cyrilzakka/clinical-trials huggingface dataset:
A Longitudinal Quantitative Assessment of the Effectiveness of Metatarsal Pads on Plantar Pressures

Musculoskeletal deformities of the foot and abnormal biomechanics can create areas of high pressure over bony prominences on the plantar aspect of the foot and often lead to the formation of calluses and corns. Calluses and corns are reported to be the most prevalent foot conditions affecting peoples' lifestyles due to pain and disability. Redistribution of plantar pressure away from areas of high pressure offloading using felt pads to treat corns and calluses is a common practice in chiropody. A more comprehensive understanding of how rapidly the felt pads compress and become less effective in offloading pressure is needed to design better treatment plans to manage calluses and corns and improve patients' quality of life. The objectives of this study are: 1) develop a guideline which informs, at what duration (number of weeks) the semi compressed felt (SCF) Plantar Metatarsal Pad (PMP) should be replaced to manage plantar forefoot callus; 2) Test the guideline by replacing the SCF padding at the determined time interval. The study will be conducted at the Michener Chiropody Clinic at the Michener Institute of Education at UHN. In order to address patient selection bias, the investigators will be recruiting the first 25-40 participants presenting with forefoot callus who meet the inclusion criteria and consent to participate in the study. An exploratory, descriptive and analytic repeated measures study design will be used to address our research questions. The descriptive approach will provide insight into the nature of change over time in the dependent variables, pain and pressure, and an analytic approach will enable further insight into the relationship between those variables. The quantitative metrics used are average plantar pressure at the callus site, as well as self-reported pain using a Visual-Analog Scale (VAS). Results from the first phase will inform the development of the guideline for pad replacement, which in turn will be tested in the next phase of the study.


Eligibility Criteria:
Inclusion Criteria:

The participants to be studied are from the general population with callus on the plantar aspect of the forefoot. The participants must have appropriate footwear with adequate space for pads and must be agreeable to wearing them majority of the study period for weight bearing activities. Participants must be willing to attend clinic every two weeks for 8 weeks

Exclusion Criteria:

Participants with an active or past history of foot ulcers, those with Charcot neuroarthropathy as well as those who were unable to walk unaided will be excluded from the study. All participants will undergo a neuropathic assessment, including the vibration using a 127Hz tuning fork, protective sensation using a 10 gram monofilament and proprioception to exclude patients with neuropathy. Participants will be excluded if they have any foot skin disorders such as infections, dermatitis and psoriasis. Furthermore, anyone with neuropathy or diabetes for over 5 years will be excluded from the study.
Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)

To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥12 years and older inclusive of either sex.
2. Documented clinical history of PAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable.

Exclusion Criteria:

1. Pregnant or lactating women.
2. History of anaphylaxis and/or other severe local reaction(s) to skin testing.
3. History of positive test for HIV, Hepatitis B or Hepatitis C infection.
4. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
5. Subjects with an active pulmonary disorder or infection.
6. Subjects with posterior subcapsular cataracts or glaucoma
Antidepressant Effect of Theta-Burst rTMS

The aim of this study is to evaluate the safety and efficacy of theta-burst rTMS in patients with major depression. Patients will be randomized to receive ether left-sided intermittent theta-burst rTMS or rigt-sided continuous theta-burst rTMS or sham theta-burst rTMS over two weeks period with an option for an additional two weeks period, depending on treatment response. Clinical assessments will be performed weekly by the Hamilton depression rating scale. In addition, standard neurophysiological assessment of cortical excitability will be done.


Eligibility Criteria:
Inclusion Criteria:

* Major depressive episode (DSM IV criteria).
* Informed consent.
* Age: 18-70.

Exclusion Criteria:

* Suicidality
* Psychosis
* Pacemaker
* Cardiac arrythmia
* seizure disorder
* implantable metal devices
* PNS and CNS disorders
* any other contraindications as specified in safety guidelines for rTMS (Wassermenn, 1998).
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation

The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first.

This study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participants, the healthcare providers (HCP) involved in their care or the care of their infants, if applicable, and Albireo pharmacovigilance.

Study start date is either start of data collection or first patient enrolled whatever occurs earlier.

The surveillance program is strictly observational; the schedule of office visits and all treatment regimens are determined by HCPs. Only data that are routinely documented in patients' medical records as part of usual care will be collected.

No additional laboratory tests or HCP assessments will be required as part of this surveillance program.


