cyrilzakka/clinical-trials huggingface dataset:
Nasal Intubation Using the Blind Intubation Device

The purpose of this study is to determine whether nasal tracheal intubation using Blind Intubation Device is safe and effective in anesthetized patients with Mallampati class 3

The Blind Intubation Device (BID,Anhui Xiao Shan Hygienic Material Co.Ltd,Jixi County,China) is newly introduced for awake nasal intubation using a transillumination principle. For oral and maxillofacial surgery patients with anticipated difficult airways, the BID has a high rate of successful awake nasal intubation.Since the BID is more readily accessible,disposable and considerably less expensive,these advantages speak well for its use in China.However,to date,there is no study on its usage in anesthetized patients.The investigators hypothesized that a BID would be effective for nasal intubation in anesthetized patients with high Mallampati class and would result in fewer hemodynamic responses. To examine our hypothesis, the investigators would like to perform a prospective,randomized,controlled study to compare the effectiveness of the BID technique with a direct laryngoscope for nasal intubation in anesthetized patients with Mallampati class 3. The primary outcome measures are the hemodynamic changes during intubation. The investigators also would like to compare the intubation time required and associated airway complications in both groups as our second outcome.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-2
* Scheduled for oral and maxillofacial surgery under general anesthesia with nasotracheal intubation
* mallampati score 3

Exclusion Criteria:

* ASA physical status 3-4
* Patients with a history of intraoral,upper airway and neck surgeries
* Patients with a history of chronic respiratory, cardiovascular or any other systemic diseases
* morbid obesity
* neck scars
* mallampati score 4,inter-incisor distance\<3cm, thyromental distance\<6cm
* unstable cervical spine
* relevant drug allergy
Evaluation of Triclosan Coated Suture in Obstetrical Surgery

A prospective comparative randomized blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over an eight-month period between November 2020 and June 2021.

The aim of this study is to evaluate effectiveness of Triclosan coated suture use in obstetrical surgery.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with indicated cesarean delivery and who have signed a written consent.

Exclusion Criteria:

* Cases with incomplete follow up
* Breach of operative protocol
A Study of the Safety and Efficacy of Fabrazyme (Agalsidase Beta) as Compared to Placebo in Patients With Advanced Fabry Disease

People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps to breakdown and remove certain types of fatty substances called "glycolipids." These glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid ("globotriaosylceramide" or "GL-3") levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study will test the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients must provide written informed consent
* Patients must be at least 16 years old
* Patients must have a current diagnosis of Fabry disease and have a clinical presentation consistent of Fabry disease (decreased sweating, Fabry pain, angiokeratoma, etc.)
* Patients may not have received enzyme replacement therapy as a treatment for Fabry disease
* Patients must have a documented plasma a-galactosidase A (aGAL) activity of \< 1.5 nmol/hr/mL or a documented leukocyte aGAL activity of \< 4 nmol/hr/mg
* Patients must have one or more of the following: a serum creatinine measurement of 1.2 to 3 mg/dL (106.1 to 265 umol/L) OR estimated creatinine clearance \< 80 mL/min only if the patient's serum creatinine measurement is \< 1.2 mg/dL
* Female patients of childbearing potential must have a negative pregnancy test prior to each dosing and all female patients must use a medically accepted form of contraception

Exclusion Criteria:

* Patient has undergone or is currently scheduled for kidney transplantation or is currently on dialysis
* Patient has acute renal failure
* Patient has participated in a study employing an investigational drug within 30 days of study entry
* Patient has diabetes mellitus or presence of confounding renal disease
* Patient has a history of transient ischemic attack (TIA) or ischemic stroke within 3 months of study entry documented by mild-to-moderate neurological deficit
* Patient has critical coronary disease
* Patient has congestive heart failure
* Patient has severe residual neurological deficit that will confound the detection of new events as determined by an attending neurologist and/or Principal Investigator
* Patient is unwilling to comply with the requirements of the protocol or the patient has a medical condition, serious intercurrent illness, or extenuating circumstances that would significantly decrease study compliance, including prescribed follow-up
Individualized Comprehensive Rehabilitation Program in Chronic Knee Osteoarthritis

Knee osteoarthritis is a common condition characterized by pain and functional disability in older people. Prevalence increases with age and is more frequent in older women. The aim of this study was to assess the effects of an 8-weeks individualized comprehensive rehabilitation program with elastic bands on pain and functional disability in chronic knee osteoarthritis.

