cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Bronchiectasis in COPD Patients

The identification of bronchiectasis in COPD has been defined as a different clinical COPD phenotype with greater symptomatic severity, more frequent chronic bronchial infection and exacerbations, and poor prognosis. A causal association has not yet been proven, but it is biologically plausible that COPD, and particularly the infective and exacerbator COPD phenotypes, could be the cause of bronchiectasis without any other known etiology, beyond any mere association or comorbidity.

The relationship between bronchiectasis and COPD has generated several questions. Is there any real increased prevalence of bronchiectasis in patients with COPD? Does the presence of bronchiectasis have an impact on the clinical characteristics, prognosis, or response to treatment in COPD, to the extent that it can be considered a distinct clinical phenotype? Should bronchiectasis in patients with COPD be seen as merely a comorbidity, or as a consequence of the disease's natural history? Is there a causal relationship between COPD and bronchiectasis? If this is the case, what are the pathophysiological mechanisms responsible for this relationship? And, finally, what is the role of chronic bronchial infection and exacerbations in this relationship?

Eligibility Criteria:
Inclusion Criteria:

* COPD patients based on GOLD 2019 criteria, stable or in exacerbation

Exclusion Criteria:

* acute pneumonia within 2 months
* malignancy
* congenital bronchiectasis ( immobile cilia syndrome, Kartagnar syndrome).
* Pregnancy
Methylprednisolone Addition in IVF Treatment of Infertile Couples

Hypothesis to be tested is whether follicular addition of Methylprednisolone can efficiently control late follicular progesterone rise during IVF treatment

The aim is to investigate any potential advantages of adding cortisone supplementation from the follicular phase onwards with regard to premature luteinization, oocyte quality, embryo quality and pregnancy outcome.

Eligibility Criteria:
Inclusion Criteria:

* less than 36, more than 10 antral follicles, FSH\<12

Exclusion Criteria:

* endometriosis stage III\&IV,
Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma

Glaucoma is one of the most common chronic pathologies and affects several millions patients. Among these, many have a poorly controlled glaucoma, damaging vision and leading to blindness.

One between principal reasons for poor glaucoma medication adherence is forgetfulness. To improve this issue, digital tools may benefit both ophthalmologists and patients by monitoring eye drop administration.


Eligibility Criteria:
Inclusion Criteria:

1. Patient \> 18 years old, both genders
2. Diagnosed with glaucoma, with controlled IOP (\<18mmHg)
3. Currently receiving a topical glaucoma treatment
4. Receiving a multitherapy a fixed combination of dorzolamide-timolol, preservative-free.
5. Patient willing to participate in the study.
6. Patient familiar with a smartphone and its applications

Exclusion Criteria:

1. Patient with any eye condition in addition to glaucoma requiring expected additional treatment
2. Patient with an ongoing or known history of ocular allergy and/or uveitis and/or viral infection and or ocular infection.
3. Patient who underwent intraocular surgery within the past 3 months or scheduled to undergo intraocular surgery within the next 3 months
4. Patient with best-correct visual acuity \<20/70 in the better seeing eye
5. Patient whose drop administration is performed by someone else
6. Alcohol addiction and/or heavy smoker, according to the investigator's judgement.
7. Patient inability to understand the study procedures or to give informed consent.
8. Non-compliant patient (e.g., not willing to attend a visit; way of life interfering with compliance).
9. Participation in this study at the same time as in another clinical study.
10. Patient being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee of the study sites or of the sponsor's company.
11. Patient not covered by the government health care scheme of the country in which he/she is living (if applicable).
12. Women of childbearing potential, pregnant or breastfeeding: Childbearing potential is defined as a woman who is not using a reliable method of contraception (oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, patch) or is not surgically sterilized.
Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B).

In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms:

* Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd)
* Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd)

Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment.

The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).

Eligibility Criteria:
Inclusion Criteria

* Documented diagnosis of multiple myeloma (MM) and measurable disease.
* Received 1 to 2 prior lines of anti-myeloma therapy.
* Must have documented disease progression during or after their last anti-myeloma regimen.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

Exclusion Criteria

* Any condition that confounds the ability to interpret data from the study.
* Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.
* Known central nervous system involvement with MM.
* Prior therapy with iberdomide.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Role of SNP and DIGOXIN Response in Atrial Fibrillation Patients

This study tested the hypothesis that response to digoxin is modulated by single Nucleotid Polymorphism (SNP):

* Multi Drug Resistance (MDR1) gene haplotypes and Solute carrier organic anion transporter family member 1B3 (SLCO1B3) gene Polymorphism and their role in the response to treatement.
* Aldosterone synthase (CYP11B2) gene and sodium channel, voltage-gated, type V alpha subunit gene (SCN5A) correlated with atrial fibrillation and their roles in response to digoxin.

