cyrilzakka/clinical-trials huggingface dataset:
Paraspinous Anesthetic Block for Non-Responsive Pelvic Pain

This study examines randomized triple-blind clinical trial and the efficacy of paraspinous anesthetic block on the treatment of chronic pelvic pain in patients non-responsive to pharmacological management. Sixty patients will be randomly divided and allocated into group intervention (paraspinous anesthetic block) and control (placebo procedure in subcutaneous tissue).

Patients will be allocated into one of two groups (intervention or placebo), and will be submitted to the corresponding procedure (paraspinous anesthetic block or placebo puncture in subcutaneous tissue). In the first appointment, pain will be measured with the VAS (Visual Analogue Scale); quality of life and function basal level will be evaluated by scales SF-36 (Medical Outcome Short-Form (36)Health Survey)and FSFI (Female Sexual Function Index), in Portuguese validated versions. Procedure will be realized as planned for each group.

Second appointment will occur one week after the procedure, and VAS scale will be applied.

Third appointment will occur in one month. VAS scale will be applied again,and procedure will be repeated if patient does not have a reduction of at least 30% of pain.

Next consultations will occur at two months, three months, four months and five months, with application of VAS scale to keep monitoring evolution of pain.

At six months of study, VAS scale will be applied along with SF-36 and FSFI questionnaires, to evaluate improvement in pain and in quality of life and function level.

Eligibility Criteria:
Inclusion Criteria:

* Patients with benign pelvic pain non-responsive to pharmacological treatment, lasting at least 6 months, located in the anatomic pelvis, anterior abdominal wall, infra-umbilical region, lumbossacral region or buttocks. Pain must be hard enough to cause functional impairment or to motivate medical counseling. The absence of physical findings does not decreases the importance of pain, nether excludes the possibility of pelvic pathology.

Exclusion Criteria:

* Patients who do not want to take part in the study
* Age under 18 years old
* Pelvic pain lasting less than 6 months
* Relief or resolution of pain with pharmacological treatment
* Pain of neoplastic origin
* Known allergy or report of adverse reaction related to lidocaine
Does a Caffeine Gum Improve 5 km Run Performance in a Competition/Field Setting?

The purpose of this study is to determine whether caffeine gum improves the performance of runners completing free timed mass participation 5 km runs in the United Kingdom (UK)

The study will investigate the ability of an acute intake of caffeine gum to improve performance in recreationally trained runners completing park runs. Park runs are free, timed 5 km mass participation running events that are held in a number of parks around the UK every Saturday morning.

A total of 60 recreationally trained runners will be recruited to the study. Of these, 30 will be assigned to a randomised placebo-controlled double-blind cross-over trial. The remaining 30 will be assigned to a non-intervention comparison group. The non-intervention group will be used to account for the effect of changing environmental conditions on running performance.

All participants will complete two 5 km park runs separated by no more than 2 weeks. Participants on the intervention study arms will consume either caffeine or placebo gum 30 minutes before they run. The order of consumption will be randomised. The caffeine gum will contain 300 mg (with an approximate 85% bioavailability). Participants will be asked to abstain from any caffeine containing beverages or food for 18 hours before each run. They will also be asked to record their dietary intake for the day before and the morning of the run and to repeat this for their second trial. Physical activity on the days leading up to each 5 km run will also be recorded and participants will be asked to closely replicate their activity in the week leading up to each trial. They will also be asked to keep training intensity and duration light during the 48 hours leading up to each trial.

The primary outcome measure will be change in overall time for the 5 km runs. Other outcome measures will be ratings of perceived exertion, 1 km split times and average heart rate.

The study size was calculated using an online software package (http://www.sportsci.org/resource/stats/), adopting a power of 80% and an alpha of 0.05. Using within-person standard deviation from runners completing a local parkrun and an expected effect size of 1.2% (Bridge and Jones (2006) J Sports Sciences. 24(4):433-9) a sample size of 25 runners was calculated for the intervention study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult runners with evidence of having recently ran 5 km in under 25 minutes

Exclusion Criteria:

* Current musculoskeletal injury, history of adverse response to caffeine, presence or history of cardiovascular disease, heart rhythm disorders or hypertension.
Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection

Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there are extremely limited studies on the difference between insulin pump compared to MDI on the incidence of hypoglycemia and other acute complications during fasting Ramadan

The investigators hypothesized that insulin pump would be associated with less hypoglycemic events during fasting Ramadan compared to MDI without deterioration in glycemic control. Results of this study are descriptive but will fill a current gap in knowledge and may contribute to development of future guidelines for the management of type1DM during Ramadan.


