cyrilzakka/clinical-trials huggingface dataset:
A Case-control Study to Assess the Association Between Environmental, Domestic and Occupational Exposures and the Risk of Testicular Germ Cell Tumor

The incidence of testicular germ cell tumors, the most common cancer in men aged 15 to 45 years, has doubled in France in 30 years. Reasons remain unclear but a role of environmental factors, especially during critical periods of development, is strongly suspected. Reliable data on environmental exposure during this critical period are sparse.The discordant findings and the limitations of available studies underline the importance to conduct studies with sufficient statistical power to detect risk due to exposures during critical windows of vulnerability.

We conduct a multicentric case-control study to assess this association. Cases and controls will be enrolled during a 18-month period. They will be interviewed by professional telephone interviewers about their occupational and residential history and about their domestic exposure to pesticides and other nuisances.

An optional biological study to assess genetic polymorphisms known to be associated with testicular cancer will be proposed to every cases and controls.

Mothers (or close relative) of cases and controls will also be contacted (with son's agreement). If they agree to participate, they will also be interviewed about antenatal and early life exposure of their sons to pesticides and other nuisances.

Cases will be matched up with 2 controls (one of each group) both on age (+/- 2 years) and on recruiting center.

Environmental exposure to pesticides will be assessed from subject's residential history, using a Geographic Information System.

Occupational exposure to pesticides and other nuisances will be assessed by an industrial hygienist who will be in charge to encode all subjects and mothers' occupations.

Domestic exposure to pesticides will be assessed from type, target and frequency of domestic pesticide use.

Based on these 3 sources of exposure, a score of exposition will be calculated for each case and each control.

Eligibility Criteria:
Inclusion Criteria:

* Men aged between 18 and 44 years old
* Born in metropolitan France
* Able to understand, read and write French
* Without any psychiatric and severe cognitive disorder
* Willingness to participate to the study
* Who has signed and dated an inform consent form
* Affiliated to a health care system

Exclusion Criteria:

* Who has a legal guardian
* History of testicular germ cell tumor or cryptorchidism (only for controls)
Simplified Severe Sepsis Protocol in Zambia

This study is a randomized control trial assessing the impact of a simple evidence-based protocol for the treatment severe sepsis in Zambia. The intervention protocol consists of a scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood transfusion when necessary. It is hypothesized that the protocol will significantly decrease in-hospital mortality in patients with severe sepsis.

In recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. However, in sub-Saharan Africa, simple therapies such as IV fluids and early antibiotics are frequently under-utilized. Furthermore, although tuberculosis is a common cause of severe sepsis in the region, accurate and timely diagnosis of tuberculosis-associated severe sepsis remains elusive.

The aims of this study are (1) To assess the impact on survival of a simple evidence-based protocol for severe sepsis, (2) To evaluate the cost of implementation for a simplified severe sepsis protocol (3) To develop a clinical diagnostic score for identifying tuberculosis in HIV positive patients with severe sepsis (4) To assess the performance of the Xpert TB/RIF rapid PCR system for diagnosing tuberculosis in HIV positive patients with severe sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Suspected infection
* 2 or more of SIRS criteria:

  * Heart rate \>90/min
  * Respiratory rate \>20/min
  * Temperature \>= 38° C or \<= 36° C
  * White blood count \> 12,000 or \< 4,000/µL
* 1 or more of the following signs of end-organ dysfunction

  * Systolic blood pressure \< 90 mm Hg
  * Mean arterial blood pressure (MAP) \< 65 mm Hg
  * Confusion/altered mentation
  * Urine output \< 0.5 mL/kg/hr
  * Creatinine increase \> 0.5 mg/dL
  * Creatinine \> 0.5 mg/dL above upper limit of normal
  * Platelet \< 100x109/L
  * Respiratory rate \> 40/min
  * Jaundice

Exclusion Criteria:

* GI bleed
* Need for urgent surgery
Testing New Formats for the Presentation of Research Evidence to Health Care Managers and Policy Makers

The purpose of this project is to identify and use our knowledge on the barriers and facilitators to using systematic reviews (SR) by health care managers (HCM) and policy markers (PM) to develop and test a novel format for presentation of SR for HCM and PM. We will invite HCM and PM from hospitals and regional authorities in Ontario, Alberta, and British Columbia to participate in a randomized-control trial. Participants will receive a link to an online consent survey, and then be randomly allocated to receive access to a novel SR or its traditional presentation. There is no time limit to completing the task, and participants are able to save their responses and finish later. Participants are able to withdraw from the study by not completing the task.