The frequency distribution of single nucleotide polymorphisms (SNPs) and haplotypes in the ABCB1 and SLCO1B3 genes varies largely among populations. The aim of this study is to investigate the genomic variations influence of these two genes on the response to digoxin in Tunisian atrial fibrillation (AF) patients.

In fact human P-glycoprotein (P-gp) is encoded by the ABCB1 gene (MDR1), which is located on chromosomal region 7q21 and consists of 28 exons. To date, over 50 SNPs have been reported for this gene, some of them are known to be of functional relevance and can also alter the pharmacokinetics of substrate drugs. The aim of the current study is to analyze the ABCB1: C1236T (Gly412Gly), G2677\>T⁄A (Ala893Ser/ Thr) and C3435T (Il1145Ile) polymorphisms.

SLCO1B3 (OATP1B3) gene located on chromosomal region 12p12 is highly polymorphic. It is known to transport digoxin and expressed on the sinusoidal membranes of hepatocytes in humans. It mediated uptake into hepatocytes and may be an important step of the elimination of digoxin. In this study we will also investigate the relationship between two deletion polymorphisms (from -28 to -11 deletion) and (from-7 to -4 deletion), T334G (Ser112Ala) and G699A (Met233Ile) SNPs in the SLCO1B3gene and their role in response to digoxin.

Another way, progress in understanding molecular mechanisms in AF supports the idea that variability in response to drug therapy may reflect differences in disease mechanisms, it is entirely possible that response to AF is highly heterogeneous because the arrhythmia itself is not a single pathophysiologic entity.

Aldosterone synthase (CYP11B2) gene polymorphism was found to be correlated with atrial fibrillation (AF) risk. Moreover, the human cardiac sodium channel SCN5A is responsible for the fast depolarization upstroke of the cardiac action potential and serves as a molecular target for antiarrhythmic drugs. Mutations in the human cardiac sodium channel gene have been previously discovered in a spectrum of cardiac rhythm disorders. We hypothesized that the T-344C and H558R (His558Arg) SNPs in CYP11B2 and SCN5A gene which are associated with susceptibility to AF could be implicated in the variation of response to Digoxin.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 20 years
* Quick AF (heart rate\> 120 bpm) diagnosed by ECG

Exclusion Criteria:

* HR under 120 bpm
* Hemodynamically unstable patients
* Atrio-Ventricular-block (second or third degree)
* Ventricular rhythm disorder
* Acute coronary syndrome
* kidney failure
* Hypokalimia
Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness

One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation.

One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) orally twice daily from the second day of their cycle through the seventh day and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets from the end of menstruation through ovulation. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation, follicle count, and pregnancy. Consequences, including miscarriage, ectopic pregnancy, and multiple pregnancies, were monitored.

Eligibility Criteria:
Inclusion Criteria:

* ages of 18 to 40
* patent tubes
* unexplained infertility
* regular menstrual cycle
* husband with normal sperm parameters

Exclusion Criteria:

* hypotension
* cardiovascular, renal and hepatic diseases
* uncontrolled diabetes mellitus
* anovulatory infertility
* abnormal thyroid functions
* ovarian cysts
* patients taking nitrates
* pelvic adhesions
* abnormal hormonal profile.
* hyperprolactinemia
* multiple uterine fibroids
* adenomyosis and endometriosis suspicion
Evaluation of Crestal Sinus Floor Elevation Using Densah Burs Via Surgical Guide and Simultaneous Implant Placement

Ten patients with missing maxillary posterior teeth and maxillary sinus pneumatization in this study .the floor of maxillary sinus will be elevated using densah drill via surgical guide with simultaneous implant placement . patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.

purpose: This study aimed to evaluate maxillary sinus lifting using Densah burs assisted via surgical guide for simultaneous implant installation in atrophic posterior maxilla.