The main symptoms of knee osteoarthritis are pain and functional disability. These symptoms are caused by a progressive loss and deterioration of articular cartilage with reactive new bone formation at the joint's surface and margins involving articular cartilage, soft tissues, and bone damage. Many treatment programs have been developed, including medication with nonsteroidal anti-inflammatory drugs, physical modalities, and therapeutic exercises. It is hypothesized that an individualized comprehensive rehabilitation program uring 8 weeks would benefit women with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary symptomatic KOA according to the criteria of the American College of Rheumatology
* Women aged older than 65 years
* Pain predominantly over the last 3 months
* Kellgren and Lawrence score ≥2.

Exclusion Criteria:

* Ankle, hip or foot severe disorders
* Chronic back pain
* Alzheimer's disease, Parkinson's disease, motor neuron disorders.
* Diabetes mellitus
* Cardiac or respiratory insufficiency
* Inability to understand the procedure
Jacobson's Progressive Muscle Relaxation Technique on Children With Leukemia Undergoing Chemotherapy.

The goal of this clinical trial is to determine the effect of Jacobson's progressive muscle relaxation technique on anxiety and fatigue among children with leukemia undergoing chemotherapy. The main research hypotheses are;

* Children with leukemia who receive Jacobson's progressive muscle relaxation technique exhibit less anxiety than those who don't receive it.
* Children with leukemia who receive Jacobson's progressive muscle relaxation technique exhibit less fatigue than those who don't receive it.

Researchers will compare Jacobson's progressive muscle relaxation technique with standardized nursing care on a child's anxiety and fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with leukemia and received chemotherapy sessions.
* Age ranged from 7 to 15 years.

Exclusion Criteria:

* other disorders such as neurological diseases, cerebrovascular accidents, or mental illness.
An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients

To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the safety and efficacy of three different foscarnet maintenance therapy regimens. To determine the pharmacokinetics of intermittent administration of foscarnet with or without concomitant administration of zidovudine (AZT).


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
* Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic and/or hypertensive retinopathy.
* Known allergy to foscarnet.
* Recurrent episode of cytomegalovirus (CMV) retinitis.

Concurrent Medication:

Excluded:

* Nephrotoxic drugs.

Patients with the following are excluded:

* Recurrent episode of cytomegalovirus (CMV) retinitis.
* Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
* Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic, and/or hypertensive retinopathy.
* Known allergy to foscarnet.

Prior Medication:

Excluded:

* Ganciclovir for cytomegalovirus (CMV) retinitis.
* Foscarnet for CMV retinitis.

Patients with AIDS as defined by the CDC with manifest first episode cytomegalovirus (CMV) retinitis, as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography.

* Patients must be able to give informed consent.
Face Masks for Preventing Influenza Transmission

This work aims to measure the effectiveness of face mask worn by a patient with flu to avoid transmission to other persons in the household.

Background. Non pharmaceutical interventions, and in particular the wearing of face masks, could play a role in controlling the transmission of influenza in the early stages of the epidemic. In the French pandemic plan, surgical masks are recommended in contagious patients in wards. The effectiveness of such masks in preventing transmission of influenza A virus is unknown. Our project aims to assess the preventive efficacy and tolerance of surgical mask.

The primary objective is to measure the decrease of the number of secondary cases of flu in households where the index case will wear a surgical mask during its period of infectiousness (5 days), compared to households where the index case will not be subject to this intervention. Secondary objectives are: (1) to study the feasibility and tolerance of wearing a mask continuously during the period of viral shedding; (2) virological description of infection spreading among household contacts based on virological collections.

Eligibility Criteria:
Inclusion Criteria:

Patient seeking medical advice for:

* For symptoms less than 48 hours, combining fever\> = 37.8 ° C and a cough,
* during the period of a seasonal influenza epidemic (as defined by the Sentinel network)
* Older than 5 years
* And living in a household size between 3 to 8..
* The patient is the first case in the household (index patient). The patient has a positive rapid influenza A test.
* Informed consent.
* Affiliation to the social security.

Exclusion Criteria:

* When concomitant influenza cases are known in other householders
* When the patient is suffering from asthma or COPD (ongoing treatment):
* Hospitalization.
* Treatment by a neuraminidase inhibitor.
Wearing a Compression Garment for Patients With Hypermobility Type of Ehlers-Danlos Syndrome

The Ehlers-Danlos syndrome (EDS) is a rare genetic disease caused by an anomaly of the connective tissue. This syndrome has different forms. Hypermobility type is the most common. It is characterized by generalized joint hypermobility, associated with a chronic pain syndrome. Pains appear as the most frequent demonstration of this syndrome, the worst lived and the most crippling.

Faced with insufficient effect of drug treatment, other alternatives have been proposed to relieve these patients. Compression garments have been developed. They appear as medical devices targeted specifically for patients with hypermobility EDS type: in the symptomatic treatment of joint pain, in stabilizing joints by proprioceptive effect and of muscle globulization, and in the functional improvement.

