cyrilzakka/clinical-trials huggingface dataset:
An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

This study was conducted to demonstrate that Gardasil™ (quadrivalent human papillomavirus \[qHPV\] vaccine) 1) is well tolerated in young men, 2) reduces incidence of external genital lesions in young men, 3) reduces the incidence of anal intraepithelial neoplasia (AIN) or anal cancer in men having sex with men (MSM), and 4) reduces incidence of Human Papillomavirus (HPV) infection in young men. In the 7-month Base Study participants received randomly assigned qHPV vaccine or placebo at Day 1, Month 2, and Month 6. Base Study follow-up continued through Month 36. In Extension 1 (EXT1), participants who received placebo or an incomplete qHPV vaccine regimen in the Base Study were offered qHPV vaccine. Participants were followed in EXT1 for 7 months. In Extension 2 \[LTFU (EXT2)\], long-term effectiveness, immunogenicity, and safety of qHPV vaccine were followed up to 10 years following study enrollment. Participants who received ≥1 dose of qHPV vaccine in the Base Study or EXT1 were eligible to enroll in LTFU (EXT2).


Eligibility Criteria:
Inclusion Criteria:

* Healthy heterosexual males between the ages of 16 years and 23 years and 364 days. Healthy men having sex with men (MSM) between the ages of 16 years and 26 years and 364 days.
* No clinical evidence of genital lesions suggesting sexually-transmitted disease, and no history of anogenital warts
* Additional criteria will be discussed with you by the physician

Exclusion Criteria:

* Concurrently enrolled in a clinical study involving collection of genital specimens
* History of known prior vaccination with an HPV vaccine
* Received an inactivated vaccine within 14 days or a live virus vaccine within 21 days prior to enrollment
* History of a severe allergic reaction that required medical intervention
* Received any immune globulin or blood-derived products within 6 months prior to the first study injection
* History of splenectomy, immune disorders, or receiving immunosuppressives
* Immunocompromised or diagnosed with HIV infection
* Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
* History of recent or ongoing alcohol or drug abuse
Dose-finding of Lenalidomide as Maintenance in Multiple Myeloma

This study is a Phase I (non-randomized) study evaluating three dose-levels of Lenalidomide in patients after allogeneic stem cell transplantation, accomplished in two institutions (University Medical Center Hamburg-Eppendorf/ University Medical Center Heidelberg).


Eligibility Criteria:
Inclusion Criteria:

* Understand and voluntarily sign informed consent form
* Age \> 18 years at the time of signing the informed consent form
* Able to adhere to the study visit schedule and other protocol requirements
* Multiple myeloma patients who received allogeneic stem cell transplantation (100 to 180 days ago)
* No active acute GvHD (grade II - IV)
* No active infectious complications
* ECOG performance status of \< 2 at study entry
* Laboratory test results within these ranges:

  * Absolute WBC count \> 3.0 x 10\^9/l
  * Platelet count \> 80 x 10\^9/l
  * Serum creatinine \< 1.5 mg/dl
  * Total bilirubin \< 1,5 mg/dl
  * AST (SGOT) and ALT (SGPT) \< 3 x ULN
* Females of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse for at least 28 days before starting study drug, while participating in the study and at least 28 days after discontinuation from the study.
* male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days after discontinuation of study drug
* disease free of prior malignancies for \> 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast

Exclusion Criteria:

* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
* pregnant or breast feeding females
* use of any other experimental drug or therapy within 28 days of baseline
* known hypersensitivity to thalidomide
* concurrent use of other anti-cancer agents or treatments
* known positive for HIV of infectious hepatitis, type A, B, or C
Participatory Intervention Among Construction Workers (IRMA11)

There is high prevalence of back pain and neck-shoulder pain among blue collar workers. Physical excessive exposures such as heavy lifting or working with a bended or twisted back are independent risk factors for back pain among workers in the construction industry. Participatory ergonomic initiatives increase the success of interventions aimed at reducing physical excessive exposures.

The objectives are in two phases to; 1) determine which work-tasks in selected job-groups involve the highest load of the back and shoulders during a normal working day (using EMG, Actigraphs, Video). 2) investigate whether a participatory intervention can reduce physical workloads, drawing on information from objective measurements from phase 1.