Despite advances in the conduct and reporting of traditional systematic reviews, current evidence suggests that they are used infrequently by health care managers and policy makers in decision making. Managers and policy makers have suggested that concise presentation positively affects the use of systematic reviews. The purpose of this randomized controlled trial is to assess the impact of a traditional systematic review format compared with the innovative format on the ability of health care managers and policy makers to understand the evidence in the review and apply it to a relevant health care decision making scenario.

The two end-user groups have different formatting needs and we will therefore run 2 parallel studies, randomizing each group separately. Once participants have consented to participate, a computer generated randomization process will allocate them to one of 2 arms (1:1 ratio). Participants will either receive either a traditional format or a novel format. Unequal block randomization will be used and allocation will be concealed through central assignment. Outcomes assessors will be blinded and participants will be blinded to the citation of the review so that the traditional version will not be easily accessible in its original format from the relevant journal.

This study will be the first study to engage health care managers and policy makers in the testing of formats for presentation of research evidence relevant to their needs. The results of the project will help increase the uptake of systematic review results in health care management policy decision-making, ultimately leading to informed decision making and positively impacting the health of Canadians.

Eligibility Criteria:
Inclusion Criteria:

* Health care managers from the Alberta SCNs, CAHO in Ontario, the RHAs and AQESSS in Quebec and RHAs from BC will be invited to participate.
* Policy makers/analysts from the Ontario, BC, Alberta and Quebec Ministries of Health

Exclusion Criteria:

* Health care managers or policy makers who are unwilling or unable to give informed consent.
Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis

This study aims to evaluate the efficacy and safety of parecoxib versus indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). It is a single-center, prospective, randomized, controlled, exploratory trial. Participants will be randomly assigned to receive either parecoxib or indomethacin as a preventive treatment. The primary endpoint is to compare the efficacy of the two drugs in reducing the incidence of PEP. Secondary endpoints include the incidence of moderate to severe PEP and post-ERCP-related adverse events. This study will systematically assess the efficacy and safety of both drugs, providing preliminary data for future larger confirmatory trials.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years.
* Patients scheduled to undergo ERCP for conditions such as common bile duct stones, benign or malignant biliary strictures, cholangitis, suspected biliary tumors, unexplained jaundice, or pancreas divisum.

Exclusion Criteria:

* Previous papillectomy.
* Previous endoscopic sphincterotomy (EST) without planned pancreatic duct intervention.
* Simple biliary stent removal or replacement without planned pancreatic duct intervention.
* Biliary-duodenal fistula, post-biliary-duodenal anastomosis, or post-biliary-jejunal anastomosis.
* Malignant tumor of the pancreatic head.
* Currently or recently (within 1 week) suffering from acute pancreatitis.
* Current or recent (within 1 week) use of NSAIDs.
* Recent (within 2 weeks) or within 4 weeks prior to surgery, gastrointestinal bleeding or peptic ulcers.
* History of significant adverse reactions to NSAIDs.
* Renal insufficiency (creatinine clearance \&lt; 30 mL/min).
* Moderate to severe hepatic impairment (Child-Pugh score ≥ 7).
* Severe cardiovascular or cerebrovascular disease.
* Patients with psychiatric disorders.
* Pregnant or breastfeeding patients.
* Patients without a rectum.
* Patients unwilling or unable to provide informed consent.
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers

The Primary purpose of this study is to identify the recommended Phase 2 dose \[RP2D(s)\] for JNJ-63723283 in Part 1, to assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in participants with selected advanced cancers including non-small-cell lung cancer (NSCLC), melanoma, renal, bladder, small-cell lung cancer (SCLC), gastric/esophageal cancer, and high-level microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer (CRC) in Part 2, to determine one or more additional RP2Ds in Parts 3 and 4.


