cyrilzakka/clinical-trials huggingface dataset:
Canalith Repositioning Procedure for BPPV in Primary Care

The purpose of this study is to see whether family doctors can treat benign paroxysmal positional vertigo (BPPV), or dizziness, using a procedure in the office. The study is looking at whether the treatment procedure cures the dizziness in more patients compared to patients that receive a "sham" or placebo procedure.

Many patients consult their family physicians because of dizziness. This is a disabling condition with serious consequences, especially in older people, as it may lead to falls and consequent fractures. One of the most common causes of dizziness is the so-called Benign Paroxysmal Positional Vertigo (BPPV). Patients with BPPV typically have severe vertigo provoked by a change in head position.

Benign Paroxysmal Positional Vertigo can now be accurately diagnosed, and distinguished form other dizziness producing conditions, in the physician's office and without any sophisticated diagnostics tools. Furthermore, it can be treated in the office setting by specific head positioning maneuvers (Canalith Repositioning Procedure) that are easy to learn and perform.

The Canalith Repositioning Procedure is currently almost exclusively performed in specialized settings by ear nose and throat (ENT) and Internal Medicine specialists. Its efficacy has been demonstrated in these settings. However, to-date no studies have been conducted in the primary care settings about the use and efficacy of the procedure, where the condition is first seen and assessed.

This is a randomized controlled trial to determine whether the procedure performed by family doctors cures dizziness.

Eligibility Criteria:
Inclusion Criteria:

* confirmed BPPV by positive Dix-Hallpike test

Exclusion Criteria:

* · Positive results of the Dix-Hallpike maneuver in both right and left head-hanging position;

  * Evidence of ongoing central nervous system disease (e.g., transient ischemic attack);
  * Otitis media;
  * Osteosclerosis;
  * Inability to tolerate a diagnostic Dix-Hallpike head-hanging maneuver;
  * Severe degenerative disc disease of cervical spine;
  * Severe and uncontrolled angina or hypertension
MGR001 / Advair Diskus Local Equivalence Study in Asthma

The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when administered by inhalation in adult asthma patients


Eligibility Criteria:
Key inclusion criteria include:

* Male or female subjects aged ≥18 years. Females may be of either childbearing or non-childbearing potential
* Physician diagnosed history of asthma for at least 12 weeks prior to screening
* pre-bronchodilator FEV1 60-85% at screening and other specified visits
* Post-bronchodilator reversibility \>/=12%
* Non-smokers and prior smokers with no history of smoking within the past 12 months prior to screening and a total smoking history of ≤10 pack-years
* Subjects able to discontinue asthma medications for the duration of the study and be maintained using albuterol as required
* Body mass index between 18-40 kg/m2 inclusive

Key exclusion criteria include:

* Presence or recent history of any other active, severe, progressive, and/or uncontrolled clinical disease, eg, poorly controlled Type 1 or 2 diabetes, seizure disorder or epilepsy, cerebrovascular accident, significant cardiac conduction abnormalities
* Respiratory conditions other than asthma and allergic rhinitis, including but not limited to: severe nasal polyposis or chronic rhinosinusitis, chronic obstructive pulmonary disease, bronchiectasis, Churg-Strauss Disease, lung resection, pulmonary fibrosis (primary or secondary), pulmonary hypertension, cystic fibrosis, sarcoidosis
* History of life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s)
* In patient hospitalization (not including ER visits) for an asthma exacerbation within the past year or during the run in period
* An asthma exacerbation requiring change in asthma therapy or oral/IV corticosteroids in the 3 months prior to screening
* History of seasonally unstable asthma where the season will coincide with the subject's participation in the study
* Use of prescription or non-prescription drugs, including beta blockers, tricyclic antidepressants, oral decongestants, benzodiazepines, digitalis, phenothiazines, monoamine oxidase inhibitors, etc
* Suspected hypersensitivity to the study drugs (including lactose) or severe milk protein allergy
* Clinically significant abnormalities in the screening ECG
* Evidence of alcohol or drug abuse or dependency within 6 months prior to screening
Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed HER2-positive primary breast cancer
* No evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neo-adjuvant or adjuvant)
* Completed neo-adjuvant chemotherapy prior to entry, if received
* At least 8 remaining cycles out of the total 18 planned 3-week cycles, if received IV Herceptin
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* History of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix, basal cell carcinoma, or other curatively treated malignancies of which the participant has been disease-free for at least 5 years
* Inadequate bone marrow function
* Impaired liver function
* Inadequate renal function
* Serious cardiovascular disease
* Human immunodeficiency virus or hepatitis B or C infection
* Prior maximum cumulative dose of doxorubicin greater than (\>) 360 milligrams per meter-squared (mg/m\^2) or epirubicin \>720 mg/m\^2 or equivalent
Reproducibility of Functional Shoulder Tests for the Return to Sport of Patients Operated on Previous Shoulder Instability

The aim of this study is to assess whether the indicators outcome of these tests discriminate between different populations. In particular to compare populations with shoulders without any history of injury with a population that had undergone a reduction in glenohumeral instability by the Latarjet technique.