Materials and Methods: Ten patients with missing maxillary posterior teeth and maxillary sinus pneumatization in this study .the floor of maxillary sinus will be elevated using densah drill via surgical guide with simultaneous implant placement The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.

Preoperative evaluation: all patients will be examined clinically and radiographically using Panoramic view to assess the condition of upper and lower jaws mainly bony tissues and Cone beam CT(CBCT) scan to identify the quality and quantity (width, length) of the bone at the surgical site, design and fabricate surgical guide.

Surgical procedure:, a crestal incision will be made and a full thickness mucoperiosteal flap will be elevated, surgical guide will be prepared and adapted to ridge, supported to the neighboring teeth. and the densah drill will be used as the same manner by manufacture ,bone graft will be inserted at the osteotomy site and the implant will be inserted at this site and using osstell ISQ scale to measure implant primary stability. Flap will be sutured using 3-0 vicryl sutures.

Postoperative evaluation: All patients will be followed up at the first week, one month and 4 months postoperatively both clinically if there is pain ,edema , inflamation and radiographically CBCT immediate and 4 months to Detect the amount of elevation will be measured by drawing a tangential line against the implant surface, just above the sinus floor, a measurement will be taken up to the point where the graft material will be seen covering the top of the implant apex ,Detect density of bone graft

Eligibility Criteria:
Inclusion Criteria:

1. Residual bone ridge below the sinus floor ≥ 4 mm ≤6mm.
2. Patients should have no sinus pathology detected radiographically.
3. Inter arch space≥8mm.

Exclusion Criteria:

1. patients with any systemic diseases that affect osseointegration rates.
2. Heavy smokers (\>14 cigarettes per day) .
3. pathological lesions in the maxillary sinus.
Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema

Lipedema is a disease characterized by bilateral abnormal fat deposition in the upper and lower extremities. Pain is a common symptom in lipedema.Vitamin D plays an important role in chronic pain. Vitamin B have analgesic role in some neuropathic pain conditions.This study aimedto evaluate the relationship between vitamin D and vitamin B12 levels and neuropathic pain in lipedema.

In this cross sectional study 200 lipedema patients will beincluded. According to painDETECT questionnaire scores of cases with lipedema patients will be divided into two groups;An overall score of \> 13 likely or possible neuropathic pain (group 1) and \<13 unlikely NP (group 2). Patients' age, gender, comorbid diseases and laboratory values (25 OH vitamin D and vitamin B12 levels) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* The patients diagnosed byan experienced physical medicine and rehabilitation specialist for the diagnosis of lipedema

Exclusion Criteria:

* individuals who did not have 25(OH)D and B12 values in the past 6 months,
* those with a history of gastrectomy or bypass surgery,
* those consuming a vegetarian diet, those with lymphedema or chronic venous insufficiency, endocrine diseases, rheumatic diseases, malignancy, neurological diseases, and musculoskeletaldiseases that can be related to lower extremity neuropathic or nociceptivepain.
Impact de la Marge de résection Sur la Survie à Long Terme et le Taux de récidive Des Patients Atteints de Cancers Colorectaux opérés au CHUS Entre 2006 et 2016 Pour Des métastases hépatiques

We retrospectively looks at the impact of the margin status and its size in mm on the recurrence rate in colo-rectal liver metastasis surgery.

Main objective : evaluation the margin status (\<1mm, 1-4mm, 5-9mm, \>10mm) on the survival and recurrence in colo-rectal liver metastases surgery.

Secondary objectives include :

Evaluate potentiel effects of neo-adjuvant chemotherapy, portal embolisation, and evaluate potentiel bias such as size and number of liver metastases, TNM status of original tumor, timing between primary and metastasis, and extra-hepatic disease.

Methods :

A retrospective cohort study is built where all patients undergoing liver surgery for colorectal liver metastases between 2011 and 2015 are analysed. Subjects are separated in groups according to their margin status. The local and distal recurrence rates are measured and well as survival. Data is obtained through our hospital data management system. Inclusion criterias include age over 18, primary colorectal cancer metastatic to the liver, having undergone surgery between 2011 and 2015, available pathology reports with required data, available radiologic follow-up. Exclusion criterias include repeat liver resection, documented grossly positive margins (R2 resection), and unavailable pathologic information and follow-up. Using survival as primary outcome (Kaplan Meier) and considering 25% potential loss to follow-up, we calculated a sample size. Since this a retrospective study, no patient is directly contacted. Data will is handled by the surgery resident responsible for the project as well as by research assistants. Statistical analysis are performed accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Primary colorectal cancer with liver metastasis
* Undergone liver surgery at our center between 2011 and 2015
* Pathological reports with margin status available (or specimen still available for measurement)

Exclusion Criteria:

* Repeat liver resection No tissu or incomplete pathological information
The ATLET Study: Can Subjects With Incomplete Spinal Cord Injury Learn to Walk?

