cyrilzakka/clinical-trials huggingface dataset:
Vertical Femoral Neck Fractures in Young Adult Patients

Does the current techniques of internal fixation of vertical neck fracture in young adult patients give a satisfactory radiological and functional outcome at one year follow up?

* Displaced femoral neck fractures in young adults are most likely to result from high energy trauma that causes a vertically-oriented shearing injury through the femoral neck.
* The most descriptive classification used for femoral neck fractures in young patients is the Pauwels classification. As the degree of the femoral neck fracture line relative to the horizontal plane increases, the types differ (30 degrees type I, between 30 degrees and 50 degrees type II, 50 degrees type III), and the instability of the fracture.
* Greater fracture verticality contributes to greater difficulty in obtaining adequate stability to resist vertical shear forces around the hip, thereby resulting in ascending greater risk of complications such as nonunion and osteonecrosis despite a number of potential fixation strategies.
* The primary goals of surgery include preservation of the femoral head, avoidance of osteonecrosis, and achievement of a stable union.
* Fixation options include cannulated screws, sliding hip screw with or without an additional derotation screw,. among orthopedic trauma surgeons there is no consensus that a single fixation Option is superior for treating these injuries.

Eligibility Criteria:
Inclusion Criteria:

* Age of the patients from 20 to 50 years

  * Pauwel type III fractures
  * Recent fracture within one week

Exclusion Criteria:

* • Open fractures

  * Pathological or osteoporotic fractures.
  * Patient with comorbidities: D.M, renal patient, neurological deficits.
  * Patient associated with femoral head fractures or head impaction.
Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant

The aim is to assess the effect of injectable anticoagulants (unfractionated heparin (UFH), low molecular weight heparins (LMWH), fondaparinux, danaparoid, argatroban) on lupus anticoagulant testing assays over broad anti-Xa activity ranges and to establish their potential for causing false-positive or false-negative results.

Citrated whole blood was collected from subjects with positive lupus anticoagulant (LA) testing and from subjects with negative LA testing. Injectable anticoagulants were prepared in demineralized water and added to plasma samples LA+ and LA- to obtain broad anti-Xa activity ranges. Anti-Xa measurement and LA testing were performed in neat and spiked plasma samples. LA testing was performed with 4 different analyzer-reagent combinations to represent almost all hemostasis manufacturers currently available. There will be no direct comparison between the LA+ and LA- groups, the objective is to evaluate the effect of increasing concentrations of injectable anticoagulants on these 2 distinct populations.

Eligibility Criteria:
Inclusion Criteria:

* For all subjects:
* Adult male or female subject.
* In capacity to give informed consent to participate in the research.
* Affiliated to a Social Security system.

For the LA- group:

* Without a previous thrombosis and considered healthy on the basis of the interview and clinical examination.
* Without coagulation disease

For the LA+ group:

- Notion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive.

Exclusion Criteria:

For all subjects:

* Medical history considered by the investigator to be incompatible with the trial
* Refused participation
* Recent administration of oral or injectable anticoagulants
* INR \> 1.5
* Pregnant women, nursing mothers
* Guardianship, curatorship, deprived of liberty, safeguard of justice
Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block for Quadriceps Strength and Fall-risk

Our objective was to determine if an ultrasound guided ACB can preserve quadriceps strength, thus minimizing weakness of knee extension compared with ultrasound guided femoral nerve block. Our primary outcome was the percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 30 mins after either an ACB or FNB. Secondary outcomes included MVIC of knee extension at 60 min, hip adduction at 30 and 60 mins, and assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18yrs)
* ASA 1-2

Exclusion Criteria:

* BMI \>30
* Allergy to local anesthetics
* Pre-existing gait disturbance
* Pre-existing neuropathy
Study Evaluating MST-997 in Advanced Malignant Solid Tumors

The primary objective of this clinical research study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of intravenous (IV) MST-997 formulated in Intralipid 20% administered on a weekly schedule to subjects with advanced malignant solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Documented histological or cytological diagnosis confirming the presence of malignant solid tumor
* Tumor progression after conventional therapy for cancer or a malignant solid tumor for which no conventional therapy exists
* Subjects enrolled in the MTD confirmation cohort should have a documented histologic and/or cytologic diagnosis of metastatic breast cancer or non-small cell lung cancer (NSCLC) and should not have received more than 2 prior chemotherapy regimens for metastatic disease (adjuvant and neoadjuvant chemotherapy will not be included in the maximum of 2 prior regimens described above)

Exclusion Criteria:

* Subjects with symptomatic or clinically active central nervous system (CNS) metastases. Subjects who have had prior treatment with radiotherapy or surgical resection for CNS metastases will be permitted if CNS metastases have remained stable and have not required any treatment for at least 3 months prior to first dose of test article
* History of any other primary malignancy with less than 5 years documentation of a disease-free state (Subjects with a history of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ, which have been successfully treated, are not excluded)
* Recent major surgery (within 14 days before the first dose) or chemotherapy within 28 days before the first dose of MST-997 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
The Role of Erythropoietin in Myelodysplastic Syndrome

The purpose of the study is to elucidate the causative molecular events responsible for the abnormal erythropoiesis in MDS.