Eligibility Criteria:
Inclusion Criteria:

* Full time construction workers who are member of a labor union and can read and understand Danish.
* The type of work must include manual work that involves lifting

Exclusion Criteria:

* life-threatening diseases
* pregnancy
* hypertension \>160/100 mmHg
* unable to participate in the measurements
Laparoscopic Versus Open Left Colonic Resection

The main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection.

268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term morbidity, quality of life, and 5-year survival have also been evaluated.

The study design was explained to the potential participants who were asked to sign a written informed consent before randomization.

Eligible patients were randomly allocated to LPS or open surgery. Randomization list was computer generated. Assignments were made by means of sealed sequenced masked envelopes which were opened, before the induction of anesthesia, by a nurse unaware of the trial design.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* suitability to elective surgery

Exclusion Criteria:

* cancer infiltrating adjacent organs assessed by computed tomography
* cardiovascular dysfunction (New York Heart Association class \> 3)
* respiratory dysfunction (arterial pO2 \< 70 mmHg)
* hepatic dysfunction (Child-Pugh class C)
* ongoing infection
* plasma neutrophil level \< 2.0x109/L
Effect of New Oral Anticoagulants Dabigatran and Rivaroxaban on Point of Care Coagulation Testing - an Ex-Vivo Study

The purpose of this study is determine whether point of care coagulation testing is able to map the anticoagulatory effects of new oral anticoagulants dabigatran and rivaroxaban. Used as devices are thrombelastometry/-graphy (ROTEM, TEG)and multiple platelet function analyzer (Multiplate).

Patients receiving dabigatran or rivaroxaban in therapeutic doses are recruited. Blood will be taken twice in correlation to the time of drug intake (before and 3 hours after drug intake). The results of thrombelastometry/-graphy and multiple platelet function analyzer will be compared directly with the concentrations determined by plasma concentration assays.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving Dabigatran or Rivaroxaban
* Adults \> 18 years

Exclusion Criteria:

* Patients receiving concomittantly inhibitors of platelet function
* Renal insufficiency (Creatinine \> 1,5 mg/dl), Urea \> 80 mg/dl)
* Hemodialysis
* Hepatic Dysfunction (AST \> 30 U/l, ALT \> 30 U/l)
Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children

The purpose of this study is to determine whether a nutritional supplement is effective in the treatment of malnutrition in pediatric patients with failure to thrive or cystic fibrosis.

This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a nutritional supplement on nutritional status in children with failure to thrive or cystic fibrosis. Patients will be randomized to receive either a symbiotic formula with DHA and antioxidants or a standard formula.

Eligibility Criteria:
Inclusion Criteria:

* Malnutrition (P / T \<-1 SD) by intake deficit without organic disease (failure to thrive) and / or patients diagnosed with Cystic Fibrosis).
* Age \>= 1 year.
* Stable patients
* No antibiotherapy in the last 30 days
* Inform consent signed (parent/legal representative)

Exclusion Criteria:

* Patients with allergy / intolerance to cow's milk proteins
* Metabolically unstable patient
* Patients with metabolic intolerance to carbohydrates
* Patients with severe disease in the last 30 days
Assessment of the Patients of Emergency Consultation

The demographic data, mortality rates and clinical diagnoses of the patients who were evaluated, intubated and interned to ICU by the anesthesiology department due to an urgent consultation call from the emergency department in 2010-2011.

Primary outcome: an examination of demographic data, predicted mortality rates and the clinical diagnosis of the patients Secondary outcome: to determine the terminal cancer ratio Inclusion criteria: patients throughout the hole hospital whom was intubated by the anaesthesiology team due to an emergency consultation call Exclusion criteria: patients who refused treatment

The demographic data and findings completed in the Emergency Department were obtained from the patient cards and information related to existing diseases was obtained from the patient records for the cases included in the study.

Predicted mortality values were calculated for each patient with Apache II and SAPS II values using the worst or most critical physiological and laboratory parameters in the first 24 hours in the Emergency Department.

