cyrilzakka/clinical-trials huggingface dataset:
Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?

The goal of this study is to determine whether inducing labor with just one dose of misoprostol, followed by treatment with oxytocin, will still be effective enough to increase the chances of having a successful vaginal delivery as compared to using more than one dose of misoprostol, followed by treatment with oxytocin.

This study involves a comparison of two different regimens of prostaglandin use for "cervical ripening" prior to induction of labor. Women admitted to the hospital for induction of labor who are found to have "unripe" cervixes at the time of admission, and who agree to participate in the study will be randomly assigned to one of two treatment groups. In one group, a single dose of 25 µcg of misoprostol will be administered vaginally and four hours later oxytocin induction will be started if clinically indicated. In the second group of women, repeat doses of misoprostol will be given every four hours up to six doses unless labor or cervical ripening occurs sooner. At this point, oxytocin will be started as needed. Success of vaginal delivery by 24 hours, time from initiation of protocol to delivery and cesarean section rates will be compared. Complications such as postpartum hemorrhage, episodes of tachysystole with fetal compromise and chorioamnionitis and endometritis will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Any pregnant woman undergoing induction of labor
* Live singleton pregnancy ≥ 37 week gestation
* Bishop score \< 6
* Category I fetal heart rate

Exclusion Criteria:

* Contraindications to vaginal delivery (e.g. vasa previa, placenta prevue,non-vertex presentation, umbilical cord prolapse, and active genital herpes infection.)
* Pregnancies complicated by major fetal anomalies
* Any contraindication to the use of misoprostol, including
* History of previous c-section or major uterine surgery
* Prior allergic reaction
* Category II or III fetal heart rate
* Regular uterine contractions ≥ 3 in a 10-minute period persistent for at least 30 minutes
* Estimated fetal weight \< 10 percentile
* Premature rupture of membranes
* Age \< 18 years old
* Women who do not have the capacity to consent
Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders

Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial model, but pathophysiology remains relatively unknown, and robust etiological models to guide treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability factors have been found in eating disorders including decision making abnormalities. The investigators hypothesize that decision making abnormalities are associated with a lower level of functioning and quality of life which could lead to social and interpersonal difficulties. The investigators also hypothesize that these anomalies are associated with a particular clinical profile (more restrictive profile, more hyperactivity, less insight on the disease and desire for care ...).

The investigators will recruit a total of 340 patients with an eating disorder in the university hospital of Montpellier.

* Participation consists of a one-day visit with a multidisciplinary assessment. No action is specific to research. This is the usual management of patients with eating disorders addressed to our department.
* An ancillary study will be proposed, if the patient is addressed by his general practitioner for an annual evaluation. This second visit will be exactly the same as the initial visit.

Eligibility Criteria:
Inclusion Criteria:

* Patient with an eating disorder according to Diagnostic and Statistical Manuel of Mental disorders-V (DSM-V) criteria
* Patient aged from 15 to 65 years
* Patient who performs the day-hospital evaluation
* Patient affiliated to a French social security system
* Patient able to understand the nature, the aim and the methodology of the study
* For minor one of the legal guardians gave his consent

Exclusion Criteria:

* Patient in an unstable somatic state (eg severe metabolic disorder making impossible or unreliable neuropsychological assessments)
* Patient's refusal to participate
* Patient on protective measures (guardianship or trusteeship)
* Pregnant or nursing women. A dosage of beta human chorionic gonadotropin (βHCG) will be performed to ensure the absence of pregnancy.
OCTA Study of Choroidal Vasculature in Open Angle Glaucoma Patients

The aim of the present study was to examine and measure SFCT and CCVD using respectively EDI-OCT and OCTA in preperimetric and advanced glaucomatous eyes, in order to shed light on the vascular pathogenesis of glaucoma disease.


Eligibility Criteria:
Inclusion Criteria:• age older than 40 years

* diagnosis of glaucoma
* absence of diabetes, heart diseases, hypertension
* absence of drug intake
* absence of vitreoretinal, vascular retinal diseases
* absence of previous ocular surgery and congenital eye diseases.
* absence of errors of refraction
* absence of lens opacities
* absence of low-quality OCT and OCTA images

Exclusion Criteria:

* age younger than 40 years
* presence of diabetes, heart diseases, hypertension
* vitreoretinal and vascular retinal diseases
* previous ocular surgery and congenital eye diseases
* errors of refraction
* lens opacities
* low-quality OCT and OCTA images
Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity

The aim of the present study is to compare the effect of iso-energetic energy deficits induced by energy restriction alone or exercise + dietary restriction (Mixed deficit) on energy intake and appetite feelings in adolescents with obesity.