Myelodysplastic syndromes are a heterogeneous group of disorders characterized by clonal expansion of hematopoietic stem cells and ineffective hematopoiesis. Although all 3 cell lineages in myeloid hematopoiesis can be involved, the erythroid dysplasia and ineffective erythropoiesis of MDS are usually the most severe, and often precede the development of other bone marrow lineage defects.

In normal erythropoiesis, erythroid progenitors differentiate and proliferate in response to stimulation by erythropoietin (Epo). Epo binds to its receptor, EpoR, constitutively expressed at the surface of committed erythroid progenitors and induces homodimerization. This study is designed to evaluate the EpoR cDNA sequence and its level of expression in the clonal erythroid progenitors of MDS patients (in cells stratified for the same degree of erythroid maturation) to determine whether mutations in the EpoR may be responsible for an aberrant Epo signal transduction in MDS. As well as analyze intrinsic erythroid Epo expression to determine whether it differs between normal controls and patients with MDS and perform a microarray analysis of genes associated with Epo signal transduction to determine if MDS patients have abnormal expression of signal transduction proteins.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects greater than 18 years of age
* Diagnosis of MDS based on the French-American-British classification system (including secondary causes of MDS)

Exclusion Criteria:

* Subjects not meeting the criteria listed above
A Setting Focus Overdose Prevention Intervention

A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID).

This is a pilot of an injection setting targeted peer-driven intervention to reduce HIV/HCV transmission and overdose risk behaviors. Participants will be randomized to conditions: 1) Peer education and stocking of semi-public injection settings (SPIS) with risk reduction materials, and the standard of care. Based on their SPIS use, 120 index PWID participants will be selected.

A conceptual model for the intervention: The conceptual model is based on social influence, social network, and social cognitive theory. The prior work delineated social influence mechanisms. It is expected that training and modeling of effective communication skills will increase the occurrence of conversations on HIV/HCV and overdose prevention. These conversations will then alter perceived descriptive and prescriptive social norms of risk behaviors. The prior work is being enhanced by increasing the availability of risk reduction materials as well as the cuing and modeling risk reduction behaviors in risk settings. It has been found that PWID are motivated to conduct peer education; it enhances their status and provides them a prosocial role in the community. It is hypothesized that peer outreach and supply of materials to SPIS will lead to reduced sharing of injection equipment and increased naloxone availability.

Eligibility Criteria:
Inclusion Criteria:

* Current drug user (opioid use in the prior two weeks)

Exclusion Criteria:

* Any mental or physical health impairment that impedes ability to participate
Predictors of Prognosis in IBD Patients

A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease

Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory disease composed of two types: Crohn's disease (CD) and ulcerative colitis (UC). It is difficult to cure the IBD completely and patients with clinical or endoscopic remission can worsen again. Therefore, predicting the prognosis of patients with IBD is still challenging.

Endoscopic biopsied samples and blood samples from IBD patients and non-IBD controls have been collected and the expression levels of multiple markers which are associated with disease activity and severity will be assessed. The correlation between expression levels of multiple markers and prognosis will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* control group: Patients who do not have colitis, cancer, and advanced polyp (the number of polyps ≥ 3, the size of polyps ≥ 1cm, high-grade adenoma, villous adenoma)
* TNF-α inhibitor-naive IBD group: IBD patients who do not have a history of TNF-α inhibitor treatment
* TNF-α inhibitor-treated IBD group: IBD patients who are treated with TNF-α inhibitor

Exclusion Criteria:

* Age under 18 years
* Patients who were treated with antibiotics or probiotics within the last 3 months
Stromal Vascular Fraction Enriched PRP in Treatment of Post-acne Scars

in a split face fashion, 30 patients will be randomized into 3 groups: Group A: rt side treated with SVF enriched PRP, lt side treated with prp Group B: rt side treated with SVF enriched PRP, lt side treated with SVF Group C: rt side treated with PRP, lt side treated with SVF


Eligibility Criteria:
Inclusion Criteria:

* patients with atrophic post acne scars without any previous treatment trials.
* adequate blood picture, no anemia, no bleeding or platelet disorders.