Eligibility Criteria:
Inclusion Criteria:

* patients throughout the hole hospital whom was intubated by the anaesthesiology team due to an urgent consultation call

Exclusion criteria:

* patients who refused treatment
Deep Brain Stimulation for Obsessive-compulsive Disorder

The goal of this clinical trial is to evaluate the treatment method of deep brain stimulation (DBS) in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder (OCD). DBS will be administered into the brain area of the bed nucleus of stria terminalis (BNST).

The main research questions are:

* Does active DBS in BNST reduce OCD symptoms (primary outcome)?
* Does active DBS in BNST reduce anxiety or depressive symptoms and improve the level of daily function?

The participants will be randomized to active or sham DBS in the BNST for six months and we will measure the outcomes before DBS surgery, and six months post-surgery. After the randomization phase, the participants will enter an open-label phase and receive continuous DBS in BNST. Yearly follow-ups will be conducted. The outcomes will be measured through interviews using validated psychometric scales.


Eligibility Criteria:
Inclusion Criteria:

* OCD diagnosed according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
* The patients should have received at least 16 sessions of cognitive behavioral therapy, tried three different serotonergic antidepressants in adequate doses for three months, and one serotonergic antidepressant in combination with a neuroleptic drug.
* Severe OCD symptoms: YBOCS ≥ 25 points.
* Substantial incapacity because of his/her symptoms.
* Duration of symptoms: 5 years minimum.
* Understand the consequences of participation in the study and give informed written consent.

Exclusion Criteria:

* Not being able to understand the consequences of the treatment.
* Diagnosed with intellectual disability according to DSM-IV.
* Not meeting the requirements for the neurosurgery procedure.
Impact of Renal Function Availability to Community Pharmacist for Dispensing Direct Oral Anticoagulant in Ambulatory Patients on Bleeding Occurrence

The use of direct oral anticoagulants (AODs) in the prevention and treatment of thromboembolic diseases is increasing, with a favorable benefit/risk balance and improved quality of life for patients. However, anticoagulants are still associated with a risk of bleeding, making them one of the drugs most likely to cause adverse events and serious adverse events. Certain clinical situations are particularly at risk of bleeding with AODs, notably renal failure (even moderate) and age over 75, due to the predominant renal elimination of these drugs. Prescription and monitoring of AOD treatment are conditional on monitoring of renal function and, if necessary, appropriate dosage adjustments.

Community pharmacists dispense AODs on a daily basis, following pharmaceutical analysis. Good dispensing practice recommends that community pharmacists have access to biological data. Studies have suggested that access to renal function enables community pharmacists to carry out targeted and appropriate interventions. This expected clinical pharmaceutical expertise is conditional on access to this biological data. In practice, community pharmacists are not systematically aware of this renal function, and are therefore unable to carry out a pharmaceutical intervention if necessary. Initiatives implemented by general practitioners seem to be emerging (systematic addition of the renal to the medical prescription), but these practices do not currently guarantee systematic access to this data. A strong argument in favor of systematically making the renal available to community pharmacists would be to demonstrate that access to this biological data reduces the occurrence of adverse events linked to AODs.

The main objective is to study the benefit of access to the patient's renal function by the dispensing pharmacist when dispensing an AOD (first prescription or renewal) on the occurrence of clinically significant bleeding at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* with a prescription for an AOD (first prescription or renewal),
* whatever the indication of the AOD treatment,
* coming to one of the study's partner pharmacies for dispensing,
* adults,
* agreeing to take part in the study (by signing the informed consent form).

Exclusion Criteria:

* prescribed another class of anticoagulant,
* minors,
* pregnant and breast-feeding women
* who do not understand French
* protected by law (guardianship, curatorship, safeguard of justice),
* refusing to take part in the study.
Correlation Between In-vivo Anatomy of Corneal Dystrophies as Assessed by High- Resolution Optical Coherence Tomography (OCT) Measurement and Histological Examination

Corneal dystrophies are usually classified histopathologically according to the layer of the cornea that is affected. The International Committee for the Classification of Corneal Dystrophies (IC3D) takes this anatomical classification as referral with summarizing clinical, genetic, and pathological data.

Most of this classification relies on slit lamp findings or histologic specimen, since in-vivo imaging of corneal microstructures has only become available in the recent years. With confocal microscopy it is possible to image corneal microstructures at a high resolution, but this technique is limited by its reduced repeatability and the fact that only a small area can be imaged. By the use of optical coherence tomography (OCT) systems it is possible to overcome these limitations. Commercially available systems, however, only have an axial resolution of about 18 µm which is not sufficient for imaging of all corneal layers.

