cyrilzakka/clinical-trials huggingface dataset:
The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry

The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery.

This is a central repository with data from 25-40 participating SOAP institutions/hospitals.

The primary and secondary aims of this study are as follows:

1. To determine the institutional factors associated with rates of general anesthesia for cesarean delivery
2. To perform a descriptive analysis of characteristics of general anesthesia for cesarean delivery cases
3. To determine maternal and anesthetic predictors of difficult intubation

Data will be collected from each participating SOAP institution. Institutional data will include information on the characteristics of the institution such as maternal level of care, numbers of lives birth, staffing models, etc. This data will be collected prior to subjects being enrolled into the registry and again at the registry closure to look at intuitional changes over time.

Inclusion into the registry is based on the following criteria:

1. Pregnant women who have had a general anesthetic for Cesarean delivery
2. 15-55 years old

The general anesthesia registry will collect data on subject demographics in a deidentified manner, including characteristics of the birth and delivery, gestational age, maternal morbidities, and anesthetic management.

The granular detail requested in the registry database will help to better understand the nuances of how and why decisions are made about proceeding with general anesthesia in these cases, and once done, how to implement this clinical course. As not all of these data points are routinely recorded in the medical record, optimal data capture requires the treating anesthesiologist to complete the registry entry as soon as possible after conclusion of patient care.

Data will be collected for approximately 5 years and maintained indefinitely. Data is entered into a Yale REDCap registry and will not contain subject identifiers. An estimated 5000 subjects will be enrolled into the data repository. This is based on a published report of 45 institutions' data investigating a subtopic of this question (15 years yielding 15,000 general anesthetics).

Eligibility Criteria:
Inclusion Criteria:

-Pregnant women aged 15-55 who have had a general anesthetic for Cesarean delivery
Vertical Versus Inclined Implant to Retain Locator Maxillary Overdenture

Objectives: evaluate the success rate, prosthetic maintenance , clinical and radiologic results of vertical implants with straight abutments versus inclined implants with angled abutments to retain locator maxillary overdentures. There were two groups : 1) The control group 2) The study group

the aim of the present investigation was to evaluate the success rate, prosthetic maintenance , clinical and radiologic results of vertical implants with straight abutments versus inclined implants with angled abutments to retain locator maxillary overdentures.

Materials and Methods conducted on 12 patients (6 males and 6 females) aged 58 to 68 years with completely edentulous maxillary ridges opposing implant-retained mandibular overdentures. Patients admit to the prosthodontic department, Faculty of Dentistry, Mansoura University for oral rehabilitation by implant-supported maxillary prostheses. Patients were allocated into one of two treatment groups: 1) The control group ; included 6 patients (3 males and 3 females) who will receive 4 vertical implants with straight trans mucosal abutments retaining locator maxillary overdenture 2) The study group; include 6 patients (3 males and 3 females) who will receive 4 inclined implants with angled trans mucosal abutments for retaining locator maxillary overdenture. Randomization and allocation of patients into treatment groups was made by dental personnel who is blind to treatment groups.

Eligibility Criteria:
Inclusion Criteria:

1. Unable to wear the upper denture
2. Radiographic diagnosis of bone loss

Exclusion Criteria:

1. Neuromuscular diseases
2. Insulin dependent diabetes
Study of the Correlation Between Post-traumatic Stress Disorder and Paradoxical Sleep Behavior Disorder

Post-Traumatic Stress Disorder is a psychiatric disorder that occurs after a traumatic event and is estimated to affect 5 to 12% of the general population. Around 70% of patients suffering from this disorder report sleep disorders (sleep apnea, insomnia, recurring nightmares, etc.).

There are specific sleep disorders called Rapid Eye Movement (REM) sleep behavior disorders which correspond to nocturnal restlessness with sometimes violent behavior, often associated with intense dreams during a phase of sleep called REM sleep. These disorders are more frequently found in patients suffering from post-traumatic stress, such as veterans.

However, the physiopathological link between these two disorders is poorly understood and studies on this subject are few in number. Through this study, the investigators wish to demonstrate whether there is a correlation between the severity of Post-Traumatic Stress Disorder and that of Rapid Eye Movement sleep behavior disorder.

The main objective is to study the relationship between the severity of Post Traumatic Stress Disorder (PTSD) and the Rapid Eye Movement (REM) Sleep Behavior Disorder.

This is an observational prospective study based on 4 questionnaires relating to the sleep (PSQI), the severity of the Rapid Eye Movement (REM) Sleep Behavior Disorder (REM RBDSQ, IRBD-SSS) and the severity of the Post-Traumatic Stress Disorder (PCL-5).