The present study will compare the nutritional response to an energy deficit of 500 kcal induced once by dietary restriction alone and once by a mixed deficit (50% by exercise and 50% by dietary restriction) (compared with a control condition). 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (CON); ii) one session with a dietary-induced energy deficit (Def-EI); iii) one session with a mixed deficit (50% by exercise and 50% by dietary restriction) (Def-Mixed).

Their ad libitum energy intake will be assessed at dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

* Previous surgical interventions that is considered as non-compatible with the study.
* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks
Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?

The purpose of this study is to determine whether drainage after prosthetic repair of incisional abdominal hernias increases or decreases complications such as infection, seromas and hematomas.

Between 3 to 20% of patients who received a midline laparotomy will develop an incisional hernia.

Primary suture of the defect is associated with a recurrence rate between 25 and 50%.Mesh repair is superior with regard to the recurrence (12-20%), but early postoperative complications include infections, hematomas and seromas.

Some advocate the use of drains in order to diminish secretions and complications. Other claim that drains increase the complication's rate.

In the absence of a randomized controlled trial it's not clear whether drainage could influence positively or negatively the occurence of such complications when performing a prosthetic repair of abdominal incisional hernia.

The aim of this study is to answer this question, comparing prospectively two groups of operated patients: the former with drainage and the latter without.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of midline abdominal wall incisional hernia
* Adults of 20 to 80 years old
* ASA I to III
* Inform consent signed by the patient and investigators

Exclusion Criteria:

* Incisional hernia less than 2 cm
* Groin hernia
* Antibiotic treatment before and during hospital admission
* Emergency admission for strangulated incisional hernia
* Immunosuppressing treatment
Long Term Follow Up Of Patients Who Have Received Gene Therapy Or Gene Marked Products

This protocol (GENEFU) provides a mechanism for the 15-year followup period that the FDA requires for all participants in gene transfer protocols and assures that adequate followup can be maintained for a wide variety of participants on different individual gene therapy protocols at St. Jude Children's Research Hospital.

GENEFU serves as an umbrella protocol for long-term follow-up (LTFU) for recipients of gene therapy/gene marked (GT/GM) products at St. Jude Children's Research Hospital. The FDA has recommended methods to assess the risk of delayed adverse events after GT/GM and has provided specific requirements regarding the duration and design of LTFU observations. This protocol is intended to provide LTFU in accordance with the FDA guidelines for those who received a GT/GM product as part of a St. Jude-sponsored clinical trial or compassionate use treatment plan. The protocol calls for a physical examination or general health evaluation and collection of required blood samples annually for up to 15 years after the last receipt of a GT/GM product.

Goals will be to obtain clinical histories in order to detect late clinical outcomes suggestive of retroviral or lentiviral disease, including but not limited to cancer/second malignancies, neurologic disorders, autoimmune disorders, and hematologic disorders. Blood samples will be archived and tested when clinically or scientifically indicated, as in the event of development of a second malignancy. This prospective cohort study will utilize descriptive statistics in the analysis of long-term late effects outcomes. It offers a uniform approach to long-term safety monitoring in research participants who have received a gene-transduced product as part of St. Jude-sponsored GT or GM protocols and compassionate use treatment plans.

Secondary objectives include the following: to obtain and archive blood samples to 1) detect frequency of vector marking in peripheral blood mononuclear cells when clinically or scientifically indicated, such as in the event of participant development of second malignancy, autoimmune disease, hematologic abnormality, or neurologic event, and; 2) To obtain and archive blood samples to detect and characterize clonal proliferation events occurring in gene transfer trials when clinically or scientifically indicated.

Eligibility Criteria:
Inclusion Criteria:

* Has received an integrating retroviral or lentiviral vector based GT/GM product at St. Jude Children's Research Hospital within the past 15 year time period. Patient is no later than 15 years post receipt of GT/GM product.
Immediate Implant Placement in the Esthetic Zone With and Without Using Autogenous Mixed With Xenograft

Xenografts are graft materials derived from the inorganic portion of animal bones; the most common source is bovine the removal of the organic component are processed to remove their antigenicity, while the remaining inorganic components provide a natural matrix as well as an excellent source of calcium. The disadvantage of xenografts is that they are only osteoconductive and the resorption rate of bovine cortical bone is slow.

However leaving the jumping gap empty has been the gold standard for immediate implantation as the formed blood clot will allow bone fill in that area.

Not using a grafting material in the jumping gap was chosen as a comparator as it's the standard procedure usually applied and showed high success rates. This should allow us to assess whether the chosen grafting material would have a positive influence on the study outcomes as compared to it.