Recently, a high-resolution optical coherence tomography (OCT) system was developed at the Center for Medical Physics and Biomedical Engineering that enables a resolution of about 1 µm. With this resolution, all corneal structures and several pathologies can be visualized.

In the present study the investigators want to use this OCT system to image corneal dystrophies in patients scheduled for corneal transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* Presence of corneal dystrophy
* Scheduled for corneal transplantation (PK, ALK, DALK, DSAEK or DMEK)
* No previous corneal surgery in the study eye

Exclusion Criteria:

* Participation in a clinical trial in the previous 3 weeks
* Presence of any abnormalities preventing reliable measurements as judged by the investigator
* Pregnancy, planned pregnancy or lactating
Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly

Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.

For this reason this study is looking at a different regimen of reducing the intensity of the treatment.

The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects.

There will be about 30 people taking part in this study. This study has one study group. All the people on the study will receive radiation therapy once a day, 5 days a week (for a total of 55 Gy over 5 weeks) and chemotherapy, cisplatin, (given through the vein for about 30-60 minutes) once a week for 5 weeks.

Medications and saline solutions to prevent side effects of chemotherapy may also be given by vein and may prolong your time in the chemotherapy clinic to as much as 4-6 hours.

Standard regimen not delivered on this study pertains to radiation therapy and chemotherapy, cisplatin in a schedule of 5 treatments a week for a total of 69.96 Gy over 6.5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls)
* Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
* P16-positive based on local site immunohistochemical tissue staining
* Clinical stage T1-3, N1-2, M0 (AJCC, 8th ed.)
* Age ≥ 65.
* Normal organ and marrow function within 14 days prior to registration defined as follows:
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Hemoglobin ≥ 8.0 g/dL
* Total bilirubin ≤ 1.5× institutional upper limit of normal (ULN)
* AST(SGOT) or ALT(SGPT) ≤ 3.0 × institutional ULN
* Serum creatinine ≤ 1.5× ULN

Exclusion Criteria:

* Metastatic disease
* Recurrent disease after primary management Cancers with center of mass is outside the oropharyngeal boundaries
* Synchronous double primaries
* Prior radiotherapy for lymphoma or other malignancy
* Prior systemic therapy including immunotherapy
* Severe active comorbidity where life expectancy is \<1 year.
* Autoimmune disease
* Uncontrolled HIV
Recovery of Bupivacaine or Bupivacaine-Lidocaine Spinal Anesthesia and Infiltration Anesthesia in Herniorrhaphy

The purpose of this study is the investigation of whether adding lidocaine to hyperbaric bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy procedures.

Consecutive 93 patients undergoing inguinal herniorrhaphy will be recruited with a prospective protocol.Spinal anesthesia will be commenced in Group BLS with 2 ml hyperbaric bupivacaine (10 mg) + 0.6 ml 1 % lidocaine (6 mg), in Group BS, hyperbaric bupivacaine (10 mg) + saline in the same volume and Group LIA will have anesthesia with bupivacaine and lidocaine for step by step local anesthetic infiltration. Sensorial block will be measured with pinprick test, motor block will be tested with Bromage scale. Heart rate, blood pressure and peripheral oxygen saturation will be measured every 5 minutes. Time of subarachnoid injection, onset of sensorial block (block at L1 dermatome), time to block T10 dermatome, maximum block level, time to maximum block and time to two segment regression, T10 regression , LI regression and S1 regression of the block will be recorded in group BLS and BS.The onset and resolution of the sensorial and motor block will be assessed by anesthetists blinded to group allocation. PACU stay and discharge times and VAS pain scores will be recorded in all patients. Patients also will be investigated for adverse events (hypotension, bradycardia, nausea,PDPH, TNS, urinary retention)and satisfaction regarding the anesthetic method.

Eligibility Criteria:
Inclusion Criteria:

* Patients having inguinal hernia
* Not hypersensitive to study drugs
* ASA classification I-III

Exclusion Criteria:

* ASA classification IV-V
* Contraindications for spinal anesthesia