The VETCOSED study is a quasi-experimental study of type "Before / After", monocentric, open. The study is realized in the Centre Médico-Chirurgical et de Réadaptation des Massues - Croix Rouge Française de Lyon, in association with the Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon. This study concerns about 40 patients with EDS hypermobility type, which will be followed for 8 weeks: 4 weeks during which they will wear a compression custom-made garment (short-sleeved vest CICATREX SED®), and 4 weeks during which they do not carry this garment.

The main objective is to demonstrate the effectiveness of compression garments in the EDS hypermobility type, especially in terms of symptomatic improvement joint pain.

The main outcomes expected of this study are:

* an improvement of the power and the peaks of couple of muscles rotators of shoulders.
* a decrease of the pains and the defects of articular stability of the shoulder
* an improvement of the quality of life and the functional independence of these patients


Eligibility Criteria:
Inclusion Criteria:

* Ehlers-Danlos syndrome hypermobility type confirmed the diagnosis of a geneticist
* with an instability of one or both shoulders, painful or considered invalidating by the patient (recurrent dislocation or subluxation : at least once / month or at least 12 times / year)
* having a joint hypermobility syndrome (abnormal mobility and in a non-physiological axis), with a Beighton score of greater than or equal to 5 of 9
* age greater than or equal to 18 years
* size greater than or equal to 1 m 40
* sufficient understanding of the French language in order to respond to self-report questionnaires

Exclusion Criteria:

* hyperalgic episode in progress
* unstable cardiac disease
* previous history of shoulder surgery
* severe skin lesions,
* pregnancy in progress
A "Window Trial" on Curcumin for Invasive Breast Cancer Primary Tumors

The purpose of this study is to determine whether oral administration of curcumin causes biological changes in primary tumors of breast cancer patients.

The purpose of this study is to determine whether oral administration of Curcuma longa extract causes biological changes related to apoptosis (DNA fragmentation) and cell proliferation (Ki67) in primary tumors of breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed invasive breast cancer (stages I, II, or III) with primary tumor(s) ≥ 1.0 cm on mammogram, ultrasound, MRI, or physical exam
2. 18 years of age or older
3. Subject must understand risks and benefits of the protocol and be able to give informed consent
4. Women of childbearing potential (WOCBP) must agree to use an approved form of birth control and to have a negative pregnancy test result within 14 days of registration. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes

   Approved forms of birth control:
   * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intra-vaginal, or transdermal)
   * progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)
   * intrauterine device, intrauterine hormone-releasing system
   * bilateral tubal occlusion/ligation
   * vasectomized partner
   * barrier contraception
   * sexual abstinence
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate hematologic and end organ function
7. Ability and capacity to comply with the study and follow-up procedures
8. Subjects must be scheduled for surgery at MUSC no less than 5 days from the planned start of day 1 and no more than 56 days from the planned start of day 1
9. At least 6 sections of unstained slides should be obtained. If sufficient slides or tissue is unavailable, the patient will be excluded from the trial

Exclusion Criteria:

1. Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy
2. Subjects with end-stage kidney disease and/or grade II liver dysfunction
3. Subjects who are pregnant or are lactating.
4. Subjects with bile duct obstruction, gallstones, predisposition to kidney stones(39), or gastrointestinal disorders such as stomach ulcers and hyperacidity disorders(40)
5. Subjects taking anti-coagulants or platelet inhibitors
6. Subjects taking drugs metabolized by CYP3A4, CYP1A2, and CYP2A6 enzymes
7. Subjects taking drugs that interact with P-glycoprotein (P-gp)
8. Subjects taking any of the medications listed under Other Herb-Drug interactions according to the Memorial Sloan Kettering Cancer Center in section 5.
Evaluation of the Preventing AIDS Through Live Movement and Sound (PALMS) Intervention for Minority Adolescents

The purpose of this program evaluation is to determine whether the Preventing AIDS Through Live Movement and Sound (PALMS) group-level intervention is effective in reducing HIV sex risk behaviors and increasing HIV testing of high-risk, incarcerated or adjudicated youth. The intent of this program is to support the evaluation of an existing intervention and provide feedback to the implementing organization for improved program effectiveness, not to conduct research.

Philadelphia Health Management Corporation (PHMC) is evaluating the Preventing AIDS Through Live Movement and Sound (PALMS) group-level intervention for high-risk, incarcerated or adjudicated youth. PALMS uses three theater-based sessions to increase knowledge about HIV/AIDS, increase HIV testing, and reduce risky sexual behavior through increased self-efficacy. The intervention is delivered by peers, and peers work with the intervention team to use evaluation results to improve the program. The evaluation will recruit male adolescents, aged 12 to 18 years, who are residing in juvenile justice or drug treatment facilities in Philadelphia. The evaluation design uses concurrent intervention (N=132) and comparison (N=132) groups. Data will be collected at baseline, immediate post-intervention, and at a 6-month post-intervention follow-up. The intent of this program is to support the evaluation of an existing intervention and provide feedback to the implementing organization for improved program effectiveness, not to conduct research.

