cyrilzakka/clinical-trials huggingface dataset:
Predicting, Understanding and Speeding Recovery After TKA

The objective of this research study is to better understand patterns of recovery after Total Knee Arthroplasty (TKA) amd Total Hip Replacement (THA). The study will evaluate how pain, activity and cognitive (i.e., thinking style) responses determine patterns of recovery, and the study will evaluate the efficacy of gabapentin versus placebo for improving recovery after surgery.

The investigators propose a two-site, longitudinal, double-blind, randomized clinical intervention study to examine three specific aims:

Aim 1: Characterize the dynamic pain experience, activity, and cognitive response after TKA and determine patterns of recovery in these domains

Aim 2: Test whether gabapentin alters time course of recovery after TKA or THA in a manner dependent on its interaction with pre-drug pupil diameter and preferred style in the catastrophizing-optimism dimension

Aim 3: Test whether gabapentin increases pupil diameter in patients undergoing TKA or THA who are on high dose opioids preoperatively and to examine whether opioid use moderates the associations in Aim 1

Primary Hypothesis: Novel variance beyond established associations in recovery from pain following TKA or THA surgery is accounted for by the interaction between pupil diameter and Cognitive-Affective (C-A) state, and this interaction predicts efficacy of gabapentin to speed recovery.

Key secondary hypotheses: Disability, impulsivity, and attentional deficits recover after TKA or THA surgery follow a log of time pattern, and are predicted by C-A state and its interaction with pupil diameter. Gabapentin increases resting pupil diameter in patients scheduled for TKA who are receiving high doses of opioids.

Eligibility Criteria:
Inclusion Criteria:

* Adults scheduled for elective total knee or hip replacement
* American Society of Anesthesiologists physical status 1-3
* Participants must be able to read and write English

Exclusion Criteria:

* Inability to complete questionnaires
* Pregnancy
* Litigation or workers compensation related to joint surgery
* For 250 subjects in primary analysis - taking \< 100 mg morphine equivalents/day. For 50 subjects to test gabapentin's effect on pupil diameter - taking \>100 mg morphine equivalents/day
* history of Raynaud's disease of the feet
* suffering from a psychotic disorder or a recent psychiatric hospitalization
* history of eye surgery or topical eye medications that would render pupillometry unreliable or would directly affect pupil diameter.
* any disorder that would affect pupil responsivity or prevent accuracy of pupillometry such as movement disorders
Perinatal Outcomes in Patients With Elevated sFlt-1/PlGF Ratio

Retrospective cohort study that evaluated 190 subjects admitted with diagnosis of hypertensive disorder of pregnancy, between 24 and 36 6/7 weeks, with an sFlt-1/PlGF index greater than or equal to 110. Data were collected on their clinical course prior to termination of pregnancy, using the last reported sFlt-1/PlGF ratio value to classify the population into four cohorts: values between 110-205, between 206 and 654, between 655 and 999 and greater than 1000.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hypertensive disorder of pregnancy
* Gestational age between 24 - 36 6/7
* sFlt-1/PlGF \> 110

Exclusion Criteria:

* Gestational age below 23 6/7 weeks and above 37 weeks at the moment of admission.
* Absence of sFLt-1/PlGF ratio result.
Assessing the Effects of a Neurobehavioral Intervention on Symptoms of Obsessive Compulsive Disorder

This experiment will examine if the use of computerized tasks that train individuals to control their attention more effectively will predict individual differences in obsessive-compulsive symptoms, rumination and BDNF change. After giving consent, filling out self-report forms, and giving blood for the BDNF test, 80 participants will be randomized to Cognitive Control Training (CCT) or Peripheral Vision Task (PVT) (described below) which will be administered three times over a two week period. At the third visit, participants will also complete an anagram task and repeat the blood draw for BDNF testing. The investigators hypothesize that computerized tasks that train individuals to control their attention more effectively will reduce Obsessive Compulsive (OC) symptoms. Additionally, individuals training in CCT will show increased ability to disengage from unattainable goals as assessed by responses to an unsolvable anagram task. Finally, individuals training in CCT will show a greater increase in BDNF levels as compared to individuals training in PVT.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-65 years
* OCI-R total score ≥ 16
* Ability to read and provide informed consent.
* Familiarity with a computer keyboard and mouse.

