cyrilzakka/clinical-trials huggingface dataset:
Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives

This prospective cohort evaluates the longitudinal profile of hemostatic biomarkers during the first 3 months after having stopped a combined oral contraceptive.

Women using a combined oral contraceptive (COC) and who have decided to stop it or switch it to a non-estrogenic contraceptive are included. At baseline, before the COC is stopped, and at multiple time points during the 3 months of follow-up, blood will be drawn to evaluate the hemostatic profile. Findings are compared with a control group of women without an estrogenic contraceptive, who are also followed for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* women
* 18-50 years
* current use (for at least 3 months) of an estrogenic contraceptive with the decision to stop it or replace it with a non-estrogenic contraceptive (estrogen group)
* no current use of an estrogenic contraceptive (control group)

Exclusion Criteria:

* personal history of VTE
* known thrombophilia
* recent medical event (hospitalization, surgery, cancer)
* pregnancy, post-partum period, current breastfeeding
Vit D and Post-extractive Bone Turnover

The aims of the study was to correlate the extent of the dimensional alveolar bone changes after tooth extraction and contextual guided bone regeneration with serum vit D levels in 14 patients. Moreover, at 4 months, a small bone sample was collected in order to correlate histological and immunohistochemical parameters of bone with vit D serum levels.

The study included 14 patients requiring tooth extraction and subsequent post-extraction bone regeneration with heterologous graft material of porcine origin. Four months after extraction, dental implants were placed, and insertion torque values (ITV) and implant stability quotients (ISQ) were recorded. During implant placement, a small bone sample was collected for histological analysis. The aim of the study was to analyze the correlation between serum vitamin D levels and post-extraction bone volume contraction, collagen type I (Col1A1), osteocalcin, osteopontin, runt-related transcription factor 2 (Runx2), ITV, ISQ, Newly Formed Bone Tissue (NFBT).

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult (≥ 18 years old)
* Patients willing to participate and to attend the planned follow-up visits

Exclusion Criteria:

* Absence of Type 1-Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism
* History of leukocyte dysfunction and deficiencies
* History of neoplastic disease requiring the use of radiation or chemotherapy
* History of renal failure
* Metabolic disorders such as osteoporosis and correlated vit D or antiresorptive medications assumption
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene
* History of uncontrolled endocrine disorders
* Alcoholism or any drug abuse
* History of immunodeficiency syndromes
* Smoker of 10 cig per day, cigar equivalents or tobacco chewers
* Conditions or circumstances which in the opinion of the investigator would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability
* Mucosa disease such as erosive lichen planus
* Residual post-extraction site with intact bone walls
* History of local irradiation therapy
* Persistent intraoral infection
Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

The purpose of this study is to evaluate the change in visual activity of ranibizumab to Photodynamic Therapy (PDT)in patients with choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis


Eligibility Criteria:
Inclusion Criteria:

* Subfoveal CNV due to presumed ocular histoplasmosis of less than 1 year duration
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age greater than or equal to 21 years of age
* CNV lesion of than \< 5400 microns in diameter
* Best corrected visual acuity of 20/40-20/320
* Birth control therapy for females of child-bearing potential

Exclusion Criteria:

* Subfoveal NCV due tp presumed ocular histoplasmosis for \> 1 year
* Pregnancy or lactation premenopausal women not using adequate contraception
* Prior enrollment in the study
* Any other condition that the Investigator believes would pose a significant hazard to the subject
* Participation in another simultaneous medical investigation or trial
* Participation in another trial or previous trial of ranibizumab or Avastin
* Any concurrent ocular condition in the study eye (cataract, diabetic retinopathy)that could require medical or surgical intervention or ifa allowed to progress, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period
* Previous panretinal photocoagulation
* Previous steroids or PDT in 3 months
* Previous participation in any studies of investigational drugs within 30 days preceding Day 0
* Prior participation in a Genentech ranibizumab clinical trial
* Previous treatment with intravitreally (in either eye) or intravenously administered Avastin within 3 months
* Previous use of Macugen in the study eye within 3 months
* Prior submacular surgery
Lower Limb Flexor Synergy Training in Chronic Stroke

This study evaluates whether a 4-week exercise training program focusing on lower limb flexors can improve lower limb motor function late after stroke. It is hypothesized that there would be significant improvements in gait and strength of the flexor muscles as a result of the training. It is also hypothesized that the training effects, if any, would be retained at 4 weeks after ending the training.