Type of study: observational prospective study

Study duration : 40 min, one visit at D0 (inclusion isit)

Number of center: 1 (Clermont Ferrand)

Patients: 60 patients suffering from type 1 Post-traumatic Stress Disorder .

Patients will be selected during their consultation, at the CUMP (Medico-Psychological Emergency Cell) of the hospital of Clermont-Ferrand. If patients accept to participate to this study, demographic and clinical data (age, sex, current treatments, medical and surgical history) will be collected. Then, they will complete 4 questionnaires :

* the Rapid Eye Movement Behavior Disorder Screening Questionnaire (REM RBDSQ)
* the Rapid Eye Movement Behavior Disorder symptom severity scale score (IRBDSSS)
* the quality of sleep inventory (PSQI)
* the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL 5)

Eligibility Criteria:
Inclusion Criteria:

* Adult patient aged 18 to 50 years.
* French speaking.
* Having a diagnosis of type I Posttraumatic Stress Disorder according to DSM 5.

Exclusion Criteria:

* Presence of acute mental illnesses in the process of decompensation.
* Presence of a Central Nervous System disorder (e.g. neurodegenerative diseases, Stroke, Multiple Sclerosis (MS), Narcolepsy, etc.)
* Patient under guardianship, curatorship, or legal protection.
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus

The purpose of this study is to assess the safety and tolerability of JNJ-56022473 following multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus Erythematosus (SLE) and to determine whether premedication with corticosteroids is required to improve the tolerability of SC JNJ-56022473.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have a body weight in the range of 40 to 100 kilogram (kg), inclusive, and have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2), inclusive, at screening
* Subjects eligible for enrollment in this study must qualify as follows: a) must meet Systemic Lupus International Collaborating Clinics (SLICC) criteria for diagnosis of lupus and b) must have at least one non-serologic clinical activity defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) within 3 months prior to first study agent administration
* Have a positive gene signature score during screening, prior to first administration of study agent
* Subjects using allowed pre-existing lupus treatments, if stable for at least 6 weeks prior to the first dose of study medication:

  1. oral corticosteroids equivalent to an average dose up to or equal to (\<=) 10 milligram (mg) of prednisone/day
  2. use of antimalarials (such as chloroquine or hydroxychloroguine) for at least 8 weeks
  3. maximum of 1 non-corticosteroid immunosuppressive drug

Exclusion Criteria:

* Subject with history or suspected occurrence of drug-induced systemic lupus erythematosus (SLE)
* Subject has unstable lupus nephritis and/ or has active Central nervous system (CNS) lupus or history of severe CNS lupus, including but not limited to seizures, psychosis, transverse myelitis, CNS vasculitis and optic neuritis
* Major surgery prior to, and, if planned, during and shortly after the study is not eligible
* Subject has or has had an acute illness, including a common cold, within 2 weeks prior to the study agent administration or has had a major illness or hospitalization within 4 months prior to the screening visit
* Any other inflammatory diseases that might confound the evaluations of efficacy are excluded
Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis

Gastroparesis (GP) is describing a condition when stomach does not empty as fast as it should. This fact creates the situation, when food stays in the stomach for a long time and it causes symptoms of nausea, vomiting, loss of appetite, bloating, inability to finish normal size meal and abdominal pain. There are not many drugs available to treat this condition and majority of gastroparetic patients are not responding well to them after they are on it for some time. Many investigators are able to implant Gastric Stimulator System (GES) under FDA approved status of Humanitarian Device Exemption (HDE) definition. In the last few years it became possible to add another surgical procedure, which is called pyloroplasty (making bigger opening on the end of stomach), may help even more as it is also increasing the rate of the emptying of the stomach. Therefore this study is proposing to evaluate if GES in combination with pyloroplasty is much better than pyloroplasty alone. For this reason, two of these procedures will be introduced surgically at the same time, but GES devices will not be turn ON in half of these participants for 3 months. After that time all subjects will have their devices turned ON. All subjects will be asked to evaluate their symptoms of gastroparesis and their quality of life during clinical visits, and investigators will conduct pathological analyses of tissue obtained during surgery.

GES system (Enterra Therapy) involves surgical implantation of a pulse generator in the abdominal wall and 2 electrodes into the muscularis propria of the stomach. Well established procedure, called pyloroplasty, will be performed during the implantation of GES system, therefore all participants will have both surgeries done at the same time. Half of them will be randomized to keep GES ON after surgery, and other half will have GES turned OFF for 3 months.

