cyrilzakka/clinical-trials huggingface dataset:
TEAS to Improve Outcome During Emergence From General Anesthesia After Robotic Surgery

This study is to observe whether transcutaneous electrical stimulation at specific acupoints could improve the quality of emergence in patients undergoing robotic laparoscopic gynecologic surgery.

During robotic laparoscopic gynecologic surgery, the patients are put in an extremely trendelenburg positon. And a long duration of this position could lead to delayed emergence or agitation. Stimulation at some acupoints were reported to improve homeostasis. In this study we tend to observe whether transcutaneous electrical stimulation at specific acupoints could improve the quality of emergence in patients undergoing robotic laparoscopic gynecologic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for robotic laparoscopic gynecologic surgery under general anesthesia
* Patients with written informed consent

Exclusion Criteria:

* Patients with difficulty in communication
* Patients with disease of central nervous system
Microdermabrasion for Acne

The purpose of this research project is to study the effect of micordermabrasion to try to improve the appearance of facial acne. The microdermabrasion machine is a hand-held device that directs pressurized aluminum oxide crystals at its target accompanied by a suction device. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well microdermabrasion works to improve the symptoms of acne.

Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. It is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options.

Microdermabrasion is a technique combining abrasion and negative pressure used primarily in the treatment of aging skin. It has also been proposed to improve acne presumably through a comedolytic effect. Negative pressure and abrasion may remove debris from follicular orifices that act as a nidus for acne lesions. Many physicians and spas use micordermabrasion as a treatment for acne, however, there has never been a randomized controlled trial to substantiate this practice.

We propose to evaluate the efficacy of microdermabrasion in the treatment of inflammatory acne. We will use the Bellamed microdermabrasion system produced by Bella products or the Altair Diamondtome System.

Eligibility Criteria:
Inclusion Criteria:

* Age 13 years or older of either gender and of any racial/ethnic group.
* Presence of clinically evident acne vulgaris of the facial skin.
* Subjects must be in generally good health.
* Subjects must be able and willing to comply with the requirements of the protocol.
* Subjects must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

Exclusion Criteria:

* Oral retinoid use within 6 months of entry into the study.
* Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
* Topical acne therapies (retinoids,antibiotics) within 2 weeks of entry into the study.
* Laser or superficial chemical peels at the sites to be treated within 3 months of entry into the study.
* Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated.
* Use of topical lipid absorbing substances (Clinac AC) within 2 weeks of entry into the study.
* Non-compliant subjects.
* Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
* Subjects using alcohol-based topical solutions or "exfoliating" agents within 2 weeks of entry into the study.
* Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
* Pregnant or nursing females.
The Effect of Simvastatin With Guided Bone Regeneration in Ridge Splitting and Simultaneously Implantation

Ridge split augmentation technique, with immediate implant placement, reduces the time of the treatment and the time of the final prosthetic reconstruction. Furthermore, compression of the bone increases its density. SMV is also found to promote osteogenic differentiation of bone marrow stem cells, suppress osteoclastic differentiation in bone tissue, and promotes osseointegration around implants in animal studies. The aim of this study is to compare surgical outcomes of the application of the alveolar ridge splitting (ARS) in combination with guided bone regeneration (GBR) using bone grafting and a barrier membrane, associated with immediate implant placement versus ARS in combination with the use of SMV with GBR using bone grafting and a barrier membrane, associated with immediate implant placement in patients with horizontally atrophic jaw bones.


Eligibility Criteria:
Inclusion Criteria:

* good general health at the time of surgery.
* at least 3 months of healing after tooth extraction.
* horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.

Exclusion Criteria:

* a vertical bone defect in the edentulous ridge.
* thick cortex in the labial/buccal with less cancellous bone inside
* obvious undercut on the labial/buccal side.
* uncontrolled periodontal conditions or other oral disorders.
* history of radiotherapy in the head and neck region.
* uncontrolled diabetes mellitus or other systematic disorders.
* smokers.
* Pregnancy.
* non-compliant patients.
* allergic reaction to the medications used.
Endocrine and Nutritional Assessment in B Thalassemia Major

B Thalassemia patients developed short stature and low weight in spite no evident endocrine abnormalities. One hypothesis is that they developed some degree of malnutrition,then the purpose of this study is to assess the nutritional status before nutritional intervention and after one year. Siblings of the patients will serve as a control group.

BMI, lipid and endocrine profile and leptin levels will be analysed in the study group only.