Eligibility Criteria:
Inclusion Criteria:

1. DM type 1
2. Age ≥14 years
3. Patients on insulin pump (more than 3 months)
4. Patients on MDI (glargine or detemir combined with aspart or lispro) regimen
5. Diagnosis of type 1 DM of more than 6 months.
6. Willing to do Self Monitoring Blood Sugar (SMBG)
7. Have no other contraindication to fast

Exclusion Criteria:

1. Patient with renal or hepatic impairment
2. Patient with diagnosed adrenal insufficiency
3. Pregnancy
4. Alcoholism
5. Any diagnosed psychiatric disease
6. Can not do SMBG
COPANA - A09 PCSK 9 Substudy: Impact of Protease Inhibitors on PCSK9 Levels in Naive HIV-Infected Patients

Evaluation of the impact of initiation of protease inhibitor/ritonavir on PCSK9 levels in HIV-infected antiretroviral-naïve patients from the ANRS C09 COPANA cohort.

Background: HIV-infected subjects are at high risk of coronary heart disease (CHD) partly in relation with atherogenic dyslipidemia including increased triglycerides (TG) and LDL-cholesterol (LDL-C). Mechanisms of HIV-associated dyslipidemia are complex, involving HIV itself and some antiretrovirals (ARV), particularly protease inhibitors (PI/r). Elevated proprotein convertase subtilisin kexin 9 (PCSK9) level is associated with increased LDL-C in the general population. How PCSK9 level is regulated in HIV-infected treated patients has never been investigated.

Objectives: We aimed to identify factors associated with circulating PCSK9 concentration in ART-naïve and treated patients and to evaluate the impact of 1st line ARV therapy (ART) comprising a PI/r, on PCSK9 level in HIV-infected patients.

Methods: Fasting plasma concentrations of PCSK9 were measured using ELISA assay in HIV-infected individuals from the ANRS COPANA cohort, at ART initiation and after one year of PI/r-based therapy without any disruption. Subjects not virologically suppressed at follow-up, or taking any lipid lowering therapies at baseline or during follow-up were excluded. Spearman's correlation coefficient was used to determine the association between PCSK9 levels and metabolic parameters at baseline and under PI/r.

Eligibility Criteria:
Inclusion Criteria:

* Naive HIV-infected male or female \> 18 years
* Initiation of antiretroviral therapy including a protestase inhibitor during the follow up with blood samples available
* Patients controlled at one year with a VL\<400 copies/ml

Exclusion Criteria:

* Subjects under statin or other lipid lowering drugs (fenofibrate, ezetimibe)
A Trial to Examine the Efficacy of a Hand Serum and Glove Combination.

This is a virtual, 8-week, interventional crossover trial with 33 female participants aged 35 and older. The study aims to evaluate the efficacy of Habelo Beauty's Activating Hand Serum and Glove combination in improving hand skin health and appearance. During Weeks 1-6, participants will apply the Hand Serum to both hands daily. In Weeks 7-8, they will continue applying the Hand Serum and also wear a glove on one hand. Assessments will be conducted via questionnaires and photos at multiple time points to evaluate primary and secondary endpoints related to skin health parameters.


Eligibility Criteria:
Inclusion Criteria:

* Female, 35+ years old.
* Concerns about signs of skin aging on hands.
* Willing to discontinue other hand lotions or serums.
* Generally healthy, able to follow the study protocol.
* Access to someone to take hand photos at Baseline and Week 8.
* Consistent use of SPF for the duration of the study.

Exclusion Criteria:

* Chronic skin conditions on hands.
* History of skin cancer or pre-cancerous lesions on hands.
* Pregnant, breastfeeding, or trying to conceive.
* Inability to follow study protocol.
* Current significant medical procedures planned within the study duration.
* Severe allergies or reactions to product ingredients.
* Current or planned hand casting or splinting.
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes

This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
* Body mass index (BMI) 18.5-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Latitude - Lateral Lymph Node Attitude Study

Patients with advanced rectal cancer can sometimes have suspected tumour affected lymph nodes outside the standard operating field. These patients often receive preoperative treatment before surgery. There is a lack of consensus on what to do if there is remaining suspicion of tumour affected lymph nodes after the preoperative treatment. Removal of the lymph nodes using a broader surgical field with dissection of the lateral side-wall is often suggested, but the oncologic outcome is uncertain, and so is the patient reported outcome in terms of side effects.

This study aims to study the surgical treatment of tumour affected lateral lymph nodes to understand what lymph nodes require removal, and what effect that will have on oncologic outcome and the patient's function and QoL.

Patients with advanced rectal cancer will receive standard care, if lateral lymph nodes exist after neoadjuvant treatment they will be operated accordingly. The focus will be to compare two groups (with and without lateral lymph node clearance) regarding function, QoL and oncologic outcome.