It is known that the muscles that flex the hip, knee, and ankle joints are responsible for bringing the leg up and forward during walking and for a successful recovery from a slip or trip. Many previous studies have focused on strengthening the lower limb muscles that support the body in standing and walking (the so-called anti-gravity extensor muscles) but the training targeting the lower limb flexors has rarely been emphasized in stroke rehabilitation. Therefore, it is the intent of this exploratory study to find out whether an exercise training program focusing on lower limb flexors can improve lower limb motor function late after stroke.

Ten participants with chronic stroke will be recruited. Their lower limb muscle function and walking performance will be assessed at baseline (2 to 3 times within the 2 weeks prior to starting the training), at the end of training, and 4 weeks later.

Each subject will perform biking exercises under supervision, 2-3 times per week for 4 weeks (30 minutes each). The bike pedals are moving backward at a preset speed regardless of user effort. With feet strapped to the pedals, the participant will be asked to activate the hip, knee, and ankle flexors simultaneously when the pedal is moving up and then relax. Heart rate (HR) will be monitored continuously using a fingertip pulse monitor to ensure the maximum training HR is no more than 75% of the subject's HR Reserve.

Eligibility Criteria:
Inclusion Criteria:

* Time post-stroke between 6 months and 3 years
* Able to walk with or without an assistive device for 7 m independently
* Abnormal flexor synergy in both hip and knee joints (score 1 or 2) on the Fugl-Meyer Assessment Lower Extremity section II: Volitional movement within synergies (Fugl-Meyer et al., 1975)
* Walk slower than 1 m/s
* Able to understand and follow simple instructions
* Agree not to participate in strength training or supervised physical therapy during and for at least 4 weeks after the completion of training
* Previous participation in the physical therapy program for stroke without experiencing excessive symptoms (shortness of breath, headache, prolonged fatigue)

Exclusion Criteria:

* Current symptomatic coronary artery disease or congestive heart failure
* History of myocardial infarction
* Uncontrolled hypertension (\>150/90 mm Hg)
* Lower limb fracture in the past 6 months
* Lower limb joint or muscular problems
* Acute or terminal illness
* Current participation in strength training or supervised physical therapy
Plyometric and Strength Training of Quadriceps and Hamstrings in Football Players

Football is a trendy sport in the world. A typical footballer runs more than 10 kilometers in an average game of 90 minutes. FIFA regulates the sport of football and the world cup is conducted every 4 years. Plyometric exercise training uses speed and different forced movements to build muscle power. Plyometrics training improves physical performance and the ability to do different activities. Strengthening exercises are designed to increase the strength of specific groups of muscles. Strengthening exercises overload the muscle until the point of muscle fatigue. By conducting the study, it will help us to make a better understanding that whether plyometrics or strength training is more effective so that we can cooperate it into the regular exercise of the football player so that their sports performance can be enhanced.

It will be a randomized clinical trial. It will be conducted at the Pakistan sports board and coaching center, Lahore. A sample of 40 athletes will be taken using convenient sampling. Athletes will be randomly allocated into two groups. Group A was given plyometrics and group B was given strengthening exercises. Athletes will be assessed using a 20m sprint test and an Illinois agility test before the initiation of the exercise regimen. Athletes will perform plyometrics 5 days a week and strength training twice a week for 6 weeks. Athletes will be reassessed after 6 weeks. Statistical analysis will be used to determine their effects with the help of the software SPSS 25.

Eligibility Criteria:
Inclusion Criteria:

* the age group of 15-30 years.
* Participants that are practicing five times a week
* Participants having experience of at least 1 year

Exclusion Criteria:

* Athletes with any musculoskeletal injuries;
* Athletes with any systemic illness;
* Novice football players
* Elite/ International players
Clinical Trial to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy

A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy and safety of adhesion barrier Mediclore versus no treatment in patients with total thyroidectomy


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male or female at least 20 years of age
* Patients without clinically significant lab
* Patients scheduled for thyroidectomy

Exclusion Criteria:

* Another clinical trials within 1 month
* History of previous surgery on same position
* Anticoagulant, general steroids within a week from surgery
* Immunosuppression or autoimmune disease
* General or local infection
* Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
* Incompatible medications
* History of drug or alcohol abuse, mental disorder
* Pregnant or lactating women and fertile women who is not using proper contraceptive method
* History of esophagus diseases
* Keloid symptoms
Envarsus XR Compared to Immediate Release Tacrolimus

The purpose of this study is to compare once-daily tacrolimus extended-release (Envarsus XR®) to twice-daily immediate release tacrolimus to find out if people taking tacrolimus extended release (Envarsus XR®) report fewer side effects, increased medication compliance and higher scores on quality of life assessments compared to people taking twice daily tacrolimus immediate release.