The different objectives of this study are :

* To assess the intra- and intersessional reproducibility of functional shoulder tests
* To evaluate the influence of an anterior front stop using the Latarjet method on the functional profile of the shoulder compared to a healthy population.

Eligibility Criteria:
Inclusion Criteria:

Patient group :

* Male patient
* Between 18 and 30 years-old
* Occurrence of the injury requiring surgery during a sports activity
* Reduction of shoulder instability by the Latarjet technique
* Surgery performed by surgeon from Santy orthopedic center (Lyon)
* Patient's inclusion by decision of the surgeon during the 4 months postoperatively visit

Healthy volunteer group :

* Male patient
* Between 18 and 30 years-old
* Patient regularly practicing sport activity.

Both groups :

* Patient having signed an informed consent
* Affiliated subject or beneficiary of a social security scheme

Exclusion Criteria:

Patient group :

* Contra indication from surgeon
* Having another pathology in the upper limbs
* Present a constitutional hyperlaxity
* Have stiffness or recurrence of dislocation of the shoulder post-surgery

Healthy volunteer group :

* Report a history of upper extremity pain / injury within the past 12 months
* Report a history of orthopedic surgery on the upper limbs

All participants :

* Protected subject : adult under guardianship, guardianship or other legal protection, deprived of liberty by judicial or administrative decision
* pregnant woman, breastfeeding, parturient
Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced or metastatic Non-Small Cell Lung Cancer that cannot be cured with surgery, radiation, or combination thereof
* No more than 2 prior chemotherapy treatments including treatment with a platinum containing therapy
* Evidence of measurable disease by radiographic technique
* Male or Female, 18 years or older
* ECOG performance status of 0 or 1
* Resolution of all acute toxicities of prior therapies
* Adequate organ function

Exclusion Criteria:

* Major surgery or radiation therapy within 4 weeks
* Severe hemorrhage within 4 weeks
* Previous treatment with anti-angiogenesis agents
* Diagnosis of second malignancy within last five 5 years
* History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
* Known HIV
* Serious acute or chronic illness
* Current treatment on another clinical trial
* Pregnant or breastfeeding
Afatinib Genomic Landscape

The investigators propose to conduct a pilot feasibility study of single agent afatinib in patients with previously untreated metastatic EGFR (epidermal growth factor receptor) mutant adenocarcinoma of the lung (NSCLC = non-small cell lung cancer) with the sole purpose of characterizing the genomic landscape before afatinib and at the time of disease progression.

The current proposal will include exome and transcriptome sequencing from blood collected at baseline along with tumor samples obtained prior to starting afatinib and at the time of disease progression (a total of two tissue samples and one blood sample per patient). The samples will be collected via consent to the IRB (Institutional Review Board) approved banking study "Tissue and Blood Acquisition for Genomic Analysis and Collection of Health Information from Patients with Thoracic Malignancies, Suspected Thoracic Malignancies, or Mesothelioma".

If carried out successfully, the proposed strategy very likely will lead to a larger and adequately powered study (perhaps using whole genome sequencing) to understand fully evolving molecular changes due to clonal selection under treatment pressure. The pace of progress in the field of sequencing technology currently underway is only likely to accelerate in the near future yielding richer and highly content-rich information. Moreover, it is likely that genomic information from DNA sequencing and transcriptome will be supplemented by analyses of translatomes and proteomes.

Successful completion of the proposed study would enable future studies to fully harness the potential of emerging technologies to develop novel approaches to treat and even ideally prevent resistance to EGFR TKIs (tyrosine-kinase inhibitor) and other molecularly targeted therapies. This could serve as a template for other cancer types as well. Over time, this approach, broadly used, would create simultaneously, highly valuable annotated tumor specimens along with germ line DNA for high-throughput genomic studies to identify novel targets and their impact on the course of disease. Re-analyzing molecular changes in the tumor at the time of disease progression would likely be a new standard of care to guide salvage therapy.