Exclusion Criteria:

* pregnant and lactating females.
* elderly.
* patients with bleeding tendencies.
Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton

Obesity is a chronic illness of staggering proportions. Because weight loss through diet and exercise is difficult to attain and maintain, there has been escalating interest in bariatric surgery, including Roux-en-Y gastric bypass. Gastric bypass surgery results in long-term weight loss, dramatic improvement in comorbidities such as diabetes, and decreased mortality. Emerging evidence suggests, however, that gastric bypass may have negative effects on bone health. Because of the serious consequences of osteoporosis and fracture, this is of great concern. This study of the effects of gastric bypass on calcium metabolism and the skeleton may positively impact the clinical care of gastric bypass patients by their surgeons, primary care providers, and endocrinologists. Further, the knowledge gained may inform future investigation into the relationships between obesity, weight loss, and bone biology.


Eligibility Criteria:
Inclusion Criteria:

Scheduled to undergo gastric bypass surgery. Please note that to be eligible, one must already be working with a bariatric surgeon and with plans in place to undergo gastric bypass. This study is unable to arrange or pay for gastric bypass surgery.

Exclusion Criteria:

* Perimenopausal women
* Known intestinal malabsorption
* Prior bariatric surgery
* Use of medications known to impact bone and mineral metabolism
* Disease known to affect bone
* Illicit drug use or alcohol use \>3 drinks/day
* Serum calcium \>10.2 mg/dL
* Calculated creatinine clearance \<30 mL/min
* Weight \>350 pounds
* Wrist circumference \>12 inches or calf circumference \>17 inches
Effect of Food and Formulation on the Pharmacokinetics, Safety, and Tolerability of GNS561 After One Single Dose (50 and 200mg) in Healthy Volunteers

GNS561 is a drug used in preliminary phase 1b study for treatment of patients with primary and secondary liver cancer. The formulation used was oral capsule.The objective of this study in healthy volunteers is to compare pharmacokinetics, safety and tolerability of different formulations (tablets and capsules) and dosage (50 and 200mg) of GNS561 after single oral administration in first part and to evaluate the food effect on pharmacokinetics in second part.


Eligibility Criteria:
Inclusion Criteria:

* BMI will be between 18 (inclusive) and 26 kg/m² (inclusive).
* Participants must be in good general health, with no significant medical history, have no clinically significant (CS) abnormalities on physical examination, vital signs, and 12-lead ECG at Screening and/or before administration of the first dose of study drug
* Have a Fridericia's correction factor for QT (QTcF) ≤ 450 ms for male participants and ≤ 470 ms for female participants on 12-lead ECG
* Women subjects of childbearing potential must have a negative serum/urine pregnancy test at screening and baseline
* Women subjects of childbearing potential and male subjects must agree to use adequate highly effective contraception for the duration of study participation and up to 6 months following completion of therapy
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Able to understand and provide written informed consent.

Exclusion Criteria:

* Pregnant or breast-feeding mothers
* Known allergic reaction to quinolone derivatives (e.g., quinine, choloroquine, mefloquine)
* Subjects with any clinically significant laboratory abnormality
* History of QT prolongation (QTc ≥ 500 ms) or family history of long QT arrythmia or cardiac disease or bradycardia \< 50/mn or uncorrected hypokalemia
* On going uncontrolled infection disease
* History of pre-existing retinopathy or maculopathy
* Participation in any investigational clinical investigation ≤ 4 weeks prior to first planned dose of GNS561
* Malabsorption issues (e.g., gastric bypass or gastrectomy patients), current or history significant gastrointestinal diseases
* Patient with a mental or legal disability
Impact of Phonatory and Facial Morphology Disorders, on the Quality of Life of Adolescents With Pierre Robin Sequence

The study team has made the hypothesis that the intensity of the phonatory disorders (rhinolalia), and of the maxillo-mandibular growth anomalies (facial morphology), may have negative effects on the quality of life of adolescents with Pierre Robin sequence.

The investigators also want to assess the impact of 2 different surgical protocols of closure of the cleft palate (1 or 2 step(s)), on the current phonatory and morphology aspects. These 2 protocols were performed, by 2 parisian clinical teams, that have now been merged at Necker hospital.

In this protocol, the investigator will include patients who were treated, via maxillo-facial surgery, in their early childhood for a Pierre Robin sequence.

In the frame of a follow-up visit, if they accept to participate in the study, they will fulfill with 2 psychologists, 3 quality of life questionnaires, and 1 depression assessment questionnaire.

This will aim at evaluate their quality of life and their social integration, at the time of adolescence.

Eligibility Criteria:
Inclusion Criteria:

* Having a Pierre Robin sequence, either isolated, either integrated to a collagenopathy, or associated to any other malformation, but without any mental retardation
* Being schooled in normal environment, with a maximum of 2 years of academic delay
* Having being treated, in the early childhood, for a maxillo-facial surgery, either in Paris-Necker or Paris-Trousseau hospitals (1 or 2 step(s) protocols)

Exclusion Criteria:

* Having any other form of Pierre Robin sequence (syndromic or associated to a mental retardation)
* Having more than 2 years of academic delay, or being schooled in a specialized environment
* Having an organic severe intercurrent disease, that could have an impact on the quality of life of the patients.
Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.