The ATLET study will assess the effect of manual or robotic body-weight supported locomotor training of patients with stable motor incomplete spinal cord injury (SCI) on gait and overall ADL function as well as on estimated health care costs.

There are approximately 100 new cases of spinal cord injuries (SCI) each year in Norway. Most of the SCI occur after traumatic accidents among young people and adults during the time of their productive life. Loss of walking and standing ability restricts their independent mobility and autonomy and severely impacts their quality of life.

The study has two arms: 1) manual locomotor training (Tromsø) and 2) robot assisted training (Oslo). Each study arm has 30 patients, randomized to receive standard care or intervention. The intervention group receives 60 days of intensive locomotor training over 6 months. Single-blind, before/after evaluation of effect will be performed at Sunnaas hospital using a standardized set of evaluation tools.

Eligibility Criteria:
Inclusion Criteria:

* Motor incomplete SCI grade AIS-C or -D
* Age: 18 - 70 years
* Body mass index of \<30
* Wheelchair dependent
* At least 2 years since time of injury
* Cognitively unaffected and motivated for locomotor training
* Lives within driving distance of Oslo (\< 70 km), if considered for the outpatient arm of the study.

Exclusion Criteria:

* Complete SCI grade AIS-A or -B
* Cognitively reduced
* BMI ≥ 30
* Age: under 18 years or above 71 years
* Spasms and contractures which can prevent locomotor training
* Changes in use of spasm reducing medication during intervention
* Significant osteoporosis in spine and/or joints
* Pregnancy (adequate contraceptive use is required of women in fertile age)
* Physical limitations for the use of the robotic orthosis
* Participation in other intensive training programs
* Those who live 70 or more kilometers from the Oslo training center, will be enrolled in the Tromso arm of the study.
* Other medical condition which can interfere with the training protocol
* Previous knee- or hip replacement
Protective Effects of EPI-743 on Noise-Induced Hearing Loss

If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults ages 18-30
* Abstention from use of Idebenone, CoQ10, Vitamin E and foods or beverages at least 30 days prior to treatment initiation
* Non-smokers
* Abstention from alcohol from day 0 and throughout the duration of study
* Normal audiology exam
* Subject must be able to swallow size 0 capsules

Exclusion Criteria:

* Allergy to EPI-743 or sesame oil or nuts
* Any medical disordere that would prevent subject participation
* Any prescription meds other than for contraception or seasonal allergies
* Any significant patient medical history (cancer, cardiovascular, pulmonary, cognitive, ADHD, hx. of migraines, neurological, kidney)
* Fat malabsorption syndromes
* Anticoagulation thereapy within 30 days of enrollment
Uterine Rupture International Data Acquisition

Uterine rupture represents an uncommon event: it is is a life-threatening obstetric complication with high maternal and perinatal morbidity and mortality. Indeed, uterine rupture may cause catastrophic maternal and fetal complications (uterine hemorrhage, hysterectomy with consequent fertility loss, maternal and fetal death or cerebral palsy) which are hardly acceptable within the context of a natural event such as birth.

Uterine rupture can occur during pregnancy, early in labor or following a prolonged labor, most frequently near or at term and, rarely, during early to mid-pregnancy. Its prevalence ranges between 0.006% for women without previous cesarean section (CS) in the western countries, to 25% for women with obstructed labor in African countries.

Pregnancy after myomectomy or CS, vaginal delivery after cesarean sections (VBACs) and vaginal delivery after myomectomy are potentially "at risk" of uterine rupture.

Despite uterine rupture is widely considered a life-threatening condition, so far most of published data refer to case reports or very small case series. In this scenario, the "Uterine Rupture International Data Acquisition" study group would like to collect a large number of events, in order to identify the potential risk factors among different populations through a multivariate analysis.


Eligibility Criteria:
Inclusion Criteria:

* Women with uterine rupture occurred during pregnancy.

Exclusion Criteria:

* None.