Eligibility Criteria:
Inclusion Criteria/Exclusion Criteria:

* Diagnosis of metastatic stage IIIB/IV lung adenocarcinoma
* Presence of known sensitizing mutations in EGFR TK domain (exon 19 deletion and L858R)
* Absence of known resistant mutations in the EGFR TK domain (T790M)
* Consented to HRPO # 201305031 ("Tissue and Blood Acquisition for Genomic Analysis and Collection of Health Information from Patients with Thoracic Malignancies, Suspected Thoracic Malignancies, or Mesothelioma")
* No prior treatment for this malignancy
* No prior localized therapy to the biopsy site
* Planned treatment with standard of care afatinib at 40 mg QD (daily)
* Not pregnant or breastfeeding
* At least 18 years of age
Treatment Of Patients With Social Anxiety Disorder

GW876008 is a drug which may change mans reaction to stress, by decreasing the fear, physical and behavior symptoms that people with SocAD experience in social situations.


Eligibility Criteria:
Inclusion criteria:

* are diagnosed with generalized social anxiety disorder/social phobia.

Exclusion criteria:

* have a diagnosis of major depressive disorder
* have a history of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder.
Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development

Assessment of the association of maxillary expansion using a rapid palatal expansion, use of a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™ constitute the Yookid system™.

Obstructive Sleep Apnea syndrome (OSA) shows a 10% morbidity rate in children with a higher rate between the ages of 3 and 5. Generally speaking, its prevalence is underestimated. Furthermore, detecting OSA remains difficult due to its particular physiopathology. The decrease in nasopharyngeal airway dimensions is the most common etiology. This decrease is related to soft tissues as well as maxillomandibular abnormalities. The aim of the study is to show that reducing sleep apnea in children remains possible when inducing rapid palatal expansion and mandibular advancement using the Yookid™ system. The Yookid™ system associates a mandibular advancement appliance and repositioning of the patient during sleep.

Eligibility Criteria:
Inclusion Criteria:

* 5 to 7 year-old children
* Children with American Society of Anesthesiologists score (ASA) of 1 and 2
* Children with signs of OSA during examination and clinical exam
* Children with apnea-hypopnea index (AHI) from 1 to 5 (one to five sleep apnea / hour during PSG)
* Children with a class II division 1 angle malocclusion (at the canines level rotation center) and skeletal class II according to Delaire analysis

Exclusion Criteria:

* OSA associated to syndromic disorder and/or syndrome
* Body/Mass Index (BMI) \> 97ème percentile according to development curves (obese children)
* Central sleep apnea
* Respiratory allergy
* Previous ear, nose and throat (ENT) surgery
* Hypertrophic tonsils needing surgery
* Adenoid hypertrophy needing surgery
* Patients with ankyloglossia
Natural History Study of Pyruvate Dehydrogenase Deficiency

Pyruvate dehydrogenase (PDH) deficiency is one of the most common mitochondrial disorders. Patients with this genetic condition have difficulty utilising carbohydrates to produce energy and develop a combination of problems including seizures, poor balance, developmental delay, disability and have a reduced life expectancy. As for most mitochondrial disorders there is a lack of effective treatments. It is essential to understand the mechanisms underlying the disease in order to identify new treatments, and to understand the natural history of disease in order to prepare for clinical trials. To date, a natural history study of PDH deficiency has not been undertaken in the UK.

The researchers aim to undertake the first natural history study of PDH deficiency in the UK, to describe the spectrum of symptoms, genetics, management and outcomes in both children and adult patients.


Eligibility Criteria:
Inclusion Criteria:

1. Compatible clinical history AND

2a Enzymatic confirmation demonstrating reduced PDH activity in patient cells or muscle tissue OR

2b Confirmed pathogenic mutation in a gene associated with primary PDH deficiency (PDHA1, PDHB, PDHX, PDP1, DLAT) OR

2c First degree relative with a confirmed pathogenic mutation causing primary PDH deficiency

Exclusion Criteria:

Patients with 'secondary PDH deficiency' that is patients who meet criteria 1 and 2a but who have received a genetic diagnosis which confirms pathogenic variants in a gene not associated with primary PDH deficiency.
Feasibility Study of Presurgical Hormone Therapy (Anastrozole) in Breast Cancer Patients

1. Women with operable breast cancer with a 2-8 week preoperative waiting period will accept preoperative therapy trials and specifically taking a standard drug for breast cancer such as anastrozole in this study
2. Short term anastrozole treatment will induce measurable changes in biomarker levels (ER, PR, Her2, Ki67) within the tumor.
3. Degree of response to short term anastrozole varies with a) duration of treatment and b) breast cancer subtype (based on initial pre-treatment biomarker status)


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed postmenopausal women (Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL and estradiol \< 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.)
2. Confirmation of estrogen receptor positive invasive carcinoma on core biopsy
3. Patients whose cancers are palpable and have been deemed to be "operable" by the surgeon
4. Surgery is planned for the next 2-8 weeks.