To evaluate a Novel infusion protocol in MS patients treated with Alemtuzumab

This observational study will evaluate and anaylse primary data investigating the effects of a novel peri-infusion regimen in MS patients in a Candian clinical setting infused with Alemtuzumab.

This observational study has been developed by a Canadian neurologist with the intent to treat MS patients receiving Alemtuzumab in order to mitigate infusion associated reactions (safety) by utilizing an alternative peri-infusion protocol which is a deviation from the recommendation in the Canadian Product Monograph.

All the patients' recruited for this observational study were informed and consented for this novel peri-infusion regimen and were clinically followed by the neurologist for the two Alemtuzumab infusion cycles and for any subsequent Alemtuzumab infusions for potential mitigation of infusion associated reactions associated with Alemtuzumab.

Eligibility Criteria:
Inclusion Criteria: Patient s treated with Alemtuzumab as per canadian label -

Exclusion Criteria: Contraindication to Alemtuzumab

-
Effect of Physical Activity Intervention Children With Spastic Diplegia After Resistance Training

The purpose of this study is to investigate the effects of a 6-month physical activity intervention program on mobility and participation after the termination of a 6-week functional strengthening program for school-age children with spastic diplegia cerebral palsy. The primary outcomes are gross motor function, participation, and physical activity behavior.


Eligibility Criteria:
Inclusion Criteria:

* children with spastic diplegia, aged 6 to 12 year-old, and Gross Motor Function Classification System (GMFCS) level between I to III
* able to stand up from a chair independently and maintain standing for more than 2 seconds without falling
* able to answer questionnaire designed for school-age children
* able to follow verbal instructions

Exclusion Criteria:

* have orthopedic surgery, selective dorsal rhizotomy, or use of a baclofen pump within 6 months
* have orthopedic problems or other medical conditions preventing the child from joining the resistance exercise program, such as obvious LE joint contractures, uncontrolled epilepsy, or cardiopulmonary problems
* hearing loss or using hearing aid
The Effect of Constructivist Learning Model Based Gynecological Cancer Education

This is a randomised controlled study.The study was conducted to determine the effect of the constructivist education model given to women on gynecological cancer awareness, health Anxiety and spiritual well-being in women . The study population was composed of women living in Kastamonu. Women will be assigned to control and experimental groups. Women in the control group will receive gynecological education from Cancer Early Diagnosis, Screening and Education Centers (KETEM). The other group will receive gynecological cancer education based on the constructivist model.The hypotheses of the study are as follows:

H0: The of constructivist learning model -based health education programme does not have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety.

H1: The of constructivist learning model -based health education programme have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety.


Eligibility Criteria:
Inclusion Criteria:

* being 18 years old,
* being willing to participate in this study

Exclusion Criteria:

* having any neuropsychiatric disorder,
* having any physical or mental illness,
* being diagnosed with gynecological cancer,
* not attending theoretical trainings.
Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex

Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.


Eligibility Criteria:
Inclusion Criteria:

* in good general health based on investigator judgment
* able and willing to follow instructions, provide informed consent, make the required study visits, and use an electronic patient diary during the study
* possessing a best corrected visual acuity of at least 20/40 in each eye
* for females, using reliable contraception and a negative urine pregnancy test prior to study entry

Exclusion Criteria:

* contact lenses worn within 30 days prior to enrollment or during study period
* known hypersensitivity to study medication or any component
* presence of significant ocular or systemic disease that might interfere with the interpretation of the results
* a need for administration of chronic topical ocular or systemic medications of any kind during the study.
* participation in an opthalmic drug or device research study within 30 days prior to entry
Behavioral Skills Training Methods to Reduce Car Seat Misuse

The purpose of this study is to assess the effectiveness of child passenger educational methods to measure their ability to effectively reduce car seat misuse. The study will assess the traditional child passenger educational method delivered by a child passenger safety technician by comparing it to an in-person and virtual telehealth Behavioral Skills Training approach to reduce car seat misuse.

This study of 2,449 expectant couples involved two experiments. Experiment-1: included 1,224 participants, comparing 600 participants receiving no intervention and 600 participants receiving education with behavioral skills training (BST) in-person.

Experiment-2: included 1,224 participants, comparing 600 participants receiving BST-in-person to BST with telehealth.

Eligibility Criteria:
Inclusion Criteria:

* Women at least 7-month gestation and their partner, living within Los Angeles, Ventura, Orange, San Bernardino or Riverside counties; consented to the study and follow-up evaluation; and at the time of session had their child restraint system(s) and vehicle(s) available.

Exclusion Criteria:

* None