cyrilzakka/clinical-trials huggingface dataset:
Development of a Risk Score to Predict the Vacuum Extraction Failure

Safe operative vaginal delivery requires a careful assessment of the clinical situation.

During the pushing efforts, the complexity of the delivery can lead to choose between an operative vaginal delivery attempt and a caesarean section straightaway. An emergency caesarean section for failed operative vaginal delivery is associated with a higher fetal and maternal morbidity, compared to a successful operative vaginal delivery and to a caesarean section straightaway.

The objective of this study was to develop a risk score of failed vacuum extraction leading to an emergency caesarean section.

This score could be an objective tool to help the obstetricians to choose between a vacuum extraction attempt and a caesarean section straightaway.

The investigators included patients who benefited from a vacuum extraction attempt in the Regional Teaching Hospital of Besançon (France) between January 2010 and December 2015. Patients were separated into two groups : the vacuum extraction failure group and the vacuum extraction success group.

The investigators selected maternal, fetal and labor characteristics which could influence success or failure of the vacuum extraction and compared them between the two groups.

The score was developed with the characteristics which significantly influence the vacuum extraction failure.

Safe operative vaginal delivery requires a careful assessment of the clinical situation.

During the pushing efforts, the complexity of the delivery can lead to choose between an operative vaginal delivery attempt and a caesarean section straightaway. An emergency caesarean section for failed operative vaginal delivery is associated with a higher fetal and maternal morbidity, compared to a successful operative vaginal delivery and to a caesarean section straightaway.

The objective of this study was to develop a risk score of failed vacuum extraction leading to an emergency caesarean section.

This score could be an objective tool to help the obstetricians to choose between a vacuum extraction attempt and a caesarean section straightaway.

The investigators included patients who benefited from a vacuum extraction attempt in the Regional Teaching Hospital of Besançon (France) between January 2010 and December 2015. Patients were separated into two groups : the vacuum extraction failure group and the vacuum extraction success group.

The investigators selected maternal, fetal and labor characteristics which could influence success or failure of the vacuum extraction and compared them between the two groups.

The score was developed with the characteristics which significantly influence the vacuum extraction failure.

Eligibility Criteria:
Inclusion Criteria:

* delivery in the Regional Teaching Hospital of Besançon (France) between January 2010 and December 2015
* from 37 weeks of amenorrhea
* cephalic presentation
* epidural anesthesia
* vacuum extraction attempt (failure or success)
The Effect of Thoracic Mobilization in Individuals With Subacromial Pain Syndrome

The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome.

Subacromial pain syndrome (SAPS) is the most common shoulder problem and accounts for 44%-65% of all shoulder problems. Repetitive compression of the rotator cuff tendons as they pass through the subacromial space affects shoulder function along with pain.

Studies have shown that scapular kinematics are affected in individuals with subacromial pain syndrome. In addition to increased scapular internal rotation, scapular upward rotation and posterior tilt during elevation are decreased in these individuals. These kinematic changes have been associated with decreased activation of the middle and lower trapezius and serratus anterior muscles and excessive upper trapezius activation. This change in scapular kinematics causes narrowing of the subacromial space and repeated traumatization of the rotator cuff muscles passing through it. In addition, kyphotic posture in the thoracic region (insufficient extension of the thoracic vertebrae) negatively affects scapular kinematics. Kyphotic posture has been shown to be associated with subacromial pain syndrome by causing anterior tilt, downward rotation and protraction in the scapula.

Exercise and mobilization applications are frequently applied in subacromial pain syndrome. Strengthening the muscles around the shoulder and scapula, increasing glenohumeral and scapulothoracic joint mobility, and stretching the posterior capsule are frequently applied to reduce pain and increase function. Studies on increasing thoracic mobilization are limited in number. In these studies, the acute effects of thoracic manipulation applications on pain, normal joint motion and functional activity level were examined in individuals with subacromial pain syndrome. There is only one pilot study that examined the effect of mobilization applied to the thoracic region. The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Thoracic kyphosis angle \> 40°
* Full active shoulder abduction

Exclusion Criteria:

* Bilateral shoulder pain
* Rotator cuff tear
* Shoulder/cervical injury other than SAPS
* Surgery history
Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase

This Phase IV, dose escalation, within-patient controlled study of pharmacokinetics (PK), safety and tolerability compares a single dose administration of a large protein molecule without recombinant human hyaluronidase (rHuPH20) to a single dose administration of the large molecule with escalating doses of rHuPH20. The study hypothesizes that an optimal dose of rHuPH20 will increase the bioavailability of large molecule drug administration.

