cyrilzakka/clinical-trials huggingface dataset:
SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia

This trial will compare images obtained from a mobile colposcope with those obtained using a standard of care.

This trial will compare images obtained from a mobile colposcope with those obtained using a standard colposcope in women with abnormal pap smears. It is a non-inferiority trial. Blinded images will be evaluated be experts in colpsocopy and compared

Eligibility Criteria:
Inclusion Criteria: abnormal cervical cancer screening by pap smear of high risk HPV test -

Exclusion Criteria: no consent

-
Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?

The investigators propose a 3-treatment, placebo-controlled, double-dummy, double-blinded, randomized, crossover study in which single doses of placebo, will be compared to Fluticasone propionate (Flovent Diskus) 250 mcg and budesonide 400 mcg administered after allergen challenge, at cessation of the early allergic reaction (at 20% fall in FEV1 from post-allergen peak)

The aim of this pilot study is to evaluate whether fluticasone propionate affects the late allergic reaction after a single dose post-allergen challenge administered following cessation of the early allergic reaction.

Six subjects with mild asthma will be asked to volunteer for the study.The diagnosis of asthma will be and includes the presence of variable airflow limitation and AHR (PC20 methacholine \< 16 mg/mL). Subjects will be asked to participate if they demonstrate an allergen-induced early and late asthmatic response of at least 20% and 15% reduction in FEV1, respectively.

The study will consist of 4 periods, composed of a screening allergen period with 3 subsequent allergen challenge/treatment periods. Each period will be separated with a washout of at least 2 weeks. Subjects who demonstrate a dual asthmatic response in the screening period will be selected for randomization to treatment.

Eligibility Criteria:
Inclusion Criteria:

* mild asthma
* nonsmokers
* allergen-induced early and late asthmatic response

Exclusion Criteria:

* no medication other than infrequent ( \< twice weekly) inhaled beta2-agonists
* not be exposed to sensitizing allergens
* asthma exacerbation or respiratory tract infection in the past4 weeks
Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer

The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.

Inter-sphincteric resection (ISR) has become an increasingly popular optional surgical tool for the treatment of very low rectal cancer. Nowadays, preoperative criteria for Lap ISR were the patients whose diagnosed with clinical stages T1-2 and N0_1, which only a few patients with early stages can benefit from it. However, intra-operative radiotherapy with low energy X ray applied by Intrabeam is becoming an accepted radiotherapy technique for treatment of cancers. The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* those whom were preoperatively assessed to be in clinical stageT3 or has lymphatic metastasis by MRI or ultrasonic endoscopy;
* the lower edge of the tumor is away from the anal edge by less than 5 cm, or away from the dentate line by less than 3cm;
* in intra-operative separation, the lower edge of the tumor is below the plane of the levator ani muscle or the tumor is hard to separate;
* those in T4 stage and could be radically resected by intra-operative surgeon assessment;
* adequate preoperative sphincter function and continence; (vi)local spread restricted to the rectal wall or the IAS.
* absence of distant metastases.

Exclusion Criteria:

* clinical T4 tumors based on the Union for International Cancer Control UICC TNM classification (7th edition):
* infiltrating gross appearance of the tumors;
* poorly differentiated adenocarcinoma by biopsy specimens;
* a degree of preoperative incontinence.
Cerebral NIRS Profiles During Premedication for Neonatal Intubation

Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.

Primary outcome:

* Cerebral desaturation defined by a rScO2 delta \>20% from the baseline value (before premedication).
* Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .

Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.


Eligibility Criteria:
Inclusion Criteria:

* Corrected age \< 45 weeks of gestational age
* Currently hospitalized in a neonatal intensive care unit
* Requiring semi-urgent or elective intubation
* Equipped with a reliable and permeable IV line
* Parental consent

Exclusion Criteria:

* Lack of parental consent
* Parental refusal
* Sedative or anesthetic treatment in the previous 24 hours
* Hemodynamic compromise defined as mean blood pressure\< corrected GA and/or refill time \> 3 seconds
* Upper airway malformation
* Life-threatening situation requiring immediate intubation
* Inclusion in another trial not permitting any other participation
* Impossibility to establish venous access
* Any contra-indication to any experimental drug
* Skin lesions or burns of the forehead
Restless Legs Syndrome in Hemodialysis Patients

Restless legs syndrome (RLS) is defined as the spontaneous movement of the limbs (mainly legs) associated with unpleasant - painful sensation which is relieved by moving the affected limb. It is a common disorder in hemodialysis patients that leads to insomnia, impaired daytime functioning and quality of life. Symptoms of RLS are estimated to affect up to 25% of patients on dialysis when the international RLS diagnostic criteria are applied. Various pharmacological and non-pharmacological interventions have been used to treat primary RLS. However, the evidence for use of these interventions in people with End stage renal disease is not well established; and some have serious side effects. Because high oxidative stress has been implicated in the pathogenesis of RLS, investigators thought of evaluating the efficacy of vitamin C in reducing the severity of RLS symptoms in hemodialysis patients in this randomized, double-blind, placebo-controlled, two arm parallel trial. To note that only two studies were done worldwide that proved the efficacy of vitamin C in those patients.