Despite improvement in short-term graft outcomes in organ transplant, transplant patients still have to take on complex medication regimens to achieve current results. Adherence to these complex medications is an important problem in light of the potential risk of acute and chronic rejection and the associated burden of increased hospitalization, cost, and diminished quality of life that results from missed doses and poor overall drug taking. Part of the diminished quality of life is also tied to the bothersome symptoms patient feel after transplant. Most patients experience symptoms that relate to either the overall transplant immunosuppression or medication specific side effects. In the BENEFIT and BENEFIT-EXT trials, \>60% of patients reported tiredness and lack of energy as an issue. Sleep problems, mood swings, restlessness, anxiety, depression, and concentration and memory difficulties appeared in approximately 50-60% of patients. In addition to these symptoms, \>38% patients also reported numerous others side effects that have been strongly associated with calcineurin-inhibitors such as tacrolimus that include dizziness, muscle cramps, trembling hands, tingling in hands and feet, and headache.

The investigators hypothesize that the use of once-daily Envarsus XR® could decrease some transplant- and tacrolimus-related adverse symptoms and potentially lead to improvement in quality of life and medication adherence when compared to twice-daily tacrolimus. In order to assess this hypothesis, a prospective, multi-center, randomized, open-label, pilot study to investigate medication adherence and patient reported symptom occurrence and interference with daily life comparing once-daily Envarsus XR® and twice-daily immediate release tacrolimus in adult renal transplant recipients (SIMPLE) is being proposed.

Eligibility Criteria:
Inclusion Criteria:

* Patient is an adult (18 years of age or older).
* Patient is a recipient of a deceased or living donor kidney transplant.
* Patient is able to comply with study procedures for the entire length of the study.
* Patient has been informed about the study survey and has signed an informed consent form.

Exclusion Criteria:

* Patient is unable or unwilling to complete study patient reported outcome questionnaires.
* Patient is currently receiving azathioprine
* Patient is currently receiving an mTOR inhibitor (sirolimus, everolimus)
* Patient is currently receiving an belatacept
* Patient has received investigational immunosuppression 1 month prior to transplant or post-transplant
* Patient is in a setting where a professional care taker is responsible for dispensing subject's medication.
Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

To determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) in women with breast cancer.

LAAVA 2 is a double blinded randomised placebo/sham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer. Patients will be randomly assigned in a 1:1 ratio to either active laser treatment or inactive "sham" laser treatment (setting of close to zero)

Participants will receive the 3 treatments approximately 4 weeks apart. Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment. At the twelve week follow up visit, after completion of study procedures, patients will be unblinded and those who received "sham" treatment will be allowed to crossover to "active" treatment if they wish.

Eligibility Criteria:
Inclusion Criteria:

* Women with a history of early breast cancer \>18 years of age
* At baseline patients must have at least one of five symptoms rated at ≥5 on a 10cm VAS scale. Symptoms include vulvo-vaginal itch, dryness, burning, dysuria and dyspareunia.
* Three groups of patients will qualify:
* Treatment induced premature menopause ≤45 years of age (eg secondary to chemotherapy or oophorectomy) for \>6 months
* Premenopausal women on GNRH (gonadotrophin releasing hormone) agonist + tamoxifen or an aromatase inhibitor
* Postmenopausal women on tamoxifen or an aromatase inhibitor
* Willingness to give written informed consent and willingness to comply with the study
* Up to date pap test / HPV (human papillomavirus) testing

Exclusion Criteria:

* Medical contraindication to the use of fractional ablative CO2 laser
* Use of oestrogen therapies (systemic or local) in the 6 weeks prior to study treatment
* Use of vaginal lubricants or moisturisers 14 days prior to the study treatment
* Active or recent genitourinary infections (\<30 days)
* Genital prolapse (grade III)
* Active or symptomatic vulvo-vaginal dermatological conditions (Lichen sclerosus, lichen planus, vulval psoriasis, Chron's disease, Hidradenitis Suppurativa, vulval dermatitis, candida, chronic vulvovaginal candidiasis, vulval intraepithelial neoplasia, genital warts)
* Inability to tolerate the use of fractional ablative CO2 laser (eg vaginismus)
CONCERTA Lab School Study

The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.