Intraoral and extraoral autologous bone grafts could be considered as the "Gold standard" pre-prosthetic dentoalveolar reconstruction of atrophic jaws with cortico-cancellous bone grafts from intraoral and/or extraoral donor sites as a predictable technique for the facilitation of dental rehabilitation of atrophic ridges, associated with high bone survival rate and long term implant success. Autogenous bone corresponds to bone graft obtained from the same individual. It is considered the gold standard for filling of bone defects since it allows (I) osseointegration: direct contact with bone tissue without fibrous tissue ; (II) osteoconduction: support to bone growth (III) osteoinduction: differentiation of mesenchymal cells of surrounding tissue (receptor site) into osteoblastic cells ; and (IV) osteogenesis: bone neoformation by osteoblastic cells present in the graft material. Although few mature osteoblasts survive to grafting, precursor cells are responsible for the osteogenic potential

Eligibility Criteria:
Inclusion Criteria:

* Age from 20-60 years
* Both sexes
* non-restorable maxillary incisors, canine and premolars
* Good oral hygiene
* Adequate bone height apical to the alveolus of the failing tooth

Exclusion Criteria:

* Systematic disease which affect osseointegration (uncontrolled diabetes, cancer, etc...)
* Bad oral hygiene
* Bruxism, clenching, deep bite, edge to edge and abnormal habits
* Non-treated periodontal diseases
* Pregnancy and smokers
* Severe infection
* Absence of labial plate of bone (Fenestration, dehiscence).
The Gluten-Casein-free Diet in Children With Autism: A Clinical Results of the Ophthalmic and Behavioral Manifestations

To evaluate the efficacy of eight weeks of GFCF in children with ASD on autistic symptoms and ophthalmic findings such as corneal reflex, interpupillary distance (IPD) and pupil size.

Autism spectrum disorder (ASD) is a common condition. ASD is a heritable illness characterized by early-onset differences in interaction, communication, sensory atypicality, and stereotyped behaviors. Recent studies suggest a link between elimination diets and severity of autistic behaviors. The etiology of ASD has been still uncertain. Therefore, elucidating the underlying pathology may assist in risk assessment and facilitate process management. Non-harmful and existing evidence for the diet's benefits in ASD must be elucidated.

Primary Study Objective:

To assess the effect of a GFCF diet on variables autism index, stereotyped behaviors, communication, social interaction associated with ASD.

The pupillary response can be utilized to anticipate neurological and physiological activities under the surface. Changes in light trigger the pupil response, which adjusts the amount of brightness falling on the retina by instinctively constricting or dilating the pupil. Atypical pupil size has been linked to abnormal autonomic function in people with ASD. Disturbances in autonomic functions may also lead to differences in the corneal reflex. This study aimed to obtain more data on the behavioral symptoms and ophthalmic measurements of gluten-free casein-free (GFCF) on ASD. In addition, normal development children and children with autism may differ in facial morphology. This study also evaluates the effect of GFCF diet on IPD distance.

Secondary Objectives:

To assess the role of GFCF diet in the manifestation of opthalmic measurements such as pupil size, corneal reflex and IPD.

30 children with ASD were enrolled in a 8-weeks prospective GFCF diet treatment study. In the study, a single group was evaluated with measurements before and after dietary intervention.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent / Assent, as applicable must be signed prior to executing any study related procedure
* Children, male or female, 2 to 11 years old (inclusive)
* Confirmed diagnosis of ASD according to the DSM-IV Symptom Checklist
* Ability to maintain a gluten- and casein-free diet during the study

Exclusion Criteria:

* Cardiovascular, psychiatric, autoimmune, cancer, etc. children with secondary different disease
* Children with any drug use
* Children currently receiving treatment with any alternative medical methods (eg.hyperbaric).
* Children with a diagnosis of celiac disease
* Children who have received any dietary treatment before
The Relation Between Periodontal Disease and Metabolic Syndrome

Periodontal disease is associated with the components of Metabolic syndrome, such as obesity, diabetes, hypertension and hyperlipidemia. Therefore, strong relation with periodontal disease and metabolic syndrome is suggested. the overall goal of this study is to define the relation between periodontal disease and metabolic syndrome, including atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with periodontal disease

Exclusion Criteria:

* Patients with malignant disease
* Pregnant women
Common Factors Group Psychotherapy for General Mental Health Concerns

The current research will investigate the impact of general psychotherapy using common factors (i.e., techniques and communication skills that are common to all major forms of psychotherapy) to investigate whether mental health professionals can treat a variety of mental health concerns utilizing this general form of psychotherapy as opposed to specific forms of psychotherapy that may require specific trainings or education.