Eligibility Criteria:
Inclusion Criteria:

* Exposure to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first).
* Informed consent or IRB-/EC-approved waiver of informed consent (not applicable if reported by Albireo PV according to usual pharmacovigilance practices)

Exclusion Criteria:

* Refusal to provide informed consent, if required
Electro-clinical Features and Functional Connectivity Analysis in SYN1 Gene Mutation-related Epilepsy

SYN1 gene mutation is an X-linked gene mutation that causes numerous pathological manifestations such as seizures and neurodevelopmental disorders. A few descriptions of this disease have been published in the last decade, but the electro-clinical features of epilepsy are still largely unknown. No analysis of electroencephalographic connectivity has yet been performed. The aim of this study is to perform a detailed electro-clinical seizure analysis and electroencephalographic analysis in patients with a SYN1 gene mutation, in an attempt to identify a characteristic pattern that would allow earlier diagnosis and better understanding and management of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Cases : SYN1 gene mutation, available electroencephalographic and clinical data.
* Controls : older than 12 years at the moment of the electroencephalogram recording, electroencephalogram considered as normal, no neurological disease (particularly no epilepsy), no neuroimaging abnormality.

Exclusion Criteria:

- Controls : younger than 12 years at the moment of the electroencephalogram recording, electroencephalogram considered as abnormal, neurological disease (particularly epilepsy), neuroimaging abnormality.
RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy

The goal of this prospective randomized controlled trial is to compare the effectiveness of a home-based exercise protocol to formal physical therapy in patients who have been diagnosed with Achilles tendinopathy. The null hypothesis is that there will be no difference in the treatment outcomes between patients with Achilles tendinopathy who participate in a home-based program versus patients with Achilles tendinopathy who undergo formal physical therapy. Participants will be randomized to a 12-week home-based or formal physical therapy protocol and asked to complete brief outcomes surveys at their initial visit, and at 6 weeks, 12 weeks, 6 months, and 1 year after their initial visit.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age
* Must have a new diagnosis of Achilles tendinopathy that has presented with pain, thickening and tenderness at the mid substance of the Achilles tendon
* Symptoms present for at least 6 weeks

Exclusion Criteria:

* Patients with insertional Achilles pain or tenderness or concomitant plantar foot pain
* Patients who have had prior treatment with home eccentric stretching or physical therapy
* Patients who have prior diagnosis and treatment for Achilles tendinopathy
* Patients with history of injection (corticosteroid or sclerosing agents) to the Achilles tendon
* Patients with inflammatory arthritis
* Recent fluoroquinolone antibiotics (these agents are known to alter Achilles tendon physiology)
* Patients who have had prior foot or ankle surgery
* Individuals that do not speak English
* Bilateral disease
* Pregnant women
Comparison of Treximet & Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache

The primary objective is to determine whether inflammatory markers, such as C-Reactive Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP), or Substance P (SP) are reduced in patients having a migraine headache when treated with Imitrex or Treximet.

The secondary objective is to determine the effects of Imitrex and Treximet on C-Reactive Protein (CRP) in patients with active migraine headaches.

Migraine is a neurovascular process involving the brain and related structures. Neuroinflammatory substances such as CRP, CGRP, VIP, SP, and prostaglandins are liberated during the migraine. Elevation of these markers may be associated with other conditions which contain an inflammatory component such as coronary artery disease. VIP is an inflammation and pain transmission, and thus are markers of sensory nociceptive neurons.

During this study, the subjects will have the following inflammation markers analyzed: C-Reactive Protein (CRP), Calcitonin Gene-Related Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP), and Substance P (SP).

Eligibility Criteria:
Inclusion Criteria:

* Subject must sign an informed consent
* Males and females 18 - 65 years of age
* Have episodic migraine headaches
* Patients to satisfy the diagnosis of migraine headaches with aura, without aura or mixed
* Must be able to differentiate migraine headaches from other headaches
* Diagnosis of migraines for at least 6 months

Exclusion Criteria:

* Any medical condition, in the opinion of the investigator, that would make the subject unsuitable for enrollment
* Basilar or hemiplegic migraine headaches
* Pregnant woman or a nursing mother
* History (within 1 year) or current evidence of grug or alcohol abuse
* More than 15 migraine headaches per month
* Chronic daily headache
* Chronic use of NonSteroidalAntiInglammatoryDrugs
* Current participation in a research study or within the last 30 days
Unilateral Sequential Sympathectomy for Palmar Hyperhidrosis

Comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory hyperhidrosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering palmar hyperhidrosis

Exclusion Criteria:

* Patients with pleural adhesions, bleeding diathesis, local infection or previous operation for hyperhidrosis
An Observational Study to Assess Quality of Life and Satisfaction of Young Women (Aged 18-29) Following 6 (±1) Months Using Jaydess as Their Contraceptive Method

This is a cross-sectional, multicenter observational study to assess quality of life in young Spanish women (aged 18 to 29) who use Jaydess® as their contraceptive method. The study will be conducted in standard clinical practice conditions at the private gynecology clinics and during a single study visit.