Exclusion Criteria:

* BDI-II suicidality score of \> 1
The Endothelial Count in Pxf

Pseudoexfoliation Syndrome Is a common disorder in Egypt. IT is one of the common causes of coexisting cataract and glaucoma. It may be associated with a less than normal endothelial count.

The corneal Endothelium is essential for the maintenance of normal corneal hydration, thickness, and transparency.

In patients with pseudoexfoliation syndrome , quantitative and qualitative morphological changes of the corneal endothelium have been demonstrated in specular and electron microscopic studies.

Specular microscopy is a non-invasive technique to access the structure and function of the corneal endothelium.

Our research question is to study Endothelial cell count in patients with pseudoexfoliation syndrome \& compare it to age matched group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pseudoexfoliation syndrome

Exclusion Criteria:

* Patients with previous intra ocular surgeries.
* Patients with uveitis
* Patients with fuck's endothelial dystrophy
Study of CP-675,206 in Refractory Melanoma

CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.


Eligibility Criteria:
Inclusion Criteria:

* Surgically incurable Stage III or IV melanoma
* One prior systemic treatment for metastatic melanoma
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1

Exclusion Criteria:

* Melanoma of ocular origin
* Received prior vaccine
* Received prior CTLA4-inhibiting agent
* History of, or significant risk for, chronic inflammatory or autoimmune disease
* Potential requirement for systemic corticosteroids
Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis

Randomised trial comparing the efficacy and feasibility of using a sterile closing pack to reduce postpartum sepsis

Pregnant patients meeting the inclusion criteria undergoing elective or emergency caesarean section will be eligible for recruitment. Patients will be randomised into two arms. In the control arm sheath and skin closure will be performed with the instruments used to perform the caesarean section, as per the current standard of care. In the intervention arm, after suturing the uterine incision and obtaining hemostasis and before commencing closure of the sheath and skin, the surgical team (obstetrician, assistant and scrub sister) will don clean sterile gloves, open clean sterile linen to drape on top of the existing linen and open a pack of clean sterile instruments to close the sheath and skin.

Eligibility Criteria:
Inclusion Criteria:

* women 18 years and older willing and able to provide consent

Exclusion Criteria:

* women who are not able or willing to provide consent patients with existing maternal infection
Nerve Function in Older Diabetic Patients Who Are Undergoing Chemotherapy for Metastatic Solid Tumors

RATIONALE: Learning about the side effects of chemotherapy may help plan treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is studying nerve function in older diabetic patients who are undergoing chemotherapy for metastatic solid tumors.

OBJECTIVES:

Primary

* Determine changes in peripheral nerve function in older patients with diabetes and metastatic solid tumors treated with taxane or platinum-containing chemotherapy regimens.
* Determine the extent to which age, pre-existing diabetes mellitus, and level of glycemic control predict a differential pattern in outcome beyond the effect of the drugs in patients treated with these regimens.
* Develop a clinical assessment that would predict whether or not patients with diabetes mellitus are more or less susceptible to the neurotoxic effects of chemotherapy.

OUTLINE: This is a longitudinal study.

Patients undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control. Patients are evaluated at baseline, every 3 weeks during chemotherapy for up to 4 treatments, and at 2 months after completion of treatment.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of solid tumor

  * Metastatic disease (stage IV)
* Planning neoadjuvant or adjuvant treatment of locoregional definitive or systemic therapy comprising ≥ 1 of the following:

  * Taxane (paclitaxel or docetaxel)
  * Platinum (cisplatin, carboplatin, or oxaliplatin)
* Diagnosis of type I or II diabetes mellitus

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No other disease that reduces peripheral nerve function (e.g., HIV/AIDS, uremia, spinal injuries, alcoholism, or CNS problems)

PRIOR CONCURRENT THERAPY:

Chemotherapy

* See Disease Characteristics
* No prior chemotherapy
* No prior or concurrent neurotoxic drugs (i.e., vincristine)
Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars

Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old
2. Has unwanted scars not including atrophic scars and wishes to undergo laser treatments.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.
5. Has Fitzpatrick skin types I to IV.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
3. The subject has active or localized systemic infections.
4. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
7. The subject has used Accutane within 6 months prior to enrollment.
8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. The subject has a history of keloids.
11. The subject has evidence of compromised wound healing.
12. The subject has a history of squamous cell carcinoma or melanoma.
13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
14. The subjects has an allergy to lidocaine and epinephrine.
A Retrospective Review of Gemcitabine, Methylprednisolone Cisplatin (GEM-P) With or Without Rituximab in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)

There has been considerable international /national interest in the GEM-P regimen for treatment of patients with relapsed/refractory lymphoma. Currently, there is no accepted standard therapy for these patients. Since the publication of our experience with this regimen (Study with CCR ethics number 1857 closed to recruitment in July 2003:Ng M, Waters J, Cunningham D et al, Br J Cancer 2005;92:1352-7), we have treated relapsed/refractory lymphoma patients with this regimen and would like to undertake a retrospective review of a sub-group of these patients with diffuse large B cell lymphoma (DLBCL).

Patients treated with GEM-P with or without Rituximab prior to March 2005 for refractory/relapsed DLBCL will be included in the analysis. Accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment.

All patients accrued will give informed consent for retrospective case note review, after discussion with a study investigator and after receiving a study information sheet. All eligible patients identified from the pharmacy database, and will be consented at the time of the next clinic appointment, if they are agreeable for the retrospective case note review.


Eligibility Criteria:
Inclusion Criteria:

- a) Age over 18 b) Histological diagnosis of diffuse large B cell lymphoma c) Patients who have received Gemcitabine-cisplatin, methylprednisolone (GEM-P) as per standard unit guidelines with or without Rituximab for relapsed/refractory DLBCL.

d) Informed written consent

Exclusion Criteria:

* a) Medical or psychiatric conditions that compromise the patient's ability to give informed consent b) HIV positive or AIDS related lymphoma
Use of Smartphone Health Applications Among Patients Aged 18 to 69 Years Recruited in Primary Care in Grenoble Area

This study evaluates the frequency of use of smartphone health applications among people consulting in primary care in the Grenoble region, France.

This is a descriptive study using a questionnaire completed by the patient and distributed by general practitioners. The study also collects the type of used application as well as the rhythm of usage, and compares the use of mobile health applications according to the sociodemographic, geographical and medical characteristics of the studied population.

Smartphones are more and more present and change many aspects of people's life, especially in the field of health. The appearance of numerous mobile health applications over the past years explains this strong attractiveness.

According to some studies, these could lead to savings in health care systems by promoting a preventive approach and refocusing cares on the patient who would be more independent. However, not much data on the use of smartphone health applications by patients are reported in the scientific literature.

The main objective of this study is to evaluate the frequency of use of smartphone mobile health applications among primary care patients aged 18 to 69 in the Grenoble region, France.

The secondary objectives are the collection of the kind of application used, the rhythm of usage of these health applications and the comparison of the frequency of use with the sociodemographic, geographical and medical characteristics of the studied population.

To this end, the investigators use a questionnaire distributed by voluntary general practitioners and filled by patients. The number of subjects to be included is 385 and the number of distributed questionnaires is 1500.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged among 18 to 69 years old who consults a general practitioner regardless of the reason for consultation

Exclusion Criteria:

* patients aged 17 and less and patients aged 70 years and over.
* Patients not owning a mobile phone and / or smartphone for own
* Patients deprived of their liberty by judicial or administrative decision or subject to a legal protection measure
The Sleep Improving Effects of Orange Phenolics

This study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation can improve objective sleep duration and/or quality, and/or improve perceived sleep quality and feelings of rest.

Participants will complete a total of 9 test nights, which consist of sleeping with the sleep monitoring system after ingestion of the test product or a placebo, and filling out sleep-related questionnaires.

The study has a crossover design, meaning that all participants receive all three interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a randomized order.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* Non-smoking
* Healthy
* Lightly disturbed sleep for at least six months, on a regular basis

Exclusion Criteria:

* Severe sleep disorders (sleep apnea, restless legs syndrome)
* An apparent cause for the sleep disorders (pain, etc.)
* Clinically significant abnormal liver functioning
* Clinically significant abnormal serum creatinine
* BMI lower than 18 or higher than 30 kg/m2
* Use of concomitant medications or supplements
Genomic Dissection of a QTL Affecting the Lipid Profile

To search for the genetic cause of the metabolic syndrome, a lipid disorder that poses a major risk for coronary heart disease.