Sequential enrollment into four rHuPH20 dose cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females at least 18 years of age with RA treated with MTX who have been treated with:

   * co-injected large molecule protein for at least two cycles, and
   * have had stable disease with no symptom flares in the previous 30 days.
2. AST (SGOT) and ALT (SGPT) within normal range within 7 days prior to entry in the study.
3. Adequate venous access in at least one extremity.
4. A negative pregnancy test (if female of child-bearing potential) within 7 days prior to entry in the study.
5. Decision-making capacity.
6. Signed, written IRB-approved informed consent.

Exclusion Criteria:

1. Unacceptable toxicity to the large molecule protein, or contraindication to or other reason to not continue the large molecule protein per the package insert (e.g., active or latent tuberculosis, chronic or localized infections, or concurrent treatment with anakinra).
2. History of active tuberculosis, or known positive tuberculin skin test unless the patient has successfully completed a nine-month course of isoniazid therapy.
3. Concurrent use of any disease-modifying anti-rheumatic drug except the large molecule protein and MTX.
4. Any anticipation that the dose of the large molecule protein or MTX would be changed within 4 weeks following entry in the study.
5. Known allergy to hyaluronidase or any hyaluronidase product.
6. Known allergy to bee or vespid venom.
7. Contraindication to IV heparin lock or known hypersensitivity to heparin.
8. Edema, infection, or any other lower extremity or pelvic disorder that might affect subcutaneous absorption from the thigh.
9. Presence of any other medical condition that would present an unacceptable safety risk to the patient.
10. Participation in a study of any investigational drug or device within 30 days of enrollment in this study.
ClariFix Cryoablation Clinical Study

This is a single-arm pilot study designed to evaluate the feasibility of cryoablation in the nasal passageway, using the ClariFix device, to reduce the symptoms of chronic rhinitis.

This is a small, prospective, multicenter, single-arm, self-controlled interventional feasibility study to evaluation cryoablation in the nasal passage as a treatment for chronic rhinitis. The ClariFix device is FDA-cleared device with the intended use for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \>21 years of age
2. Subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion for \>3 months (rTNSS rating of 2 or 3)
3. Subject has signed IRB-approved informed consent form

Exclusion Criteria:

1. Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor
2. Subject has a septal perforation
3. Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose
4. Subject has had prior head or neck irradiation
5. Subject has active or chronic nasal or sinus infection
6. Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks
7. Subject has a history of dry nose symptoms
8. Subject is pregnant or lactating
9. Subject is participating in another clinical research study
10. Subject has an allergy or intolerance to anesthetic agent
11. Subject is an active smoker or has been a smoker within the last 6 months
12. Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk
3 Year Follow up Study of the IDEA Population

The aim of this study is to assess the efficiency of early treatment for ASD children 5 years after initial treatment.

The early treatment implemented was 12 hours per week of ESDM versus treatment as usual during 2 years. This was done as an RCT, called IDEA. Children will now be included in IDEA-2 SCOLA, a three year follow up study.

180 children with ASD, younger than 3 years old, were included in the IDEA RCT. Children were allocated to the ESDM treatment group or the treatment as usual group. The aim of IDEA-2 is to follow-up this population for 3 years after the initial 2 years of intervention, that is, 5 years after initial inclusion to IDEA.