The nutritionist will advice the patients about calories requirement and intake, balance diet and follow up the patients during the study period of one year. No special medicaments or drug therapy will be provided as part of the study protocol

Eligibility Criteria:
Inclusion Criteria:

* All patients above age 5 ys treated in the clinic.
RCT Comparing 2 Radiotherapy HypoFractionation Schedules In Breast Cancer Patients

This is a prospective randomized Phase III trial to assess efficiency of two post mastectomy hypofractionation schedules (40 Gy /15 fx / 3 weeks, 5 days per week VS 28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy each week) as adjuvant radiotherapy in female patients with breast cancer after mastectomy.

166 patients of breast cancer patients after mastectomy ( 83 patients in each arm ) will be randomize into 2 hypofractionation arms : Arm A: 40 Gy /15 fx / 3 weeks, 5 days per week . Arm B: 28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy each week.

Simulation:

Patient will be simulated on CT simulator using breast wedge with angle. Serials will be taken every 2 mm from upper neck down to mid abdomen.

Contouring:

CTVcw, CTVRNI will be contoured through RTOG guidelines . PTV is added as 0.5 cm all around CTV. Lungs, Heart, brachial plexus, spinal cord, esophageus and thyroid will be contoured as OAR. (www.rtog.org/CoreLab/ContouringAtlases/BreastCancerAtlas.aspx).

D)Dose Constraints:

Arm A:

PTV EVAL ( CW) : V90 % ≥ 90 %. - V105 % ≤ 5% - V107%≤ 3 %. Ipsilateral lung: V20 less than 20-25% - V 8 less than 35%- Contra lateral lung: V4 less 10 %. Heart: V16 less than 5% (Lt sided). V20 less than 5% (Lt sided). V16 is 0%.(Rt sided) V20 is 0% (Rt sided). Mean heart dose ≤ 320-400 cGy. Contra lateral breast : D max≤ 240 cGy. V 144 cGy less than 5 %. SCV : V90 % ≥ 90 %. Thyroid : Mean dose less than 35 Gy - V30 less than 50 %.

Arm B:

PTV EVAL ( CW) : V90 %≥ 90 %. - V105 %≤ 5% - V107%≤ 2 %.

Ipsilateral lung: V30%less than 15 -20% - V15% less than 30-35% - V5 % less than 50-55%.

Contra lateral lung : V5 % less than 5%. Heart :V25 % less than 5 % - V5 % less than 30 - 35 %. Contra lateral breast: V3 % less than 5 %. SCV : V90 % ≥ 90 %.

Follow up:

A)Weekly follow up will be done during sessions then regular clinical exam every 3 months to assess :

1. Acute and late toxicity regarding pain, pulmonary toxicity, dysphagia, skin toxicity and lymphedema.Assessment will be done according to RTOG and CTCv.5.
2. Any local (chest wall) recurrence, regional (nodal) recurrence.

B)Annual Mammogram. C)Any another investigation (once indicated)

Eligibility Criteria:
Inclusion Criteria:

* Invasive carcinoma of the breast.
* Complete microscopic excision of primary tumour and axillary dissection or SLNB .
* Females with locally advanced breast cancer ( T3/T4 or N + or both ) who are candidate for neoadjvant chemotherapy regardless pathological stage after mastectomy.
* Patients with pathological stage (T3/ T4, +/- N+) or ( N+, any T) after upfront mastectomy.
* Able to comply with follow up.
* Written informed consent

Exclusion Criteria:

* Patients do not match with inclusion criteria.
* Collagen vascular disease, specifically systemic lupus, or scleroderma.
* Pregnancy or lactation at the time of radiotherapy.
Covid Vaccination in Liver Transplantation

The goal of this retrospective study is to evaluate the proportion of seroconversion after 2 doses mRNA anti-SARS-CoV2 vaccination in a cohort of high risk liver transplanted patients.

Seroprevalence is a secondary objective in order to identify seronegative patients with a history of COVID-19 (ie who lost antibodies) and seropositive patients with no history of COVID-19.

The hypothesis is that the degree of immunosuppression is determinant on the seroconversion rate and therefore, although at higher risk of severe forms of COVID-19, liver transplanted patients have a lower chance of being protected after vaccination.

Seroconversion rate in previously seronegative and with no history of COVID-19 liver transplanted patients is the main evaluation criteria.

The factors associated with the absence of seroconversion will be identified as a potential tool to better adapt the vaccination strategy in this population.

The rate of seroconversion after the 1st dose will also be evaluated. Safety of the 1st and 2nd injection will be reported as well as their value to predict seroconversion.

A control group of patients listed for transplantation will also be included both in the seroprevalence and the seroconversion analysis.

Persistance of the antibodies in long-term after transplantation and after transplantation for the patients who have been vaccinated before transplantation will also be reported.