Approximately 1,200 women who have been using the intrauterine delivery system (IUS) Jaydess® as their contraceptive method of choice for 6 (±1) months will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 29 years.
* Women who have been using Jaydess as their contraceptive method for 6 (±1) months.
* Women who have no comprehension, reading or writing challenges.
* Women who have given informed consent in writing.

Exclusion Criteria:

* Contraindication to the use of Jaydess.
* Prescription of Jaydess® for non-contraceptive medical reasons.
* Women who are considered to be unsuitable to take part in the study by the investigator (e.g., poor understanding of the study characteristics, uncooperative, etc.).
* Women who are currently taking part in any clinical trial.
Pro-active Genetic Testing in Kidney Transplant Patients

The purpose of this study is to determine the prevalence of genetic mutations that increase the risk of cancer and other medically actionable diseases in kidney transplant patients and to assess the impact of genetic testing on subsequent surveillance for cancer.


Eligibility Criteria:
Inclusion Criteria:

- Post transplant Kidney and Kidney Pancreas recipients.

Exclusion Criteria:

* Simultaneous Liver Kidney Transplant.
* Simultaneous Heart Kidney Transplant.
* Non renal transplant history.
Levator Resection with3 Point Fixation Versus 2 Point Fixation Tucking for Congenital Ptosis

to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation levator aponeurosis Tucking for Congenital Ptosis

Target population for the study is children under twelve years old presenting to ophthalmology clinic at Cairo university specialized pediatric hospital with congenital ptosis.

Patients will be randomly divided into two groups First group (A) will contain 20 patients who will undergo standard levator aponeurosis resection Second group (B) will contain 20 patient who will undergo two point fixation levator tucking

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral or bilateral simple isolated congenital ptosis.
2. Levator function more than 4mm

Exclusion Criteria:

1. Congenital ptosis associated with other ocular syndromes.
2. Recurrent ptosis following any attempt for repair.
3. Traumatic ptosis or acquired ptosis
4. -ve bell's phenomenon.
APremilast After FumaRic Acid Ester Treatment

Patient treatment preference and treatment satisfaction of physicians and patients comparing fumaric acid ester therapy with subsequent apremilast treatment


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥18 years
* Moderate to severe plaque-type psoriasis according to SmPC
* Phase I: Patients will be included once they are started on systemic fumaric acid esters (e.g. Fumaderm initial®) for the treatment of moderate-to-severe psoriasis vulgaris. Patients initiated on fumaric acid esters will be followed for a maximum of 24 weeks during phase I. Patients continued on fumaric acid esters beyond 24 weeks or switched to a therapy other than apremilast during or at the end of the 24-week phase I period will no longer be followed.
* Phase II: Patients switched to apremilast during or at the end of the 24-week phase I period will be included in phase II and followed for additional 32 weeks.
* Written informed consent

Exclusion Criteria:

* Prior treatment with biologics
* According to SmPC
* Participation in another clinical trial (parallel inclusion in the National psoriasis registry PsoBest is allowed)
Contingency Management for Smoking Abstinence With Adolescent Smokers

The primary objective of this research is to evaluate the effectiveness of this type of smoking cessation program by comparing a treatment group with a control group.

A secondary objective of this research is to explore relations between impulsive behavior and smoking-cessation success among treatment-seeking teens participating in a quit-smoking program.

Hypothesis 1. A greater proportion of the participants in the treatment condition will be verified as abstinent from smoking during the course of treatment than participants of the control condition.

Hypothesis 2. It is hypothesized that teens who do not successfully stop smoking (or who drop out of the treatment program) will be more impulsive (from measures taken just prior to treatment) than those who do successfully stop or significantly reduce rate of smoking.

In response to the need for treatments appropriate for adolescent smokers, this research (utilizing a two-group randomized-control design, n = 63 per group) will evaluate the effectiveness and efficacy of a new and innovative Internet-based contingency-management (CM) program for smoking abstinence with adolescent smokers. This program lasts for 42 days and involves a 21 day abstinence phase. For the treatment condition, participants are reinforced for breath samples that verify abstinence from smoking three times per day; however, for the control condition, participants are reinforced for timely breath samples regardless of abstinence status.