Eligibility Criteria:
Inclusion Criteria:

* Parts 1-4: Have an Eastern Cooperative Oncology Group \[ECOG\] performance status 0 or 1
* Parts 1-4: Has thyroid function laboratory values within normal range
* Parts 1-4: Females of childbearing potential must have a negative serum pregnancy test
* Parts 1-4: Willing and able to adhere to the prohibitions and restrictions specified in this protocol
* For Part 2 only: Participants enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy
* Parts 1 to 4: Have evaluable disease

Exclusion Criteria:

* Has uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure (New York Heart Association class III-IV), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements
* Has had prior treatment with an anti-Programmed-cell death receptor-1 (PD-1) antibody, anti-the ligand to programmed-cell death 1 (PD-L1) antibody or anti-the ligand to programmed-cell death 2 (PD-L2) antibody
* Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 half lives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration
* Grade 3 or higher toxicity effects from previous treatment with immunotherapy
* A female who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study drug
A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder

The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD) (Diagnostic and Statistical Manual-IV \[DSM-IV\], 300.02).
* HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both Screening and Baseline/Randomization.

Exclusion Criteria:

* Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder;
* Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder; Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder
* Current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.
Long Term Follow-Up of Patients on Children's Cancer Group Protocols- (CCG-LTF1) FOLLOW-UP DATA

This protocol is not an independent research study, but rather a means to aggregate Children's Cancer Group protocols that are closed to patient entry for the purpose of collecting current status information on those patients treated under those protocols.

Children's Cancer Group clinical trials are conducted to improve understanding of the biology and treatment of childhood cancers. Protocols are developed by expert committees and distributed from the Group Operations Center to the member institutions. Before a protocol can be opened to patient accrual at a CCG institution, the protocol, consent form and any activation amendments are reviewed and approved by the local Institutional Review Board QRB).

Protocols remain open to patient accrual until sufficient evaluable patients have been entered to answer the study questions. During this time, the protocol and any new amendments are reviewed annually by the IRB. When the study has been closed to patient accrual it remains open solely for the purpose of collecting life status and occurrence of adverse events. The IRB must continue its annual review as long as a patient treated on the protocol is alive and follow-up data are being collected. The CCG Long Term Follow-up protocol (CCG-LTF1) is meant to allow continued collective review of all protocols that meet the following criteria: (a) It is closed to patient accrual, (b) all patients have completed treatment, and (c) there are patients who are alive and being followed. The protocols that meet these criteria will be listed as being aggregated under CCG-LTF1 such that an IRB review of CCG-LTF1 will constitute a review of that protocol.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have completed anti-cancer treatment according to a CCG protocol, or must have been declared off protocol therapy, but not off study.
* The data to be collected on the patient must include only those data that are documented in the medical record or included on the follow-up forms.

Exclusion Criteria:

* n/a
A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies

Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects with Advanced Solid Malignancies

Part 1 of this trial will determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) and the safety profile of tisotumab vedotin in subjects with solid malignancies. Part 2 of this trial will enroll subjects with cervical cancer to provide further data on the safety, tolerability, PK and anti-tumor activity

Eligibility Criteria:
Inclusion Criteria (Main):

* PART 1 ONLY: Subjects with locally advanced or metastatic solid tumors, who have experienced disease progression while on standard therapy or are intolerant of, or not eligible for, standard therapy.
* PART 2 ONLY: Subjects with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progressed on standard of care chemotherapy in combination with bevacizumab, if eligible.

Patients must not have received more than 2 prior systemic treatment regimens for recurrent or metastatic cervical disease.

* Measurable disease according to RECIST v1.1
* Must be at least 20 years of age on the day of signing informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration
* Women of childbearing potential must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration
* A man who is sexually active with a WOCBP and has not had a vasectomy must agree to use a barrier method of birth control (Part 1 only)
* Must provide signed informed consent before any trial-related activity is carried out.

Exclusion Criteria (Main):

* PART 2 ONLY: Clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage.
* Known past or current coagulation defects leading to an increased risk of bleeding.
* Ongoing major bleeding.
* Has an active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible
Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk

Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers.

It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.

