cyrilzakka/clinical-trials huggingface dataset:
An Evaluation of the Outcomes of Bariatric Surgery - a Cohort Study

A prospective bariatric database was carried out in the Department of Digestive and Endocrine Surgery at the University Hospital of Strasbourg, France, starting in January 1996. All potential candidates for obesity surgery were prospectively registered in the database. Patients were informed by the bariatric surgeon of the prospective database, and of the possibility of utilizing personal data for research purpose after anonymization.

A case-control study was performed, to compare the quality of life (QoL) of patients treated for internal hernia (IH group) with the QoL of patients with an uncomplicated course after Roux en Y gastric bypass (Uncomplicated RYGB group).

A prospective bariatric database was carried out in the Department of Digestive and Endocrine Surgery at the University Hospital of Strasbourg, France, starting in January 1996. All potential candidates for obesity surgery were prospectively registered in the database. Patients were informed by the bariatric surgeon of the prospective database, and of the possibility of utilizing personal data for research purpose after anonymization. Patients were evaluated by a multidisciplinary team. The standard preoperative assessment included nutritional counseling, psychological evaluation, abdominal ultrasound, upper gastrointestinal endoscopy, and blood tests. Type and date of surgery, biological and clinical follow-up data and morbidity data were recorded prospectively in the database.

A case-control study was performed, to compare the quality of life (QoL) of patients treated for internal hernia (IH group) with the QoL of patients with an uncomplicated course after Roux en Y gastric bypass (Uncomplicated RYGB group). Patients who had IH were paired with patients of the same age and sex and at the same postoperative interval. Paired patients were contacted by phone to obtain the QoL questionnaires, abdominal pain evaluation, and weight loss data.

Eligibility Criteria:
Inclusion Criteria:

* patient \>18 years old
* BMI \> 35 kg/m²

Exclusion Criteria:

* Incapacity of giving an informed consent
Blue Note Therapeutics Product BNT 103 Usability and User Engagement

This test aims to explore product development-focused usability and user engagement.

Sponsor is testing an innovative peer-to-peer communication tool during this trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient can read, write, and speak in English
* Patient is between the ages of 35-55
* Diagnosed with Stage I-III breast cancer
* In active treatment or within 3 months of ending active treatment and under the care of a clinician at time of study
* Apple mobile phone or tablet user
* Willing to participate in study protocol

Exclusion Criteria:

* Any participant not meeting inclusion criteria
A comparatiVe Study on Efficacy and Safety of Lipegfilgrastim in Comparison to Pegfilgrastim in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia

The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated Independent Ethics Committee (IEC)-approved written informed consent
2. Age ≥65 years and ≤85 years
3. Histological documentation of aggressive B cell NHL
4. Planned to receive systemic anticancer therapy with at least 6 cycles of R-CHOP-21, according to local standards
5. ECOG score ≤2
6. Life expectancy of at least 3 months
7. Adequate bone marrow, renal and hepatic function within 14 days before start of chemotherapy
8. The patient is capable of understanding and complying with parameters as outlined in the protocol
9. Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment and for 30 days after discontinuation of study drug.
10. The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using an approved method of birth control and agrees to continued use of this method for the duration of the treatment (and for 90 days after taking the last dose of study

    * Other Criteria apply, please contact the investigator for more information

Exclusion Criteria:

1. Participation in a clinical study within 30 days before randomization
2. Any chemotherapy within the last 3 months before start of chemotherapy. A prephase to reduce tumor burden prior to start of R-CHOP is allowed.
3. The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
4. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of chemotherapy.
5. Active cardiac disease
6. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of chemotherapy.
7. Ongoing infection, known history of human immunodeficiency virus (HIV) infection, tuberculosis, or chronic hepatitis B or C.
8. Patients with evidence or history of bleeding diathesis.
9. Non-healing wound, ulcer or bone fracture.
10. Renal failure requiring hemo- or peritoneal dialysis.
11. Any conditions that may interfere with the patient's participation in the study or evaluation of the study results.
12. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
13. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
14. Treatment with lithium at screening or planned during the study.

    * Other Criteria apply, please contact the investigator for more information
Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System

The objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the Clinical Evaluation Report for the Ortho Development Hip System.

Long term surveillance of survivorship and complications can help to identify pre-surgical comorbidities, perhaps leading to a lower risk of implant failure and subsequent revision surgery. By understanding the role of comorbidities in the specific population, it is possible to increase patient outcomes and satisfaction, while reducing the costs associated with complications and revision surgeries.