Eligibility Criteria:
Inclusion criteria:

* Liver transplanted patients for \> 6 months after transplantation
* Listed cirrhotic patients
* Age \>18 years-old
* Consent for vaccination with mRNA vaccine

Exclusion criteria:

* Vaccination with non mRNA anti-SARS-CoV-2 vaccine
* Expressed opposition to participation to the study
Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.


Eligibility Criteria:
Inclusion Criteria:

* Ongoing participation in a Phase 2 \[LX1606.1-202-CS (NCT00853047), LX1606.1-203-CS (NCT01104415)\] or Phase 3 \[LX1606.1-301-CS (NCT01677910), LX1606.1-303-CS (NCT02063659)\] study
* Patients of childbearing potential must agree to use an adequate method of contraception (defined as having a failure rate of \<1% per year) during the study and for 12 weeks after the Follow-up visit.
* Ability and willingness to provide written informed consent

Exclusion Criteria:

* Major protocol violations or tolerability concerns in a Phase 2 (eg, LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 (eg, LX1606.1-301-CS, LX1606.1-303-CS) study
* Positive pregnancy test
* Presence of any clinically significant findings at entry for medical history, laboratory values, or physical examination
Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth (TryPla)

Currently the neonatal serum level of severals proteins can be used as an indicator of subsequent risk. For example, we plan to explore the neonatal kinetics of tryptase and other immune proteins as potential markers for the risk of postnatal complications, particularly in premature babies. However, today no study has shown whether the tryptase level in the newborn is a reflection of fetal synthesis alone, or that of the mother by possible transplacental passage. There is also no database that has defined normal values for tryptase in cord blood.

Our main objective is to determine the correlation between the level of maternal tryptase and that of the newborn in cord blood immediately after birth in order to estimate the transplacental passage of this molecule.

* The protocole will be explain to the family in delivery room, an information note will be given, and we will let the time to think about it.
* In a second time investigator will make the mother sign a consent, that participant could retract any time then.
* A blood sample will be taken from the mother within 2 hours of delivery, using a standard blood test.
* A sample will be taken from the infant by blood drawn from the umbilical cord (non-invasive and painless sample).
* A final blood sample from your newborn will be collected at the time of the Guthrie test (systematic screening for congenital diseases) already scheduled for the new born on the third day of life.
* This blood sample will be sent to the immunology laboratory of the Clermont-Ferrand University Hospital where specific biological assays will be carried out.
* Blood samples will be stored for future use in studies.
* A collection of data concerning the child, childbirth and the results of biological analyzes will be carried out. All data will be coded.
* A phone call will be made at 3 months of life, to review the state of the child's health during his first months of life.

Eligibility Criteria:
Inclusion Criteria:

* Mother-child couple
* Childbirth at the Clermont-Ferrand University Hospital.
* Affiliated to a social security system

Exclusion Criteria:

* Newborns whose holders of parental authority are protected by law (under guardianship, placed under the protection of justice)
* Newborns whose holders of parental authority are under the age of 18
* Fetal pathology, excluding prematurity.
* emergency caesarean section, because o life threatening condition for the fetus or the mother.
Total Intravenous Anaesthesia (TIVA) Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection

Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection

Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection regarding patient satisfaction and discharge time

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* signed informed consent
* elective transurethral prostata resection

Exclusion Criteria:

* ASA more than 3
* kidney disease, liver disease
* intolerance against bupivacaine, fentanyl, propofol og remifentanil
* chronic pulmonary disease
* dementia
A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)

The purpose of this study is to determine whether the investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Adults 50 years of age or older

Exclusion Criteria:

* Prior history of Herpes Zoster (shingles)
* Prior receipt of varicella or zoster vaccine
* Immunosuppressed
Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion

To compare between the efficacy of Paracetamol IV vs. Lornoxicam IV in pain relief following surgical abortion.

The medication will be given at the time of the procedure. Following the abortion, pain level will be evaluated.

Patients with medical indication for surgical abortion during first trimester will be divided to two groups. The study groups, the surgeons and the nurses will be blinded to one of the treatment arms.

Pain will be evaluated at fixed intervals following the abortion. Comparison in pain levels between the study groups will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgical abortion for first trimester pregnancy

Exclusion Criteria:

* Chronic pelvic pain
* Fibromyalgia
* Pelvic inflammatory disease
* Chronic renal failure, liver disease, peptic ulcer
* cervical stenosis
Muscle-in-vein Conduits for Digital Nerve Reconstruction

The actual study should provide a first direct comparison between results after reconstruction of sensory nerves of the hand using muscle-in-vein conduits to the standard methods of nerve transplantation and direct nerve suture.