Both groups will be followed for additional 3 more months. Study related questionnaires and diagnostic/ clinical tests will be obtained at all points of interest of this study.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of GP for \> 1 year and refractoriness to anti-emetics and prokinetics; more than 7 emetic episodes per week;
* Delayed GE (gastric retention greater than 60% at 2 h and/or greater than 10% at 4 h) based on a 4-h standardized radionuclide solid meal test

Exclusion Criteria:

* Organic or pseudo-obstruction, primary eating or swallowing disorders, positive pregnancy test result, psychogenic vomiting, peritoneal dialysis, drug dependent, morbid obesity, active malignancy
Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in Girls

The purpose of this study is to determine the effects of galactooligosaccharide (GOS) supplementation on calcium absorption and and gut microbe profiles.

Galactooligosaccharides (GOS) have been shown to have positive effects on calcium absorption in animals and postmenopausal women. This study aims to see whether the addition of fiber in the form of GOS to a calcium-containing yogurt drink will increase calcium absorption compared to placebo in a group of girls near menarche. Secondary outcomes are to assess physical fitness and determine the relationship between physical fitness and calcium absorption in adolescent girls as well as assess changes in gut microbiota. During this three phase, randomized, controlled crossover study, participants will consume yogurt drinks supplemented with 0, 2.5 or 5 grams of GOS twice daily for three weeks. Following each three week period, participants will complete a weekend clinical visit to measure calcium absorption. Height, weight, bone density and geometry, calcium absorption, gut microbiota and physical fitness will be measured. Effects of this GOS fiber intervention may help elucidate a mechanism of action for improving bone health with fiber supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Female between ages of 10 and 12
* Calcium intake of 900-1300 mg/d

Exclusion Criteria:

* Take medication that influences calcium metabolism
* Any disorder of calcium or bone homeostasis
* BMI\>90th percentile for age
* Smoking, illegal drug consumption
* Any gastrointestinal disease (crohn's disease, celiac disease, inflammatory bowel disease)
* Any disease affecting kidney function
* Broken bone within last 6 months
* Dislike of yogurt or yogurt drinks
* Regular use of foods containing probiotics or prebiotics
A Trial Evaluating TG4050 in Ovarian Carcinoma.

This is a multicenter, open-label, single arm phase I study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent.
2. Female patients ≥ 18 years
3. Histologically confirmed high grade, advanced stage serous ovarian, fallopian tube or primary peritoneal carcinoma.
4. Patients who have undergone primary debulking surgery or interval debulking surgery and have completed standard first-line platinum-based chemotherapy and for whom tumor tissue has been banked.
5. Patients must have achieved a complete response to therapy
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment period initiation
7. Adequate hematological, hepatic and renal functions.

Exclusion Criteria:

1. Patient having received any cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins such as anti-Programmed cell death 1 (anti-PD1), anti-Programmed death-ligand 1 (anti-PDL1) or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTL4)
2. Patients with other active malignancy ≤ 3 years prior to registration except non-melanoma skin cancer, stage 0 in situ carcinoma.
3. Patient post-organ transplantation, including allogeneic stem cell or bone marrow transplantation.
4. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS (Acquired Immune Deficiency Syndrome).
5. Any known allergy or reaction to eggs or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products.
6. Acute or chronic infection with hepatitis C Virus (HCV) or Hepatitis B Virus (HBV).
7. Major surgery within 4 weeks of treatment start.
8. Treatment with another investigation agent within 30 days prior to TG4050 treatment initiation.
9. Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs . Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
10. Use of live vaccine for the prevention of infectious diseases during the four-week period prior to TG4050 treatment initiation planned date. Furthermore, patients should not receive any live vaccine during the period of study treatment administration.
11. Uncontrolled intercurrent illness.
Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)

To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have Stage IIIB (with malignant pleural effusions) or Stage IV histological or cytological confirmation of non-small cell carcinoma (excluding squamous)
* Age \>/= 18 years old
* Patients must have at least 1 evaluable lesion. Lesions must be evaluated by CT scan or MRI
* ECOG Performance Status of 0 to 1
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:

  * Hemoglobin \>/= 9.0 g/dL
  * White blood cell (WBC) count \>/= 2,500/mm3
  * Absolute neutrophil count (ANC) \>/= 1,500/mm3
  * Platelet count \>/= 100,000/mm3
  * Total bilirubin \</= 1.5 times the upper limit of normal (ULN)
  * ALT and AST \</= 2.5 X ULN (\</= 5 X ULN for patients with liver involvement)
  * INR \</= 1.5 and aPTT within normal limits
  * Serum creatinine \</= ULN or creatinine clearance (CrCl) \>/= 45 mL/min (CrCl = Wt (kg) x (140-age)/72 x Cr level, female x 0.85) for patients with creatinine levels above institutional normal
  * Urinalysis (UA) must show less than 1+ protein in urine, or the patient will require a repeat UA. If repeat UA shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein \</= 1000 mg/24 hour to be eligible

Exclusion Criteria:

* Patients with squamous histology
* Cardiac disease: Congestive heart failure \> Class II NYHA; active coronary artery disease (MI more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management
* HIV infection or chronic hepatitis B or C
* Active clinically serious infections (\> Grade 2 NCI-CTC Version 3.0)
* Evidence or history of CNS disease, including primary brain tumors, seizures disorders, or any brain metastasis
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture

Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.