This study consists of prospective collection and analysis of data for a consecutive series of patients that underwent total hip arthroplasty with the Ortho Development Ovation® Hip System at the study site between 2012 and December 2015. It is estimated that over 400 patients received the subject system. Each of these patients will receive a survey within the mail when they approach, or have exceeded, their five-year post-surgical time period.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is five years post total hip arthroplasty
* Patient received the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components
* Patient agrees to participate in the survey.

Exclusion Criteria:

* Patient does not have the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components
Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by Streptococci

The primary objective of the study is to compare the clinical efficacy of 5 days (800 mg x 4) versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin (PcV) in adults, adolescents and children with streptococcal tonsillitis. Patients are recruited from 17 primary Health care centres in the south of Sweden. Adult men and women, youth and children ≥ 6 years of age who are visiting the primary Health care for sore throat with suspected tonsillitis and meeting the criteria in accordance with current treatment recommendations for pharyngotonsillitis, ie 3-4 Centor criteria (fever≥ 38.5, tender lymph nodes, coatings of the tonsils and absence of cough) and a positive rapid antigen detection test (RADT) for Group A streptococcus (GAS) will be included in the study. Patients will be randomized to be prescribed PcV of 5 and 10 days. Each patient or guardian fills daily in a short diary including aches, fever, PcV doses, pain relievers, adverse events etc. Five to seven days after last intake of PcV the general practioner make a clinical judgement if the patient has recovered from the pharyngotonsillitis. Questions to be asked are if remaining symptoms or new symptoms of sore throat is present, if adverse events have been noted or of any extra physician visits have been made. Throat swab for semi quantitative cultures of Streptococcus group A, C and G are made at randomization and five to seven days after last intake of PcV. A study nurse will contact the patients one month and three months after the last treatment day for follow-up. If the patient has reconsulted or been hospitalised for a sore throat or possible complication, those patient records will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Adults, adolescents and children ≥ 6 years of age with verified streptococcal pharyngotonsillitis.

Exclusion Criteria:

* Signs of serious infection.
* Known hypersensitivity against penicillin.
* Chronic disease with effect on the immune response.
* Immunosuppressive treatment.
* Streptococcal tonsillitis within one month (relapse).
A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa

The RESOLVE trial is an open, parallel arm, randomized clinical trial which aims to determine the optimal strategy for management of virologic failure on antiretroviral therapy (ART) with tenofovir, lamivudine, and dolutegravir (TLD) in sub-Saharan Africa. The primary outcome of interest will be viral suppression to \<50 copies/mL at 48 weeks using the FDA snapshot definition. The study will be conducted in Uganda and South Africa.

The RESOLVE trial is an open, parallel arm, randomized clinical trial which will be conducted at public-sector HIV clinics in Uganda and South Africa. We will enroll individuals with HIV age 15 and above who have had two HIV-1 RNA viral load results \>1,000 copies/mL while on TLD and who have been on TLD for at least 12 months. Participants will be randomized using an equal allocation ratio of 1:1:1 across three study arms: a) Standard of Care (regimen guided by genotypic resistance tests and care as per guidelines in Uganda; and with regimen selection and possible genotypic resistance testing (GRT) and care as per guidelines in South Africa), 2) Individualized Care with regimen choice based on results of genotypic resistance tests and urine tenofovir adherence assays, or 3) Immediate Switch to PI-based second-line ART. Randomization will be stratified by clinic, prior exposure to non-nucleoside reverse transcriptase inhibitors, and virologic failure history. We will follow participants for one year with study visits at enrollment, Week 24, and Week 48. The primary outcome of interest will be viral suppression to \<50 copies/mL at 48 weeks using the FDA snapshot definition.

Eligibility Criteria:
Inclusion Criteria:

* Age 15 years and above
* Enrolled in HIV care at one of the study clinics
* History of two HIV-1 RNA viral load measurements \>1,000 copies/mL while on TLD
* On TLD for at least 12 months
* Lives within 100 kilometers of study clinic

  * Pregnant women are eligible for enrollment.

Exclusion Criteria:

* Plans to transfer out of the clinic within the next 48 weeks
* Plans to move out of the study catchment area within the next 48 weeks
* As determined by chart review, we will exclude those with known virologic failure on protease inhibitors or exposure to integrase strand transfer inhibitors other than dolutegravir.
Comparison of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Central Venous Catheter

This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation, total bacterial count, dressing intactness and cost-benefit, nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter.

This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation, total bacterial count, dressing intactness and cost-benefit, nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter.