Eligibility Criteria:
Inclusion Criteria:

complete digital nerve injuries, nerve reconstruction in the first 6 months post trauma

Exclusion Criteria:

total or subtotal amputations
Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.


Eligibility Criteria:
ELIGIBILITY:

Key Inclusion Criteria

* Documented B-cell Non-Hodgkin's Lymphoma
* Small lymphocytic lymphoma (ALC \< 5,000 cells/mm3)
* Marginal zone B-cell lymphoma (nodal, extranodal, or splenic types)
* Lymphoplasmacytic lymphoma
* Follicular center lymphoma, follicular

Disease documented to be refractory to a full-course of the most recent rituximab therapy (single agent or combination)

* At least 1 prior chemotherapy regimen and maximum of 3 prior chemotherapy regimens
* Bidimensionally measurable disease (by CT scan) with at least one lesion measuring ≥ 2.0 cm in a single dimension

Key Exclusion Criteria

* Patients who receive rituximab only as part of treatment with ibritumomab tiuxetan (Zevalin®) will not be eligible
* History of prior high dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible)
Cost Comparison Study of Darbepoetin Versus Epoetin Therapy to Treat Anemia in Hemodialysis Patients

The purpose of this study is to determine if there is a cost difference between darbepoetin alfa and epoetin alfa when used intravenously to treat anemia in hemodialysis patients.

Eligible hemodialysis patients who are currently receiving an erythropoiesis stimulating agent (ESA) who enrol and sign consent will be randomized on a 1:1 basis to either remain on epoetin alfa or switch to darbepoetin alfa as their anemia therapy. Patients will be dosed with the assigned drug using a study algorithm to maintain their hemoglobin (Hb) level within the currently recommended range (100-120 g/L). There will be an initial "run in" period of a minimum of six weeks to ensure the patient's hemoglobin is stable within the target range. The trial itself will run for a subsequent twelve months (active phase). Every effort will be made to ensure that Hb stays within the target range during the study period. The primary outcome will be the total cost of each ESA therapy over the twelve month active phase. Data including Hgb, iron indices and dosing, and clinical events will be obtained from electronic sources and from the attending physicians and/or the clinical pharmacist.

Eligibility Criteria:
Inclusion Criteria:

* age ≥19 years
* receiving in-center hemodialysis two or more times weekly
* anemia requiring erythropoiesis stimulating (ESA) agent therapy OR a hemoglobin(Hb)\<100g/L in the absence of other causes of anemia
* if female, must be using an approved method of contraception or judged unable to become pregnant
* able to give informed consent

Exclusion Criteria:

* acute kidney injury likely to resolve
* plans to change to peritoneal dialysis or home hemodialysis, or planned transplant from a living donor
* expected lifespan of less than six months due to a medical condition other than chronic kidney disease
* current hematologic condition that may cause anemia
* use of medications known to cause anemia
* use of any investigational drug or androgen within 90 days of screening
* significant bleeding within 30 days of screening
* red blood cell transfusion(s) within 30 days of screening
* documented or suspected pure red cell aplasia (PRCA)
* current iron deficiency
* documented allergy or intolerance to intravenous sodium ferric gluconate
* known or probable ESA resistance
* uncontrolled hypertension
* an intention to relocate to a different dialysis center in the near future
The Study of Short-range Antiviral Treatment During Pregnancy to Block Mother-to-child Transmission of Hepatitis B Virus and Withdrawal Time

Pregnant women carry high HBV DNA loads before delivery, which is the most important factor leading to mother-to-child transmission of HBV. Nucleoside analogue antiviral treatment during late pregnancy can significantly reduce the incidence of HBV MTCT, but security problems of using NA treatment during pregnancy has not been eliminated, Therefore, the aim of our study is to explore the effect of starting to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus(HBV MTCT).

HBV MTCT is the important reason to keep high prevalence of chronic HBV infection in China; high HBV DNA loads of Pregnant women before delivery is the most important factor resulting in mother-to-child transmission of HBV, therefore, how to drop HBV DNA levels of pregnant women before delivery to the level that can markedly decrease the rate of HBV MTCT on the base of HBIG combined hepatitis b vaccine injection for newborns, which is the most important method to improve HBV MTCT. Although Nucleoside analogue antiviral treatment during late pregnancy can dramatically reduce the rate of HBV MTCT, security problems of NA treatment during pregnancy has not been demonstrated, On account of the above problems, our study is to investigate the effect of starting to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus(HBV MTCT).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA \> 106 copies/ml

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus, HIV, etc.
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
* without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.