The hypothesis is that CONCERTA (methylphenidate HCl) is safe and effective in improving academic performance and behavior in children with ADHD when compared to placebo as demonstrated using specified study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled, crossover study evaluating the academic, behavioral and cognitive effects of CONCERTA (methylphenidate HCl) on older children with ADHD This means that all eligible children will receive treatment with methylphenidate HCl throughout the study (the titration and assessment periods) and inactive pill (placebo) on 1 of the 2 laboratory classroom days. On the other laboratory classroom day they will receive their regular dose of CONCERTA (methylphenidate HCl). The primary efficacy variable in this study is the Permanent Product Math Test (PERMP) attempted score. Secondary Measures include: SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham), tests of inattention, reading fluency and comprehension, and memory. Assessments will be completed during each of the laboratory assessment days (12.5 hours). Participants will be assessed for adverse events throughout the study. Patients will initiate treatment with oral CONCERTA (methylphenidate HCl) 18 mg at baseline and continue morning dosing with increases every 3 to 7 days until an optimal dose is achieved, up to the maximum of 54 mg/day. Eligible patients will remain in the study for a maximum of 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosis of all subtypes (except Not Otherwise Specified)
* Patients with total or subscale Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS-IV) scores \> =90th percentile relative to the general population of children by age and gender
* Patients currently receiving ADHD medication must be inadequately managed on their current stimulant dose and meet this criteria at the screening visit
* Ability to read and understand English
* Ability to attend school regularly

Exclusion Criteria:

* Estimated Full Scale IQ score of 80 or below, Severe Learning Disability
* History of or current, primary diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, Pervasive Developmental Disorder, Eating Disorder, Obsessive-Compulsive Disorder, Sleep Disorder, Major Depressive Disorder, Bipolar Disorder, Substance Use Disorder, Chronic Tic Disorder, personal or family history of Tourette's Syndrome
* Weight \< 3rd percentile for age
* History of hospitalization for treatment of a mood, anxiety, or psychotic disorder
* History of failed response to methylphenidate
Sodium-glucose Co-transporter 2 (SGLT2) Inhibitor Risk of Below-Knee Lower Extremity Amputation: A Retrospective Cohort Study Using a Large Claims Database in the United States

The purpose of the study is to estimate the incidence of below-knee lower extremity amputation in type 2 diabetes mellitus (T2DM) participants newly exposed to sodium-glucose co-transporter 2 inhibitors (SGLT2i)/ non-SGLT2i antihyperglycemic agents (AHA) overall and in the subgroup with high cardiovascular (CV) risk and to compare the hazards of below-knee lower extremity amputation in canagliflozin new users versus non-SGLT2i AHA new users.


Eligibility Criteria:
Inclusion Criteria:

* First exposure to the particular drug in person's history
* For the initial analysis, exposure start is between April 1, 2013 and January 31, 2015. For the ongoing repeat analysis per the protocol amendment, the study period ending date will vary depending on the time of each data extraction and analysis
* At least 365 days of observation time prior to index
* At least 1 condition occurrence of 'Type II diabetes' any time before or on index
* Exactly 0 condition occurrences of 'Type I diabetes' any time before or on index

Exclusion Criteria:

* Participants who had amputations prior to the index date were excluded.
Effectiveness of Using a Chatbot to Promote Adherence to Home Physiotherapy

A Chatbot oriented to virtually assist patients in a physiotherapy treatment has been designed and developed to interact with patients with musculoskeletal disorders in need for domiciliary rehabilitation. The tool has been designed to promote adherence to rehabilitation, what in turn may have an impact on clinical outcome. A randomized clinical trial involving patients undergoing total knee replacement has bee designed to determine the applicability of the proposal. The participants will be assigned into exerimental group (intervention with the software tool) or control group (standard care).


Eligibility Criteria:
Inclusion Criteria:

* Individuals on the waiting list for total knee replacement surgery
* Undergoing primary total knee replacement surgery
* Who have a personal smartphone
* Who have an instant messaging application installed
* Familiar with the use of such application (more than 3 accesses per week),

Exclusion Criteria:

* Evident cognitive state that prevents to understand care provider instructions
* Vestibular or central nervous system affection (e.g. stroke)
* Cannot read or write
* Do not understand Spanish language
* Not able to consent to participate
First in Man Trial of BI 113608

The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.

A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
The Effectiveness and Safety of Human Lumbar Puncture Assist Device (LPat)

The purpose of this study is to proof and investigate the effectiveness and safety of the invented device named "Human Lumbar Puncture Assist Device (LPat)" as an assist tool to be utilized to improve the success rate of performing lumbar puncture (LP), avoid side effects from multiple punctures, avoid excess radiation if the LP need to be done under fluoroscopy, and need to obtain none traumatic tap for better CSF analysis.

"Human Lumbar Puncture Assist Device (LPat)" was invented as an assist tool to be utilized to improve the success rate of performing lumbar puncture (LP), avoid side effects from multiple punctures, avoid excess radiation.

Eligibility Criteria:
Inclusion Criteria:

Patients age 12 years and older who need lumbar puncture (LP) for diagnostic purposes or patients already underwent LP but failed to obtain Cerebrospinal Fluids i.e. "Unsuccessful Tap"

Exclusion Criteria:

Patients younger than 12 years of age