154 eligible patients in our HD center will be enrolled consecutively and randomly allocated to one of the two groups according to computer-generated randomization sequences in a 1:1 ratio. Experiment group use semi-permeable film as dressing in exit-site of CVC, and a sterile gauze and tape in control group. Both groups share same disinfection and dressing change procedure. Dressings will be replaced per hemodialysis session, or as needed. Socio-demographic data and disease-related information will be collected, as well as catheterization site, physician, skin and exit status of the catheterization site at baseline. Data as listed in the beginning will be recorded in the next 2 weeks follow-up at every session, such as sign of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation and dryness, dressing intactness. Before the 2nd dressing change, skin around exit of CVC under dressing area will be swabbed by a cotton swab. Nursing time of dressing change will be recorded by a third nurses. Cost and benefit will be calculated and compared by the end.

Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years; requiring hemodialysis treatment by non-tunneled CVC inserted through subclavian vein, femoral vein, internal jugular vein by nephrologists team, allowing sufficient blood flow; competent to provide informed consent.

Exclusion Criteria:

* current systemic antibiotic therapy as a result of bacteremia in the previous 21 days; pregnancy; with a known dermatitis at the exit site or known hypersensitivity to a component of either dressing; require antibiotic lock or antibiotic ointment in exit-site for infection prevention locally
Concomitant Infection of Intestinal Parasites and Helicobacter Pylori

Intestinal parasitic infections such as Giardia lamblia, Entamoeba histolyica and Enterobius Vermicularis are among the most common infections worldwide.So parasitic infections are considered one of the major health problems in the world especially in developing countries.

Helicobacter pylori is a gram-negative,helical-shaped,motile bacillus bacterium,which colonizes the gastric mucosa.

H.pylori bacterium secretes urease,a special enzyme that converts urea to ammonia.

Ammonia reduces the stomach's acidity .This risk factor allows pathogenic intestinal protozoa such as G.lamblia to take the opportunity to cross through the stomach's increased pH and cause disease.


Eligibility Criteria:
Inclusion Criteria:

* patients complaining of dyspepsia , abdominal burning pain,diarrhea,dysentery,of persons of any age or sex group.

Exclusion Criteria:

* patients taking antibiotics within the previous four weeks, proton pump inhibitors within the previous two weeks, or anti-parasitic drugs within the previous two weeks.
To Evaluate the Efficacy and Safety of LIZTOX in Subjects with Benign Masseteric Hypertrophy

A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the efficacy and safety of LIZTOX in subjects with benign Masseteric hypertrophy


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject over 19 years of age and written informed consent is obtained.
* Subject who has bilaterally symmetrical of masseter at visual and palpable assessment.
* Subject who average masseter muscle thickness of at least 14mm on each side in males and 12mm in females at maximum clenching by ultrasonography.
* Subject who has a masseter muscle hypertrophy scale of 4(marked) or more as determined by investigator.
* Subject who fully understands this clinical trial and voluntarily writes ICF in the clinical trial.

Exclusion Criteria:

* Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.
* Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in masseter muscle area within 48 weeks prior to the study entry.
* Subject who has a disease(e.g. Temporo mandibular joint disorder, etc.)
* Subject who were diagnosed Myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that might influence with neuromuscular function.
* Subject who had taken medication(e.g. muscle relaxant, polypeptide antibiotics, aminoglycoside antibiotics, etc.) within 4 weeks prior to the study entry.
* Subject who are hypersensitive to investigational drug components (botulinum toxin, serum albumin, etc.)
* Subject who are pregnant or lactating or planing pregnancy or disagreed to avoid pregnancy during study period.
* Subject who participate other clinical trials within 4 weeks prior to the study entry.
* Subject who are not eligible for this study at the discretion of the investigator.
Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of of HZBio1 in Healthy Subjects

This randomized study will evaluate the safety, tolerability ,pharmacokinetics, pharmacodynamics and Immunogenicity of single ascending intramuscularly administered doses of HZBio1 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Fully informed and signed informed consent form;
2. Healthy subjects, male and female;
3. At the time of signing the informed consent, they were over 18-45 years old (including 18 and 45 years old) and weighed more than 50 kg,

   Body mass index ranged from 19 to 26 (including 19 and 26) \[body mass index (BMI) = body weight (kg) / height 2 (M2)\];
4. The results of serum pregnancy test in women of childbearing age were negative;
5. The subjects agreed to use effective contraception or abstinence during the study period and within 6 months after the end of the study;
6. Be able to understand and comply with the clinical protocol requirements, and it is expected to complete the whole trial process.