The current research will investigate the impact of general psychotherapy using common factors (i.e., techniques and communication skills that are common to all major forms of psychotherapy) to investigate whether mental health professionals can treat a variety of mental health concerns utilizing this general form of psychotherapy as opposed to specific forms of psychotherapy that may require specific trainings or education.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Experiencing self-reported psychological distress

Exclusion Criteria:

* has engaged in self-harm within the last three months
* has attempted suicide within the last year
* has had an active plan to attempt suicide within the last 30 days
* currently diagnosed with any eating disorder
* has experienced hallucinations or delusions within the last 30 days
* has used narcotics within the last 7 days (heroin, meth, crack cocaine, opioids)
Directional Deep Brain Stimulation With Patients With Advanced Parkinson's Disease

The aim of the study is to assess the clinical outcome in patients with Parkinson's disease treated with directional deep brain stimulation (dDBS). The patients have been selected for the dDBS treatment by their treating neurologist. The study is a registry-based follow-up study.

The study group consists of patients with advanced Parkinson's disease treated with directional deep brain stimulation in Helsinki University Hospital between 2017 - 2020. The study is a registry-based follow-up study. The aim of the study is to assess the clinical outcome and possible adverse effects of the dDBS treatment. The data will be collected from the patient records. The observed time points are 6-month's, 12-month's and 18-month's postoperative visits.

The following data will collected: the scores of Unified Parkinson's disease questionnaire part III (UPDRS-III), Non-Motor Symptoms Questionnaire (NMS-quest), Beck Depression Inventory (BDI), Mini-Mental State Examination (MMSE), Abnormal Involuntary Movement Scale (AIMS) evaluated in the screening phase for dDBS treatment and at 6-months' follow-up. Possible levodopa equivalent dose changes, LEDDs, will also be assessed at these time points.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced Parkinson's disease and treated with directional deep brain stimulation

Exclusion Criteria:

* patients with advanced Parkinson's disease and not treated with directional deeb brain stimulation
Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus

The aim of this study was to assess tolerability and safety of three different formulations of an anti-HIV immunotherapy based on autologous dendritic cells (DCs) pulsed with HIV chemically inactivated with Aldrithiol™-2 (AT-2). Patients were chronically infected with HIV, naïve for antiretroviral drugs. A possible immunological and virological favorable impact was also assessed.


Eligibility Criteria:
Inclusion Criteria:

* patients with HIV infection;
* absence of antiretroviral therapy, antineoplastic therapy or the use of corticosteroids for at least six months prior to study entry;
* plasma viral load ≥ 1,000 copies / mL, stable (ie no variation \> 0.5 log) in the six months before the start of the study;
* blood CD4+ T cells ≥ 350 /mL, stable (ie no variation \> 25%) in the six months before the start of the study.

Exclusion Criteria:

* individuals without proper venous access for blood and apheresis collection procedure.
* use of drugs, alcohol, psychiatric disorder or any condition that interferes with the ability of patients to follow the requirements of the study;
* history of diagnosis of HIV infection \<01 years;
* pregnancy or breast-feeding;
* use of antiviral therapy, in anticancer therapies or corticosteroids six months prior to study start;
* presence of chronic diseases, such as infection with hepatitis B (HBV) and C (HCV), human T-lymphotropic virus (HTLV) I / II or any condition that promotes immune system dysfunction, with the exception of HIV infection.
Lateral Ankle Sprain Study

The purpose of this study is to compare the short term treatment outcome measures of the standard of care air cell stirrup brace to that of a high tide fracture boot in patients with lateral ankle sprains.

100 patients with Grade II-III lateral ankle sprains requiring crutches will be invited to participate. Patients will randomly be assigned to be treated with either the Air Cast Stirrup Brace (n=50) or the High Tide Fracture Boot (n=50). All patients will be given instructions to use the fracture boot or air cell brace at all times of ambulatory activity until follow-up and to use NSAIDS as needed. At their 2 week post-sprain follow-up the following outcomes measures will be assessed: Modified Karlsson score (disease specific survey) Pain VAS Patient satisfaction with treatment VAS SMFA (general health measure) Ability to walk without crutches

Eligibility Criteria:
Inclusion Criteria:

* Age 18 \& Over
* Lateral Ankle Sprain (Grade II or III) presenting within 48 hours of initial injury without prior treatment

Exclusion Criteria:

* Patients less than 18 years old
* Those not able to give consent
* Women who are pregnant or are expecting to become pregnant
* \> 48 hrs from injury at time of presentation
* Prior treatment for injury
* Fracture at time of current ankle injury or previous ankle fracture
* Deltoid ligament injuries
* Other orthopaedic injuries at time of presentation
* Intoxication
* Workman's Compensation injury
* Mental Illness
* Dementia