BACKGROUND:

The metabolic syndrome is a common disorder posing a significant major risk for coronary heart disease and early mortality in the Western hemisphere. Central to its cardiovascular complications is the association of the syndrome with the specific abnormalities in plasma lipid and lipoprotein profiles including increased plasma triglycerides, decreased HDL cholesterol, and predominance of dense lipoprotein particles. In search for the genetic etiology of this lipid disorder, the investigators identified a quantitative trait locus (QTL) on human chromosome 7q36 strongly linked to variation in plasma lipid levels. They hypothesize that this QTL contains genetic variants that contribute to alterations in biologic pathways underlying the genesis of the lipid disorder.

DESIGN NARRATIVE:

The study will search for the genetic cause of the metabolic syndrome, a lipid disorder that poses a major risk for coronary heart disease. The investigators have identified a quantitative trait locus (QTL) on human chromosome 7q36 strongly linked to variation in plasma lipid levels. The investigators hypothesize that this QTL contains genetic variants that contribute to alterations in biologic pathways underlying the genesis of the lipid disorder. To test for this hypothesis, they propose a comprehensive approach utilizing established resources and expertise to identify the functional sequence variants within this QTL. Specifically, they will 1.) identify single nucleotide polymorphisms (SNPs) and their haplotype and linkage disequilibrium structure across the entire QTL region; 2.) Analyze association of informative SNPs with plasma triglyceride levels, LDL levels, and lipoprotein density fractions using variance component linkage/disequilibrium analyses; and 3.) Identify potentially functional sequence variants in associated genes or genomic regions using Bayesian quantitative trait nucleotide analysis. This comprehensive application of newly available genomic technologies, novel statistical approaches, the DNA and phenotypic information available, and the consortium of expertise assembled behind this project will ensure the successful elucidation of the genetic etiology of this lipid disorder and consequently the development of effective means for prevention and/or treatment of cardiovascular complications of the metabolic syndrome.

Eligibility Criteria:
No eligibility criteria
Testing the Efficacy of Different Dosages of Lercanidipine to Reduce Hypertensive Blood Pressure in Normal Weight and Obese Patients

A double blind study to examine the safety and efficacy of different dosages of lercanidipine in normal weight and obese patients with hypertension


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI): 18.0 - 24.9 or 30.0 - 39.9 kg/m2 (extremes included);
* Essential hypertension I or II WHO:
* 140 mmHg ≤ BPs ≤ 179 mmHg and BPd ≤ 109 mmHg at the end of the placebo run-in phase;

Exclusion Criteria:

* Secondary hypertension;
* Diabetes mellitus type 1, insulin dependent diabetes mellitus type 2, fasting blood glucose ≥ 160 mg/dl;
* Subjects keeping to a hypocaloric diet (except special diet for diabetics) to reduce body weight;
* History or presence of angioneurotic oedema;
* Subjects developing a hypertensive crisis during wash-out or placebo run-in period;
D Mannose for Prevention and Treatment of RUTIs

The aim of this review is to address clinical reliability, efficacy and safety of long-term treatment with oral D Mannose for the prevention of recurrent urinary tract infections (RUTIs) in females.

A comprehensive systematic MEDLINE, Embase, Cochrane search was performed for English language reports published before December 2018 using the term "recurrent urinary tract infections and d mannose." We searched Medline, Embase, and the Cochrane Register of Controlled Trials since January 2010 to December 2018. Eligible studies did not include non-oral therapy, local (vaginal) treatment in women with RUTIs.

Study eligibility criteria- We identified eligible original articles. The heterogeneity of the available studies, their different rationale and aim, the assumption of d mannose for prophylaxis or treatment of recurrent UTIs need to be taken into account.

Eligibility Criteria:
Inclusion Criteria:

recurrent urinary tract infections (RUTIs)

Exclusion Criteria:

Upper urinary tract infections, severe clinical symptoms, fever \> 37,5 with lumbar pain