Investigators hypothesize that children who received ESDM 12 hours per week will have a significant decrease of autism symptoms and will have a better scholastic level 5 years after initial inclusion to IDEA.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion in the initial IDEA trail
* Requiring less than 40 minutes travel to the assessment center

Exclusion Criteria:

* Impossibility of coming in for assessment
* Exclusion from IDEA
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001

The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
* Adult (age \>18 years old).
* Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis.
* Written informed consent obtained
Regulation of Placental Vascular Reactivity in Pregnancy-induced Hypertension

To elucidate the role of an imbalance in vasodilator prostacyclin (PGI2) and vasoconstrictor thromboxane (TxA2) in pregnancy-induced hypertension

BACKGROUND:

Pregnancy-induced hypertension (PIH) is associated with increased fetal and neonatal morbidity and mortality possibly resulting from hypoxia in utero. The primary pathology of PIH involves a reduction in uteroplacental blood flow but modern imaging techniques have now shown that increased impedance of the fetal-placental circulation and hence reduced blood flow can also be found in PIH. This may represent a direct effect of hypoxia or be a fetal adaptation to increase placental oxygen extraction to relieve hypoxia. The fetal-placental circulation is regulated by humoral agents and vascular pressure. An imbalance of vasodilator prostacyclin (PGI2) and vasoconstrictor thromboxane (TxA2) production is reported to underlie the vasoconstriction seen in PIH.

The study resulted from the 1986 release of a Request for Applications for Research on Hypertension in Pregnancy by the National Heart, Lung, and Blood Institute and the National Institute of Child Health and Human Development.

DESIGN NARRATIVE:

The fetal-placental circulations of perfused human placental cotyledons from normotensive and pregnancy-induced hypertensive pregnancies were used to determine if an imbalance in PGI2/TxA2 production existed and its relationship to the responses of the fetal-placental circulation to vasoconstriction. Studies were also conducted on the effects of hypocalcemia and hypomagnesemia, hypoxia, and drugs.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Transcranial Low Voltage Pulsed Electromagnetic Fields (T-PEMF) in Patients With Parkinson's Disease

The aim of this study, is to determine whether treatment using transcranial low voltage pulsed electromagnetic fields (T-PEMF) can reduce the symptoms patients with Parkinson's Disease (PD) experience. The symptoms include movement, mentality and the nervous system in general.

Furthermore the purpose of this study is to clarify whether a group of patients with PD, gain a statistical improvement in their symptoms when treated with active T-PEMF, compared to a group of patients with PD who receive placebo T-PEMF .


Eligibility Criteria:
Inclusion Criteria:

* Patients with Idiopathic Parkinson's disease H \& Y 1-3 (Hoehn\&Yahr)
* MMSE \> 22 (a screening test for dementia). (MMSE - Mini-Mental State Examination)
* Age \> 18 years.
* The patient is capable understanding, accepting and complete the planned procedures.

Exclusion Criteria:

* The patient has been using T-PEMF before.
* Changes in anti-parkinson drug treatment within the last 6 weeks
* Noticeable dementia or other brain injury, which may affect the ability to give consent, or complicates the assessment of the patient
* Psychosis, or other psychopathological conditions, which requires intervention
* The abuse of alcohol or drugs
* Treatment with Deep Brain stimulation.
* Pregnancy or nursing
* Epilepsy.
* Active implants such as pacemakers and others for example cochlear implants
* Active medical device for example insulin pumps, baclofen pumps.
* Participation in other trials in the intervention period
* Current or previous history of brain tumors, leukemia, malignant melanoma, skin cancer, or head and neck cancer
* Autoimmune disease
* Wounds in the scalp
The Medacta GMK SpheriKA Post-Marketing Surveillance Study

This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.

The aim of the current study is to collect clinical and radiological data to monitor the performances of the "GMK® SpheriKA" Knee Prosthesis implanted via the kinematic alignment technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to sign the informed consent.
* Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations.
* Patients 18 - 80 years of age at the time of surgery.
* Patients requiring a primary total knee replacement (on label use).
* Patients with intact collateral ligaments.

Exclusion Criteria:

* Patients with inflammatory arthritis.
* Morbidly obese patients, with a body mass index (BMI) \> 40.
* Patients with a history of total or unicompartmental reconstruction of the affected joint.
* Patients that have had a high tibial osteotomy or femoral osteotomy.
* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
* Patients that are immunologically compromised or receiving chronic steroids (\> 30 days).
* Patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and/or fixation to the prosthesis.
* Patients with an active or suspected latent infection in or surrounding the knee joint.
* Pregnant or breastfeeding women.
Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens

The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.