We will also aim to identify features on MRI to improve diagnostic ability.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* written informed consent
* adenocarcinoma verified tumour below ≤ 8 cm from anal verge measured by rectoscopy and/or MRI
* clinical tumor (cT) stage cT3, cT4a or cT4b on MRI or
* adenocarcinoma verified tumour at any height ≤ 15 cm from anal verge measured by rectoscopy and/or MRI regardless of T/N stage with visible lateral lymph node (according to definition 2.4.2) on pre-therapeutic MRI or PET-CT

Exclusion Criteria:

* Not biopsy confirmed rectal cancer (adenocarcinoma)
* Recurrent rectal cancer
* Age below 18
* Participation in other trials in conflict with the protocol and end-points of the Latitude study
* No informed consent
Improvement of Support to Caregivers of Patients in Specialized Palliative Care at Home

The aim of the project is to evaluate the use of the caregiver-led 'CSNAT intervention' to identify, prioritize and address support needs among caregivers of patients who are starting in specialized palliative care at home in Denmark


Eligibility Criteria:
Inclusion Criteria:

* The caregiver and patient should be able to read and understand Danish
* The caregiver and patient should give written informed consent
* The patient should be newly referred to specialized palliative care (SPC) in the SPC unit.

Exclusion Criteria:

* The caregiver is viewed by the practitioners as being too distressed to be asked about participation
* The caregiver has a known cognitive impairment precluding participation (based on the practitioners' clinical judgement)
Individualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI

Background:Diabetes and smoking are common factors found to increase platelet reactivity in patients undergoing primary PCI. Objective: Compare the individualized and combined effects of smoking and diabetes on the antiplatelet activity in patients undergoing primary PCI. Methods: sixty patients were recruited in this study. Patients were allocated to one of four groups according to the diabetes and smoking status. Non smokers- non diabetic patients, smokers non diabetic patients, non smokers diabetic patients, and smokers diabetic patients, 15 patients in each group. All patients received 180 mg ticagrelor before PCI. Platelet reactivity index(PRI) and maximum platelet aggregation were measured 24 hours after ticagrelor loading dose for each patient as indicators for antiplatelet efficacy. PRI and/or MPA values \> 50% were defined as high platelet reactivity.


Eligibility Criteria:
Inclusion Criteria:

Acute coronary syndrome (ACS) undergoing PCI

Exclusion Criteria:

Patients who had a history of severe bleeding, serious bleeding tendency, history of intracranial hemorrhage, signs of active bleeding, thrombocytopenia, uncontrolled hypertension, hypersensitivity to the used drugs (clopidogrel or ticagrelor), concomitant use of strong CYP inducers or inhibitors, and/or severe liver disorders were excluded from the study.

Patients with previous history of coronary artery disease, previous PCI or patients administering other antiplatelets were excluded from the current study.
Quality of Friendships in Children With Neurofibromatosis

The aim of this study is to determine if children with a higher disease severity have lower quality friendships than children who are less severely affected and children who are unaffected. Researchers will test the hypothesis that the quality of friendships is inversely related to their disease severity.

Specific Aims:

1. To use the FQQ to determine if the quality of friendships in children with NF1 is lower than the quality of friendships in unaffected children.
2. To use a disease severity scale and the FQQ to determine if children who are less severely affected have higher friendship qualities than children who are more severely affected.

You (your) child will be asked to complete a short questionnaire (40 questions) about their relationship with their best friend. Doctors will review your (child's) medical chart to find out how severe the disease is, so that this may be compared to the answers you have (your child has) given on the friendship questionnaire.

This is an Investigational Study. About 90-100 children and adolescents with NF-1 will be asked to take part in this study. All will be enrolled at M.D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1) Patients with a clinical diagnosis of neurofibromatosis, type 1 (NF-1) who are between the ages of 8 and 18 years will be eligible. Patients must be English or Spanish speaking (test instrument will be translated into Spanish), and be able to read.

Exclusion Criteria:
BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry

The BIOFLOW-VIII registry is a post-market clinical evaluation of the Orsiro Mission stent in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

BIOFLOW-VIII is a national, prospective, non-randomized, multi-center, open-label registry to confirm both, the acute performance as well as the mid- and long-term safety and clinical performance of the Orsiro Mission stent in an all-comers patient population within daily clinical practice.

A total of 868 subjects will be enrolled at approximately 50 study sites in France. Clinical follow-ups will take place at 6, 12, 36 and 60 months post index-procedure. Follow-ups can be conducted by telephone.

A subgroup analysis will evaluate the outcomes for patients treated ambulatory with same day discharge.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic coronary artery disease intended to be treated with an Orsiro Mission DES (silent ischemia is permitted)
* Subject has signed informed consent for data release
* Subject is geographically stable and willing to participate at all follow up assessments
* Subject is ≥ 18 years of age

Exclusion Criteria:

* Subject did not sign informed consent for data release
* Pregnancy
* Known allergy (which cannot be pre-treated) to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt- chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), silicon carbide, PLLA, mTOR inhibiting drugs such as sirolimus, or contrast media
A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes

To investigate the efficacy and safety of RS-79070 when used as induction therapy in patients with newly diagnosed peripheral retinitis. To assess the effects of induction and maintenance level dosing of RS-79070 on CMV viral load, estimated by plasma CMV PCR. To assess the pharmacokinetics of ganciclovir following administration of RS-79070 in the target population.