Eligibility Criteria:
Sufficient correction of metacarpophalangeal (MCP) joint during the PNF treatment, defined as \<20° passive extension deficit (PED), is a prerequisite for inclusion.

Inclusion Criteria:

* Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer
* DC of either II-V finger
* Well-defined/palpable cord

Exclusion Criteria:

* Legally incapacitated
* Previous study inclusion with another finger ray
* Isolated proximal interphalangeal (PIP) or distal interphalangeal (DIP) joint contracture, defined as MCP joint contracture \< 20° PED regardless of the deficit in the PIP or DIP joint
* Previous hand surgery of the affected finger for any reason
* Known allergy to the study medication
* Anticoagulant therapy (Acetylsalicylic acid is NOT an exclusion criterion)
* Pregnant or lactation
* Insulin dependent diabetes mellitus
* Ongoing systemic infection or local infection at the site of the procedure
* Rheumatoid arthritis
* Amyloidosis or mucopolysaccharidosis
* Unable to communicate, cooperate or participate in follow-up
Quality of Life and Psychological Well-being in Patients With Malignant Melanoma

The purpose of this study is to analyse the physical and psychological side-effects in the course of treatment with IFN-alpha. The effectiveness of a specific intervention for the management of these side-effects is evaluated.

Today, the consideration of the side effects of intensive treatment measures and their influence on quality of life are regarded as standard procedures in oncology. Quality of life measurements have found their way into clinical studies as patient-reported outcomes. In comparison to other tumor types, the field of dermato-oncology has had less research activity concerning quality of life. However, in recent years more attention has been paid to health related quality of life in malignant melanoma patients, especially under adjuvant treatment with interferon-alpha. Data about high dose IFN-α treatment, especially from the USA, show that there are significant physical and psychological side effects, such as fatigue and depression, which often lead to dosage reduction or termination of treatment. As yet, there are very few systematic studies about low dose IFN-α treatment, especially in regard to the side effects during the course of the disease.

Concerning treatment side-effects it is known throughout various areas of oncology that specific psycho-oncological interventions assist in the patients' adaptation to the illness and handling of the side effects of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Documented and proven stage Ib up to stage IIIc malignant melanoma
* No clinical and radiological evidence or suspicion of persistent disease
* Treatment with IFN-α within a study or analog treatment schedule with IFN-α
* ECOG performance status \< 2
* Constant after care
* Informed consent to participate in the study
* melanoma diagnosis within the last 5 years or therapy, recurrence or progression within this period of time.

Exclusion Criteria:

* Inoperable lymph nodes- or distant metastases
* Tumors of other origins or localisations within the past 10 years
* Severe and permanent infectious diseases, e. g. HIV or hepatitis
* Participation in other treatment studies apart from IFN-α
* Insufficient knowledge of German language
Magnesium and Metabolic Syndrome

Objective : to test the BP lowering-effect of oral magnesium supplementation, as magnesium chloride (MgCl2) solution, 2.5 g daily, in uncomplicated hypertensive type 2 diabetic subjects with decreased serum magnesium levels Design : Randomised double blind placebo controlled trial. Setting : Outpatients with type 2 diabetes from Durango, city in northern Mexico Subjects : 82 subjects between 40 and 75 years of age with type 2 diabetes serum magnesium deficiency and uncomplicated hypertension.

Interventions : During 4 months the intervention group received 2.5 gr of magnesium chloride (50 ml of a solution containing 50 gr of MgCl2 by 1000 ml of solution ). Controls received inert placebo.

Main outcome measure: Change in blood pressure. Increase of serum magnesium Secondary outcomes measures: Changes in lipid profile


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Decreased serum magnesium levels
* Uncomplicated hypertension
* 40 and 75 years of age
* Men and Women

Exclusion Criteria:

* Chronic diarrhea
* Alcohol intake (equal or more than 30 g per day)
* Use of diuretics and/or calcium antagonists drugs
* Previous oral magnesium supplementation
* Ischemic diseases; AND
* Reduced renal function