Eligibility Criteria:
Inclusion Criteria:

* Male adolescents
* Between the ages of 12 and 18
* Receiving residential services at juvenile justice or drug treatment facilities
* African-American or Latino

Exclusion Criteria:

* Do not speak English
* Prior participation in PALMS intervention
* Female adolescents
Evaluating Girls Invest: A Mobile-Enabled Economic Empowerment Intervention for Girls to Reduce Risk for Partner Violence

The research aims to refine and evaluate Girls Invest, a newly developed economic empowerment intervention, to reduce economic and social risks associated with high rates of intimate partner violence (IPV) among adolescent girls in Ibadan, Nigeria. Girls Invest, initially developed and tested in the US, has been adapted for use in Nigeria via Phase I Wellspring support. Girls Invest participants complete gender equity and financial skills training modules via a mobile "app." Upon completion, each participant receives a financial resource of supporting girls' education/vocation (e.g., sewing machine, baking oven and pans, or funds to cover educational exams).

Adolescent girls residing in low-income communities in Nigeria experience high rates of IPV. Economic vulnerability contributes to these high rates of IPV in two major ways: 1) Economic vulnerability increases financial reliance on male partners; IPV is common in these partnerships with males and financial reliance on males decreases girls' ability to leave abusive partnerships. 2) Economic vulnerability can intersect with gender-based constraints (e.g. low prioritization of limited household resources for girls' education) and create low expectations of educational/career opportunities, which can shift girls' priorities away from the participants future training/education and increase intentions to find a male partner and start a family - thereby, increasing girls' risk for relying financially on male partners and risk for IPV. By promoting young females' financial knowledge as well as social/economic expectations and opportunities, Girls Invest seeks to decrease economic vulnerability, reduce girls' financial reliance on male partnerships, and reduce girls' risk for IPV.

First, the investigators aim to pilot Girls Invest with 20 adolescent females ages 15-19; assessments will include quantitative app-based surveys and focus group discussions to assess initial feasibility, acceptability and fidelity of implementation. The investigators will refine Girls Invest with consultation from a community advisory board. Second, to determine preliminary efficacy, the investigators will implement a 2-armed randomized-controlled trial, randomizing 240 adolescent girls ages 15-19 to the Girls Invest intervention or a wait-list control condition.

Girls Invest expands previous work on economic interventions for reducing IPV, and also employs innovative mobile technology methodologies. The proposed research has potential for high impact, particularly given the increase in economic vulnerability as a result of COVID-19, especially among girls who were already living in poverty prior to the pandemic, as well as the coinciding reports of increased IPV.

Eligibility Criteria:
Inclusion Criteria:

* Girls ages 15-19 in selected secondary classes of 16 schools in Ibadan

Exclusion Criteria:

* Girls under 15 and over 19 years of age
* Do not attend one of the selected secondary classes of 16 schools in Ibadan
A Study of Vorinostat in Patients With Solid Tumors (MK-0683-029)

The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral suberoylanilide hydroxamic acid in participants with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Participants with histologically or cytologically diagnosed solid tumor; no standard therapy available or participant has failed to respond to standard therapy

Exclusion Criteria:

* Participants with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks; previous treatment is 5 or more chemotherapeutic regimens.
* Any uncontrolled concomitant illness
* Are pregnant or breast-feeding
* Serious drug or food allergy
Acupuncture Versus Placebo Acupuncture During In Vitro Fertilization (IVF) Embryo Transfer

During IVF treatment, acupuncture at the time of embryo transfer may improve the pregnancy rate. This study aims to compare IVF pregnancy between two groups of patients that received either acupuncture or sham acupuncture (placebo)around embryo transfer

Acupuncture at the time of embryo transfer may improve the IVF pregnancy rate. This study aims to compare the IVF pregnancy between two groups of patients that undergo ivf/icsi treatment. The patients are randomized to receive either acupuncture or sham acupuncture (placebo)around embryo transfer

Eligibility Criteria:
Inclusion Criteria:

* infertility
* below 38 years
* ivf or icsi treatment
* fresh embryo transfer cycle
* no more than two earlier embryo transfers with "fresh" embryos
* embryo transfer on day 2 or 3 after oocyte aspiration, single or double embryo transfer

Exclusion Criteria:

* Frozen embryo transfer
* oocyte donation
* other "alternative" treatment during the cycle