Eligibility Criteria:
Inclusion Criteria:

* Documented AIDS diagnosis
* Newly diagnosed peripheral CMV retinitis
* More than 3 weeks of previous therapy for CMV retinitis
A Phase 3 Study to Evaluate Efficacy & Safety of Subcutaneous CT-P13 in Patients With Moderate to Severe Active Rheumatoid Arthritis

This is a Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients with Moderately to Severely Active Rheumatoid Arthritis


Eligibility Criteria:
\[Main Inclusion Criteria\]

1. Patient who is male or female aged 18 to 75 years old (both inclusive).
2. Patient who has a diagnosis of RA at least 24 weeks prior to the first administration of the study drug (Day 1) and fulfill the 2010 ACR/EULAR classification criteria for RA.
3. Patient who has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed), 6 or more tender joints (of 68 assessed), and either a high-sensitivity C-reactive protein (hsCRP) ≥1.0 mg/dL (≥10 mg/L) or an erythrocyte sedimentation rate (ESR) ≥28 mm/hour at Screening.
4. Patient who has been receiving the treatment of oral or parenteral dosing with MTX for at least 12 weeks and has been on stable dosing with MTX between 10 to 25 mg/week for at least 4 weeks prior to the first administration of the study drug (Day 1).
5. Patient who has adequate renal and hepatic function at Screening

\[Main Exclusion Criteria\]

1. Patient who has previously received investigational or licensed product; biological agents or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or a tumor necrosis factor (TNF) α inhibitors for the any purpose.
2. Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product.
3. Patient who has received or has plan to receive any of prohibited medications or treatments as defined in the protocol.
Socioeconomic Inequalities in the Diagnosis and Treatment of Colon and Ovarian Cancer in England Between 2016-2017

This study is a population-based, patient-level analysis of colon and ovarian cancer diagnoses in England over a 2-year period using a dataset created by linking NCRAS and NHS digital datasets. Our analyses will look into inequalities in the diagnostic and treatment pathway, and inequalities in treatment received, for those diagnosed with colon and ovarian cancer between 2016-2017.

Colon and ovarian cancer survival in England lags behind other comparable countries. There is also evidence of a deprivation gradient in survival in England, where those from the most deprived areas are more likely to experience a worse survival with the disease.

Inequalities in the diagnostic and treatment pathways, and in treatments received, may contribute to this deprivation gap in survival. This study will look at the secondary care diagnostic interval and the treatment interval to assess for any socioeconomic inequalities in both these intervals. This study will also look at anticancer treatments received (surgery, chemotherapy and the combination of both treatment modalities) to evaluate for any socioeconomic inequalities in treatments received.

Important variables will be adjusted for in statistical modelling, including age, co-morbidities, ethnicity and stage of disease

To evaluate for inequalities in treatments received and diagnostic and treatment intervals the study will use data from the cancer registry, Systemic Anticancer Therapy (SACT), Hospital Episodes Statistics, Diagnostic Imaging Dataset and Cancer Waiting Times datasets. These datasets will be linked by the National Cancer Registration and Analysis Service, using a unique identifier. We will receive a pseudo-anonymised dataset, allowing for patient-level analyses but without identifying individual patients.

Eligibility Criteria:
Inclusion Criteria:

All patients resident in England and aged 18-99 diagnosed with colon cancer (ICD10 C18) or ovarian cancer (ICD10 C48, C56, C57 and D39,1) where the date of diagnosis is between 01/01/2016 and 31/12/2017.

Exclusion Criteria:

Patients with cancers of the appendix (C18.1) will be excluded.

Male patients with ovarian cancer.

Borderline ovarian tumours (ICD-10 site code of C56x, C57x or C48x where the morphology code is: 8442, 8444, 8451, 8463, 8473, 8472 or 8462) and (ICD-10 site code D39.1 where the morphology code is 8144, 8260, 8313, 8380, 8381, 8440, 8441, 8460, 8470, 8480, 8481, 9000, 9013, 9014 or 9015).

Sarcomas are excluded (where the morphology code is: 8693, 8800-8806, 8963, 8990-8991, 9040-9044, 8810, 8811-8921, 9120-9373, 9490, 9500, 9530-9582).

Patients diagnosed with any prior invasive primary malignancies (ICD10 C00-97x), where the date of diagnosis of such prior invasive malignancies precedes the diagnosis date of the first qualifying tumour. Patients with a synchronous diagnosis on the same day as their qualifying tumour will be included within the sample population.

Incomplete registrations excluded.