The investigators are proposing to carry out a clinical trial. Around 100 stable hemodialysis adult patients at Makassed general hospital dialysis center and around 150 patients at Sahel general hospital and Zahraa hospital will be assessed according to the international RLS criteria. The data on individual, clinical and laboratory indices will be obtained from patients' recorded files and interviews. The investigators will compare the RLS group versus the non RLS group according to these factors to find the independently associated factors for RLS in dialysis patients.

Those who fulfill all four diagnostic criteria for RLS (confirmed independently by 2 neurologists) will be classified as "RLS positive" and will be asked to answer 10 questions on the international RLS study group (IRLSSG) rating scale. The IRLSSG rating scale was also used to evaluate the severity of RLS symptoms. These patients will be randomly allocated to two parallel groups to receive vitamin C (200 mg) or placebo for eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* patients under regular hemodialysis
* with no acute illness
* not hospitalized

Exclusion Criteria:

* Patients receiving:
* tricyclic antidepressants,
* selective serotonin reuptake inhibitors,
* dopamine antagonists,
* dopamine blocking,
* antiemetics,
* lithium,
* sedative antihistamines,
* Patients with a history of renal stones
Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot Wounds

The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000) for the treatment of chronic foot ulcers.

The Vaporox VHT1 study is a single arm study evaluating the efficacy of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000), as an adjunctive therapy for the treatment of chronic foot ulcers.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic, arterial, and venous foot ulcers as well as decubitus ulcers
* University of Texas Health Science Center classification: Grade 0, 1, and 2

Exclusion Criteria:

* Ulcers above the medial and lateral malleoli
* Etiology of cancer/neoplastic
* Etiology of collagen vascular disease
* Etiology of gangrene
* Etiology of osteomyelitis (Grade 3)
* Etiology of thermal burns
* Etiology of radiation injury
* Pregnancy
* Acute skin conditions
* Inadequate perfusion to support treatment
* Wounds where the end cannot be probed
* Wounds covered with petroleum based dressing
* Non-compliant patients
Phase 2b/3 Study of XAF5 Ointment for Steatoblepharon (Undereye Bags)

This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid steatoblepharon (undereye bags).


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe, bilateral lower eyelid steatoblepharon
* Must understand and provide informed consent
* Healthy facial skin

Exclusion Criteria:

* Pregnant or lactating women
* Clinically significant eye disease
* Best corrected visual acuity worse than 20/40 in either eye
* History of eye surgery in past 6 months
* History of lower eyelid surgery
Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects

Current therapies for Generalized Anxiety Disorder (GAD) have limited effectiveness. This study measures the efficacy of two different approaches to reducing anxiety and stress. One approach uses education, nutrition, exercise, and time management training, and another uses mindfulness meditation and yoga, which is taught as part of the Mindfulness-based stress reduction (MBSR) course, an 8-week manualized mindfulness intervention. We hypothesize that the two approaches will reduce anxiety in individuals with GAD in different ways. We will measure changes in stress hormones associated with these changes.


Eligibility Criteria:
Inclusion Criteria:

* Adults with generalized anxiety disorder
* medically healthy

Exclusion Criteria:

* substance abuse
* history of other psychiatric diagnoses such as psychosis, Obsessive Compulsive Disorder, PTSD
* use of certain types of psychotherapy, meditation training, yoga
* pregnant or lactating women
The Valve of Hyaluronic Binding Selection (PICSI) in Improving IVF Outcome

The investigators would like to assess whether selecting mature sperm using PICSI (selecting for sperm that bind hyaluronan) can optimize the IVF outcome of ICSI .

Aim

1. Primary outcome: To compare routine sperm selection using ICSI with sperm selection using PICSI plates in terms of implantation and fertilization rates for couples with male factor fertility
2. Secondary outcome : To compare live birth rates ,ongoing pregnancies and miscarriage rates for couples with male factor infertility using routine sperm selection with ICSI compared to using PICSI plates for sperm selection

Hypothesis:

Sperm selected for ICSI using (PICSI) will reveal increased implantation rates in comparison to sperm selected for conventional ICSI


Eligibility Criteria:
Inclusion Criteria:

* In order to participate in the study women must be 42 years old or younger and suffer from male factor infertility however they may have other causes for their infertility
* male factor infertility as defined by one or more of the following sperm parameters: \<20 Million /ml sperm concentration \< 30% normal morphology \< 3% Kruger morphology \< 50% motility sion Criteria:
Surgery Outcome Treated by Neo-adjuvant Combination of Oxaliplatin, Irinotecan, Folinic Acid and Fluorouracil (FOLFOXIRI) Regimen in Synchronous Liver Limited Metastasis Colorectal Cancer

This single arm study aims to evaluate the rate of conversion therapy in patients with unresectable liver-limited metastatic colorectal cancer (mCRC) using FOLFOXIRI neoadjuvant regimen and to assess the other outcome including the response rate, the survival rate and the safety profile.