Exclusion Criteria:

1. History of hormone replacement therapy in the last 6 months
2. Previous treatment by tamoxifen or aromatase inhibitor treatment in six months
3. Known hypersensitivity or contraindications to aromatase inhibitors
4. Known metastatic disease on presentation
5. Recurrent breast cancer
6. Inability to give informed consent
Breast Displacement and CT Radiation Dose

The primary hypothesis of this study is that breast displacement out of the direct plane of imaging during computed tomography (CT) of the abdomen will reduce effective radiation dose to the female breast. Secondary hypotheses are that image noise and artifacts will also be decreased.

Computed tomography (CT) is a significant source of medical-related radiation, and radiation-related cancer risk is increasingly recognized in the medical and lay community. One of the groups at greatest risk for radiation-induced malignancies is young females due to the radiosensitivity of female breast tissue. Breast tissue frequently lies within the imaging plane for CT of the abdomen with limited gain in diagnostic information. We propose displacing this breast tissue out of the direct imaging plane will decrease unnecessary radiation exposure and may also indirectly improve image quality.

A device called Chrysalis has been designed and received FDA approval for the purposes of displacing female breast tissue during CT.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for CT of the abdomen and pelvis at Harborview Medical Center
* able to provide written informed consent

Exclusion Criteria:

* Inability to provide written consent for self (minor, intubated, sedated, mentally incapacitated, in excessive physical distress)
* Chest or breast surgery within the previous 8 weeks
* Breast implants
* Open wounds to the chest wall
* Fractures of the ribs or spine within the previous 3 months
* Patients requiring oxygen therapy
* Mastectomy
* Breast radiation therapy
* Scarring to the breasts which would prevent displacement
* Claustrophobia is not an absolute exclusion criterion, but patient comfort will be a primary concern.
Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask

Supraglottic airway devices are important tools for airway management. Supraglottic airway devices have been introduced into brief surgical interventions because they are less invasive than intubation and safer than mask to maintain the patency of airway after induction of anesthesia. They are inserted via the oral route and can be used in emergency conditions when tracheal intubation and mask anesthesia are challenging.

Air Q intubating airway and Ambu Aura intubating laryngeal mask are two Supraglottic airway devices that are widely used.

Aim of the work is to compare Air-Q intubating laryngeal airway versus Ambu-Aura intubating laryngeal mask regarding sealing pressure and Fiberoptic intubation in class II obese patients.

Randomized comparative trial that will be performed in Kasr Al Ainy hospital, Cairo University, Cairo, Egypt.ASA II patients from 20 to 50 years of age, undergoing minor surgry were included in this study. 40 patients will be allocated into 2 equal groups using computerized software and enclosed in sealed opaque envelopes:

GQ ( n=20 ): Where Air-Q intubating laryngeal airway will be used for ventilation \& intubation through fiberoptic bronchoscope.

GA ( n=20 ): Where Ambu-Aura intubating laryngeal mask will be used for ventilation \& intubation through fiberoptic bronchscope.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years old.
* Sex: both genders.
* With American society of anaesthesiologists (ASA) physical activity II.
* Scheduled for elective surgery under general anaesthesia requiring endotracheal tube.
* Class II obese patients (BMI 34.9 - 39.9 kg/m2).
* Surgery: short time procedures ≥ 60 minutes, ≤ 120 minutes e.g.: breast surgery, elbow or foot surgery.

Exclusion Criteria:

* • Patient refusal.

  * Patients with any respiratory tract abnormalities as laryngeal masses \& facial deformities as fracture mandible.
  * Patients with risk of pulmonary aspiration as in full stomach patients.
  * Patients at risk of regurgitation of gastric content as in gastroesophageal reflux disease (GERD) and pregnant females.
  * Emergency operation.
  * Patients with obstructive sleep apnea.
  * Patients prepared for laparotomy or laparoscopic procedures.
  * Patients with risk of bleeding.