Because this CM program is Internet based it can be completed from home, which stands to be more viable as a treatment option for adolescent smokers than other treatments requiring frequent trips to a clinical facility. From preliminary work with adult and adolescent smokers, it is expected this treatment program will be highly effective in creating favorable changes in adolescent smoking behavior. This research will also involve eight monthly post-treatment follow-up sessions to determine long-term consistencies or changes in smoking behavior.

A secondary goal of this research is to explore pre-treatment assessments of different dimensions of impulsive behavior as predictors of treatment outcome. These behavioral assessments will provide highly detailed information about the specific behavioral styles of adolescent smokers who are unable to effectively change their smoking behavior during treatment. This information should provide new points of emphasis for treatment-program modifications to improve these programs to be more effective for adolescents most challenged in their efforts to quit or reduce smoking.

Eligibility Criteria:
Inclusion Criteria:

* Ages of 13-19
* Have a breath CO level of at least 10ppm
* Smoke at least 2 cigarettes per day
* Live in Columbus, OH area

Exclusion Criteria:

* Adolescents must be English-speaking
A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD).

The purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a VOE) that requires hospitalisation in adult and adolescent participants with SCD. The primary objective of this study is safety and will additionally evaluate pharmacokinetics (how crovalimab is processed by your body), pharmacodynamics (how your body reacts to crovalimab) and the preliminary efficacy of crovalimab compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>=40 kg.
* Confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (SCD genotype of sickle cell beta zero thalassemia).
* Vaccination against Neisseria Meningitidis serotypes A, C, W, and Y.
* Vaccinations against H. influenzae type B and S. pneumoniae.
* Participants vaccinated against SARS-CoV-2 are eligible, as long as it has been 3 days or more after inoculation with the vaccine.
* Diagnosis of an acute uncomplicated VOE, that requires admission to a hospital/acute medical facility and treatment with parenteral opioid analgesics.
* Adequate hepatic and renal function.
* Hemoglobin \>=5 grams/deciliter (g/dL)
* Platelet count \>=100,000/microliter (µL)
* Participants receiving SCD-directed therapies must be on a stable dose for \>=28 days.
* For female participants of childbearing potential, an agreement to remain abstinent or use contraception for 322 days (approximately 10.5 months) after the dose of study treatment.

Exclusion Criteria:

* More than 10 VOEs within the last 12 months prior to presentation, that have required a medical facility visit.
* Pain related to the current VOE ongoing for \>36 hours.
* Acute pain related to avascular necrosis, hepatic or splenic sequestration, or priapism.
* Pain atypical of an acute uncomplicated VOE.
* Evidence of or suspicion of ACS.
* Evidence or high suspicion of a severe systemic infection.
* Major surgery and/or hospitalization for any reason within 30 days.
* History of Neisseria meningitidis infection within 6 months prior.
* Known HIV infection with a documented CD4 count \<200 cells/µL.
* Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol.
* Immunized with a live attenuated vaccine within 30 days.
* History of hematopoietic stem cell transplant.
* Known or suspected hereditary complement deficiency.
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 322 days (approximately 10.5 months) after the study drug administration.
* Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within the prior 28 days or within five half-lives of that investigational product, whichever was greater.
SOMEBODY, a Social Media-based Eating Disorder Prevention Program

The purpose of this study is to develop and evaluate the feasibility, acceptability, and preliminary evidence of potential efficacy of a social-media based intervention to reduce risk factors for eating disorders in college women.

Previous research supports an association between specific aspects of social media use and increased eating pathology in correlational designs and that specific aspects of social media use cause increases in risk factors for eating disorders. The aim of the current project is to determine whether social media use can be altered to cause decreases in eating disorder risk factors. To accomplish this, college women will be recruited to participate in an open trial of a pilot program that adapts activities used within evidence-based eating disorder prevention programs to be used on social media platforms. The intervention is designed to target internalization of the thin ideal.

Eligibility Criteria:
Inclusion Criteria:

* female
* 18 to 25 years old
* score in the top 50th percentile for time spent on social media each day

Exclusion Criteria:

* male
* \<18 years or \>25 years old
* individuals who screen positive for a Diagnostic Statistical Manual-5 eating disorder on the Eating Disorder Diagnostic Scale