Exclusion Criteria:

1. History of hypertension or abnormal blood pressure at screening / baseline (SBP \> 140 mmHg and / or DBP \> 90 mmHg confirmed twice a day)
2. According to the researcher's judgment (clinical urine routine examination, proteinuria 2 + and above), proteinuria or proteinuria history with clinical significance.
3. Any previous VEGF and VEGFR antibody or protein therapy within one year.
4. No biological products or live virus vaccine shall be used for treatment for 3 months before the first administration of the study drug, or any monoclonal antibody shall be used for 12 months.
5. History or evidence of hereditary bleeding, coagulopathy, or thrombosis.
6. History of gastrointestinal perforation or fistula.
7. Severe, unhealed wounds, active ulcers, or untreated fractures, or were randomly assigned or expected to require major surgery during the course of the study or within 2 months after the last administration of the study drug.
8. RX or OTC drugs or nutritional supplements were used within 5 half lives before the first administration of the study drug or within 2 weeks (depending on the longer period). Herbal supplements need to be discontinued 28 days before the first administration of the study drug.
9. HBsAg, HCV antibody, HIV antibody and syphilis were positive
10. Known allergy to bevacizumab or any excipient
11. Known allergic diseases or allergic constitution
12. There was a history of unpaid blood donation within 3 months before taking the study drug for the first time
13. Use any other study drug for treatment or participate in other clinical trials within 3 months before screening
14. There was a history of alcohol or drug abuse within 12 months before screening; subjects were not able to control within 72 hours before and throughout the study
15. History of mental illness
16. During the study, the partner was expected to be pregnant.
17. During the study period, it did not conform to the clinical study protocol.
18. Other conditions not suitable for this study were considered by the researchers
GALNT4 in Patients With Acute Coronary Syndrome

The expression of GALNT4 in blood with acute coronary syndrome

Emerging evidences have linked GALNTs to cardiovascular disease or susceptibility to CAD.GALNT4, a member of the GalNAc-Ts family,contributes to the initiation of O-linked. Polymorphisms in GALNT4 have been linked with incidence of MI in an Irish population, probably that O-glycosylation of PSGL-1 by GalNAc-T4 may be important for many P-selectin mediated inflammation.However, there is few relevant studies about the expression of GALNT4 in patients with acute coronary syndrome.This study valuates the expression of GALNT4 in patients with acute coronary syndrome.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as acute coronary syndrome,including STEMI,NSTE-ACS,or diagnosed as SAP by CAG.

  * with left ventricular ejection fraction（LVEF）\>=45%
  * written informed consents are obtained
  * admitted within 24 hours after chest pain attacked(except SAP)

Exclusion Criteria:

* • complicated with rheumatic heart disease, coronary arteritis, hypertrophic cardiomyopathy or dilated cardiomyopathy

  * complicated with malignant tumor,the immune system diseases, blood system diseases, recently (within 2 weeks) taking glucocorticoid drugs, the use of immunosuppressive agents and cerebral infarction
  * with acute or chronic infection, surgery or trauma in the last month
  * secondary hypertension, severe liver dysfunction,severe renal insufficiency
  * with abnormal thyroid function or allergy to iodine agent
  * refusal to sign the informed consent
The Effect of Hydroxyethylstarch 6% 130/0.4 in a Balanced Electrolyte Solution (Volulyte®) Compared to Gelatine (Geloplasma®) on Microvascular Reactivity and Tissue Oxygen Saturation During Haemodilution Measured With Near-infrared Spectroscopy

The aim of this study is to compare 6% hydroxyethyl starch (HES) 130/0.4 in a balanced electrolyte solution (Volulyte®) with modified fluid gelatin (Geloplasma®) as the priming solution for the cardiopulmonary bypass (CPB) circuit. The microvascular reactivity and the effects on tissue (StO2) and cerebral (ScO2) oxygen saturation will be examined using near-infrared spectroscopy (NIRS).


Eligibility Criteria:
Inclusion Criteria:

Adult consenting patients scheduled for elective coronary artery bypass grafting surgery on moderately hypothermic (\> 32°C) CPB without blood transfusion. Age ≥ 18 years.

Exclusion Criteria:

Exclusion criteria are an ejection fraction \< 25%, a known allergy to HES, admission of HES or gelatines within the preceding 2 weeks, renal insufficiency (creatinine \> 2.0 mg/dl), significant hepatic disease (liver function tests \> 3x upper limit of normal), history of cerebrovascular disease, significant carotid artery stenosis (\> 60%), perioperative use of corticosteroids, and need for vasopressor or inotropic therapy before surgery. An expected haematocrit on CPB, calculated based on preoperative haematocrit, calculated blood volume and amount of cardioplegia, of \< 23% is also considered an exclusion criterium