The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer;
* Has had a self-reported oculo-visual examination in the last two years;
* Has read, understood, and signed the information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
* Must be able to achieve 20/30 or better (in each eye) with the study lenses;
* Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
* Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
* Has no more than 0.75 diopters of refractive astigmatism;
* Has clear corneas and no active\* ocular disease;
* Has not worn lenses for at least 12 hours before the examination.

Exclusion Criteria:

* Is presently participating in any other clinical or research study including eye related clinical or research study;
* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Has any active\* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
* Has any known sensitivity to fluorescein dye or products to be used in the study.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
Non-invasive Optical Angiography in Age-related Macular Degeneration

Age-related macular degeneration (AMD) is the leading cause of severe and irreversible visual loss and classified blindness in the elderly throughout Europe and the US. Among these patients, about 6%-8% are afflicted with the advanced stages of AMD, which are responsible for the most severe visual loss. There is now convincing evidence that vascular endothelial growth factor (VEGF) is a major trigger for the formation of pathological choroidal vessels, responsible for the development of the neovascular form of AMD. Today, the gold standard for vascular imaging of the retina and diagnosis of CNV is angiography using fluorescein (FLA) or indocyanine green (ICG), which involves injection of the dye into a vein of the arm. In the recent years tremendous enhancements in the field of optical coherence tomography have been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that visualisation of CNV lesion size with non-invasive OCT angiography is not inferior to FLA/ICG angiography in treatment naïve and previously treated AMD patients.


Eligibility Criteria:
Inclusion Criteria:

- Patients with active CNV due to AMD as assessed by FLA/ICG angiography within 1 week prior to study inclusion

Exclusion criteria

Any of the following will exclude a patient from the study:

* Previous application of intravitreal drugs except anti-VEGF injections
* Active intraocular inflammation
* Presence of an intraocular disease except AMD and cataract
Immunotherapy Combined With Capecitabine Versus Capecitabine Monotherapy in Advanced Breast Cancer

The prognosis of advanced breast cancer does not improve much recently although varies of adjuvant drugs have been tried.Dendritic cells co-cultured with cytokine-induced killer cells(DC-CIK) immunotherapy has been proved to improve survival in several cancers, but its role in advanced breast cancer stains unclear. The purpose of this study is to evaluate the efficacy and safety of DC-CIK immunotherapy combined with capecitabine versus capecitabine monotherapy for the treatment of advanced breast cancer.

1.400 patients with advanced breast cancer should be definitively diagnosis based on histopathology, according to the 7th American Joint Committee on Cancer(AJCC) Cancer Staging Manual.

2.All patients will be randomly divided into group A（DC-CIK immunotherapy combined with capecitabine ) or group B（capecitabine monotherapy).

3.Patients in group A will receive 4 cycles of DC-CIK treatment (every 1 year) and capecitabine(continuous).Patients in group B will receive only capecitabine monotherapy(continuous) .

4.The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed with advanced breast cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 2.
* Hemoglobin≥10.0g/dL, Neutrophil count≥1.5×10\^9/L, Platelet count≥75×10\^9/L; total bilirubin(TBIL)≤1.5×ULN; alkaline phosphatase(AKP), aspartate aminotransferase(AST),ALT≤2.5×ULN(without metastasis of the liver), AKP,AST,ALT≤5×ULN(with metastasis of the liver); BUN≤1.5×ULN, Cr≤1.5×ULN.
* Patient received 1-2 kinds of cytotoxic chemotherapy previously.
* Patient never received capecitabine or other oral fluorouracil.

Exclusion Criteria:

* Patients who are suffering from serious organ dysfunction.
* HIV positive or other immunodeficiency disease.
* Patients who had used long time or are using immunosuppressant drugs.
* Patients who had active infection.
* Patients who were allergic to fluorouracil.
* Pregnant or lactating women.
* History of other malignancies.
* Other situations that the researchers considered unsuitable for this study.