Patients with liver-only metastases colorectal cancer could potentially be cured following surgical resection of metastases. Recent evidence suggest that a triplet chemotherapy regimen, FOLFOXIRI has been associated with higher R0 resection.

Eighty-nine eligible patients will be recruited at Cho Ray hospital in Vietnam. Patients will receive neoadjuvant FOLFOXIRI regimen every two weeks for up to 12 cycles and will undergo periodic imaging studies. The resectability of liver metastases will be assessed by a multidisciplinary team comprised of digestive surgeons, hepato-biliary surgeons, radiologists, and oncologists. This study will be helpful to establish a standard chemotherapy regimen for patients with liver-limited metastatic colorectal cancer. Moreover, this study will assess the surgical outcome, the response rate, the survival rate, the safety of triple drug chemotherapy and the association between conversion operable disease and various survival rate and patient's characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Patients from 18 to 75 years
* Able to give informed consent
* Have a histological adenocarcinoma diagnosis of colorectal cancer
* Resected or operable colorectal primary tumor
* Initially unresectable liver lesion considered by multidisciplinary team (MDT)
* World Health Organisation performance status (ECOG PS) 0, 1
* Adequate complete blood count, liver and renal function

Exclusion Criteria:

* Prior history of other active malignancies
* Unmeasurable lesion according to RECIST criteria v.1.1
* Recurrence of colorectal cancer
* Resection or ablation of liver lesion
* Distant metastases outside the liver
* Patients who have received prior chemotherapy with Oxaliplatin, Irinotecan, Capecitabine, 5-Fluoro-uracil.
* Concomitant uncontrollable medical status ie. symptomatic cardiac disease, infarction within 24 months, uncontrollable cardiac dysrhythmia, active infectious disease
* Pathology of the liver lesion except adenocarcinoma metastasis from colorectal cancer.
Phase I Trial of Periocular Topotecan in Retinoblastoma

This is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of periocular topotecan in patients with relapsed-resistant retinoblastoma.

Patients with bilateral retinoblastoma who have relapsed after attempts of conservative therapy with standard regimens such as carboplatin, etoposide, vincristine and external beam radiotherapy who face immediate enucleation of their single remaining eye are eligible for this protocol. Starting dose of topotecan will be 0.5 mg and dose escalation will be done by the accelerated titration method. Any Grade 3 ocular toxicity or grade 4 non ocular toxicity will be designed as the dose limiting toxicity. Grade 2 scleral toxicity will be considered for DLT. In case of grade 2 ocular toxicity or grade 3 systemic toxicity, the escalation dose will be 0.25 mg. Maximal dose will be 2 mg.

Eligibility Criteria:
Inclusion Criteria:

* Group Vb (Reese Ellsworth)
* Relapsed or progressed after carboplatin-based regimens and external beam radiotherapy
* Enucleation of the contralateral eye
* Normal renal and liver function

Exclusion Criteria:

* Presence of glaucoma, rubeosis iridis, anterior chamber extension
* Extraocular disease
* Adequate follow up impossible for social reasons
Electrical Stimulation With Different Currents and Electromagnetic Fields

Muscle strength is the amount of force generated by muscle contraction. It could be measured with an isometric dynamometer. This is a validated tool that could be used to measure Maximal Voluntary Isometric Contraction (MVIC) and Maximal Electrical Induced Contraction (MEIC). It is claimed that higher MEIC values will result in more force gained.

If a current is more tolerated it will be easier to achieve better MEIC values. Tolerance to an electrical stimulation could be measured with the Visual Analogue Scale (VAS). A ratio between Normalized MEIC / VAS is often used, implying that the current is better with a higher ratio.

Muscle fatigue is defined as a temporary loss or decrease in force-generating ability due to previous contractions. It is claimed that medium frequency neuromuscular electrical stimulation (NMES) generates more fatigue than low frequency currents.

Aussie is a medium-frequency alternating current, sinusoidal waveform, 1 KHz carrier frequency.

Neo-Russian is a medium-frequency current, rectangular biphasic symmetrical waveform, 2,5 KHz carrier frequency.