Static or reactive overlay mattresses are an example of a low-tech constant low-pressure support. Static air mattresses maintain a continuous low air pressure that exerts a pressure redistributing effect. Serraes and Beeckman found a pressure ulcer incidence of 5.1% in patients placed on static air support (mattress overlay, heel wedge and seat cushion) in a high risk population in a nursing home setting in Belgium.

The CuroCell SAM PRO (Care of Sweden AB) is a static air mattress overlay system used as prevent and treat pressure ulcers (up to category 3) and for pain therapy. The aim of current study is to measure pressure ulcer incidence on the CuroCell Sam PRO static air mattress in nursing home residents at risk for pressure ulcer development over a 30-day period in Belgium.


Eligibility Criteria:
Inclusion Criteria:

* At risk of pressure ulcer development based on a Braden score ≤ 17
* Bedbound or chair bound
* Aged ≥ 65

Exclusion Criteria:

* Short-stay residents (expected length of stay ≤14 days)
* End of life care
* Medical contraindication for patient repositioning/turning
* Pressure ulcer Cat. II+ present on initial evaluation
Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty:

Total knee arthroplasty is a common and effective surgical procedure for patients with end-stage knee osteoarthritis, and wound pain is still a problem for many of the patients.

Therefore, the purpose of this study was to apply low level laser therapy Measured variables included postoperative pain intensity, patient-controlled analgesia requirements, side effects caused by morphine, knee stiffness and wound pain in the daily activities of patients undergoing total knee arthroplasty. Data were collected between April 2018 and January 2019. Eighty-two knee osteoarthritis patients receiving total knee arthroplasty were recruited from one hospital and randomly, equally assigned to the laser acupuncture or control group. The LA group received the low-level laser therapy with 3 joules at each acupuncture point at Hour 2, Hour 6, Hour 10, Hour 24, Hour 48, and Hour 72 after surgery; whereas the control group received the same manner except for joule.

Eligibility Criteria:
Inclusion Criteria:

* age 60 years or older
* American Sociological Association (ASA) class I-III
* spinal anesthesia, consent to patient-controlled analgesia (PCA) and peripheral nerve block (PNB)
* return to the ward directly from the anesthesia recovery room.

Exclusion Criteria:

* cutaneous lesions at the application sites
* use of taking immunosuppressive agents
* received intra-articular steroid treatment
* opiate dependence
* sensitive to light
* epilepsy
* clinically significant cardiovascular diseases
* cancer
* systemic lupus erythematosus.
The Comparative Efficacy of Standard Treatment Plus Ribavirin vs Standard Treatment Alone in Preventing Clinically Significant Hemorrhage in Patients With Dengue Fever

This study investigates the comparative efficacy of standard treatment plus Ribavirin versus standard treatment alone in preventing clinically significant hemorrhage among patients diagnosed with dengue fever. It is a double-blind, randomized control trial aimed at determining whether the addition of Ribavirin improves clinical outcomes, particularly reducing bleeding events.

Dengue fever, a significant public health concern, presents varying severity from asymptomatic to life-threatening complications such as hemorrhage or shock. This study evaluates the effectiveness of Ribavirin when combined with standard treatment in mitigating severe bleeding complications in dengue patients. Conducted at multiple public sector hospitals in Khyber Pakhtunkhwa, the trial employs a rigorous methodology, including block randomization, double-blinding, and predefined eligibility criteria. Outcomes include changes in bleeding grades, platelet counts, acute-phase reactants, and hospital stay length. The findings aim to inform policy decisions and enhance dengue fever management protocols.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 years and above.
* Hospitalized patients diagnosed with dengue fever, confirmed via:
* Positive Dengue NS1 antigen test
* Dengue IgM antibodies
* Dengue RNA PCR.
* Patients presenting with various severities of illness, as classified by the WHO dengue severity classification.

Exclusion Criteria:

* Patients taking antiplatelet or anticoagulant medications.
* Patients with known bleeding disorders (e.g., hemophilia, von Willebrand disease, end-stage renal disease, or liver cirrhosis).
* Patients with HIV undergoing antiviral therapy.
* Pregnant women.
* Patients with hypersensitivity to Ribavirin.
* Patients with WHO Grade 1 bleeding (few petechiae without clinical significance).