable persons
Stimulation TcPO2 Test in the PAD Diagnosis in Diabetic Foot

All diagnostic procedures of peripheral arterial disease (PAD) in the diabetic foot (DF) are limited due to diabetes mellitus and its late complications. The aim of our study is to refine the diagnosis of peripheral arterial disease (PAD) by a new transcutaneous oximetry (TcPO2) stimulation test (a modified Ratschow test) in patients with diabetic foot.

Patients with diabetic foot and mild to moderate PAD (WIfI - Ischemia 1 or 2) with baseline TcPO2 values 30-50 mmHg will be included into the study. TcPO2 will be measured on the feet in different angiosomes. During this measurement a stimulation test consisting of a modified Ratschow test involving 2 minutes of exercise will be conducted. Specific TcPO2 parameters will be assessed during the whole procedure (resting TcPO2 before stimulation test, minimal TcPO2, delta TcPO2 (minimum TcPo2 minus resting TcPO2) percentage decrease of TcPO2 during the stimulation test and TcPO2 recovery time (time to the adjustment of TcPO2 to the resting values).

All TcPO2 parameters detected during TcPO2 stimulation test will be correlated with parameters of macrocirculation (systolic blood pressures (SBP) on tibial arteries and their Ankle-Brachial Indexes (ABI), toe pressures (TP) and toe-brachial indexesTBI) and DUS findings (monophasic/triphasic flow in relevant artery supplying measured angiosome)

Eligibility Criteria:
Inclusion Criteria:

* presence of Diabetic Foot in patients with type 1 or type 2 diabetes mellitus, with WIfI classification of ischemia 1-2 (based on TcPO2) without previously diagnosed PAD or with known PAD based on the patients' history or previous vascular reconstruction (endovascular or surgical vascular interventions)
* resting TcPO2 values between 30-50 mm Hg.

Exclusion Criteria:

* vascular interventions on evaluated limb within 12 months prior to the enrolment into the study
* factors possibly influencing for example oxygen saturation or feet movement:

  * patient imobility
  * impairment of movements at the talocrural joints
  * vasculitis
  * heart failure or advanced COPD
  * severe anaemia (plasma haemoglobin below 8g / dL)
  * hypoperfusion due to shock or cardiac dysfunction
  * sepsis
  * massive swelling of the lower limbs of various ethiology (including lymphedema)
  * active Charcot osteoarthropathy
  * critical limb ischemia with WIfI classification of ischemia 3
  * lower limb claudication below 200m
  * venous insufficiency of CEAP classification 6
  * severe diabetic kidney disease (CKD stage 4 or 5)
The Use of Liposomal Bupivacaine in TAP Blocks for Women Undergoing Cesarean Section

This present investigation aims to determine whether a transversus abdominous plane(TAP) block, utilizing liposomal bupivacaine (Exparel), at the conclusion of a cesarean section decreases post-operative pain. The hypothesis is that performance of the TAP block with liposomal bupivacaine will decrease post-operative narcotic use.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Scheduled cesarean section with or without bilateral tubal ligation
* Planned performance of a Pfannenstiel incision
* Patients are schedule to have a cesarean section with a member of the Women's Health or Maternal and Fetal Medicine Departments at Penn State University Hershey S. Medical Center

Exclusion Criteria:

* History of opioid use
* History of chronic pain syndrome
* Use of general anesthesia during cesarean delivery
* Postoperative SICU admission
* Postpartum hemorrhage (defined as an Estimated Blood Loss of greater then 1,000mL upon completion of the cesarean section)
An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk

The purpose of this study is to determine whether a skin cancer prevention website is effective at reduce female teenagers' desire to use indoor tanning and ultimately their use of indoor tanning over an 18 month period.

The project is designed to improve the understanding of, and ability to affect UV risk behavior in teenage populations. The International Agency for Research in Cancer classifies indoor tanning as "carcinogenic to humans." There is evidence that female indoor tanning use increases dramatically from freshman to senior years of high school (e.g., 25-40% of older high school girls) making high school a critical time period for anti-tanning interventions to be carried out. This proposal assesses the effectiveness of a skin cancer prevention website for a nationally representative sample of high school teens in a randomized controlled trial. Teens exposed to the website will report reduced indoor tanning intentions, frequency and overall percentage of users while increasing sun protective behaviors at long-term (i.e 18 month) follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Teenager between 12 and 18 years old; has either indoor tanned in the past year or has indicated their intentions to indoor tan in the coming year.

Exclusion Criteria:

* None other than not meeting inclusion criteria.