Rectangular Biphasic symmetrical (RBS) waveform is a type of Low Pulsed Current (LPC), claimed to be better than classical Russian Current.

Purpose:

As it has been claimed that LPC is better in MEIC and tolerance, the aim of this study is to compare it with two newer medium frequency currents in terms of MEIC, tolerance and fatigue.

Methods:

Thirty male subjects, right leg dominant, will receive randomly the 3 types of electrical stimulation. Before that, the MVIC will be measured for data normalization.

The MVIC and MEIC will be measured with an isometric dynamometer. In both measurements, subjects will be asked to perform three reps (5 sec work x 120 sec rest) and the best one will be used. Whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum.

To apply Aussie electrical stimulation, an Aussie Sport (Ibramed) will be used. To apply Neo-Russian, a Neurodyn III (Ibramed) will be used. To apply RBS, a Genesy (Globus) will be used.

The VAS will be used to assess tolerance to each treatment. One week later, the subjects will receive, randomly, a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest) of electrical stimulation with the three types of current. The data will be normalized with the MVIC and the reps equal or below 50 % of the first rep will be considered as a fatigue rep.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Male
* Right leg dominant
* Exercising regularly

Exclusion Criteria:

* History of injuries in the right leg
* Skin lesions
* Having a pacemaker
* Having a cardiovascular disease.
* Having a neurological disorder.
* Exercise 72 h before the procedure.
Endometrial and Myometrial Changes, With and Without Fibroids

fibroids are common among women in fertile age. the relation between fibroids and infertility is controversial. our goal is to claculate a ratio between uterine cavity - endometrium \& myometrium in normal uterine s and study the interference of the cavity in uterine s with fibroids.

phase 1-

1. retrospective measurments of uterine dimensions of 100 women with normal uterin
2. measurment of the above during different sycle days in the same woman. 30 women.

phase 2- retrospective measurments of 500 uterine dimensions of women with fibroids phase 3- the same for 400 uterine malformations

Eligibility Criteria:
Inclusion Criteria:

* women at IVF unit

Exclusion Criteria:

* inabilty to measure propperly the uterine dimensions
Improved Characterisation of Eclampsia

Eclampsia is a serious pregnancy complication.In our study we aim to characterize the clinical signs and symptoms that occur prior to the onset of eclampsia in a prospectively collected cohort.And Compare these characteristics to women with preeclampsia and healthy normal pregnancies to identify which features represent a unique clinical signature for eclampsia to form a simple predictive algorithm .

Eclampsia is a serious pregnancy complication that occurs when a pregnant woman - or new mother - experiences seizures associated with hypertension. These seizures pose a major risk to the life and the health of mothers and unborn babies. Signs or symptoms of severe preeclampsia are not always present or easy to recognise before a woman develops eclampsia. This is why it can be difficult to tell which women are likely to develop eclampsia before the first seizure occurs. If we can identify the features that are most common and unique to eclampsia, these could be used to develop a tool to help identify the women displaying signs or symptoms that occur prior to the onset of eclamptic seizures. This would mean that treatment to prevent seizures could be targeted to the right women and quickly administered before they become extremely unwell with this life-threatening complication.

Rates of eclampsia are far greater in low to middle income countries , with an estimated 16-69 cases of eclampsia per 10,000 livebirths. Thus, research conducted in LMIC settings allow for the prospective recruitment of a relatively large cohort of women with eclampsia. They are a useful target population to prospectively characterise the signs and symptoms preceding the disease. Such characterisation may yield a unique clinical signature for eclampsia and the development of a predictive algorithm.

Eligibility Criteria:
Inclusion Criteria:

1. Eclampsia:

   * Diagnosed as new onset generalized tonic colonic seizures or coma in pregnant women or women who have recently given birth.
   * Singleton pregnancies.
   * All gestational ages, including post-partum eclampsia
   * Enrolment to the study must occur within 7 days of an eclamptic episode Women must be coherent and able to provide informed consent prior to enrolment
2. Preeclampsia:

   ● Diagnosed as new onset of hypertension (\>140 mmHg systolic or \> 90 mmHg diastolic) after the 20th week of gestation and the coexistence of one or more of the following new onset conditions:Proteinuria ,Other maternal organ evolvement.
   * Singleton pregnancy.
   * Have not experience an eclamptic episode
3. Normotensive controls:

   * Healthy normotensive pregnant woman recruited from women seeking maternity services during the same or similar period
   * Matched 1:1 for each eclampsia and preeclampsia case
   * Matched by closest gestational age at recruitment to cases and parity

Exclusion Criteria:

* Women with multiple pregnancies.
* Women with seizures attributed to a diagnosis other than eclampsia such as; central nervous system infections, a history of seizures or epilepsy, medications and/or illicit drug use.
* Women unable to provide informed consent