cyrilzakka/clinical-trials huggingface dataset:
An Open Label Study of CM-AT for the Treatment of Children With Autism

This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.

Autism is clearly a significant cause of disability in the pediatric population. Treatment is based on the observation that many children with autism do not digest protein. CM-AT is a proprietary enzyme that is designed as a granulated powder taken three times daily.

Eligibility Criteria:
Inclusion Criteria:

* Age between 3 and 8 years, inclusive, at the time of signing informed consent/assent in Sponsor 00103 Study
* Completion of the Sponsor's 00103 Study who continue to meet eligibility requirements
* Currently in the 00102 open label study and continue to meet eligibility requirements
* Subjects who initially qualified for 00103 screening, who subsequently failed Baseline entrance criteria for randomization (@Visit 1) Baseline assessment of the ABC eligibility requirement who continue to meet eligibility requirements
* Up to 20 subjects 9-17 years of age who directly enroll into this study, who meet the current Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR) diagnostic criteria for Autistic Disorder (AD), screened by the SCQ and confirmed by the ADI-R

Exclusion Criteria:

* Patient weighing \< 13kg
* Allergy to porcine products
* Previous sensitization or allergy to trypsin, pancreatin, or pancrelipase
* History of severe head trauma, as defined by loss of consciousness or hospitalization, skull fracture or stroke.
* Seizure within the last year prior to enrollment, or the need for seizure medications either at present or in the past.
* Evidence or history of severe, moderate or uncontrolled systemic disease
* Ongoing dietary restriction for allergy or other reasons except nut allergies. Lactose free is allowable but not dairy free.
* Inability to ingest the study drug / non-compliance with dosing schedule.
* Inability to follow the prescribed dosing schedule.
* Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 5 days prior to the initial randomized study period.
* Subjects taking an selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days prior to entering the study.
* History of premature birth \<35 weeks gestation.
* Prior history of stroke in utero or other in utero insult.
Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)

The purpose of this phase III study is to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Patients with Osteoarthritis of the Knee


Eligibility Criteria:
Inclusion Criteria:

* Medical history and symptoms of knee osteoarthritis

Exclusion Criteria:

* Any other disease or medication affecting the bone or cartilage.
* Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.

Other protocol defined inclusion/exclusion criteria may apply
Sensory Changes From Chest Drains

Does chest drains contribute to the post thoracotomy pain syndrome


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Able to cooperate
* able to speak and read Danish

Exclusion Criteria:

* repeat surgery
* cognitive dysfunction
* other nerve injury on the thorax
* abuse (medicine/ alcohol etc)
Double Lock Versus Continuous Non-locking Technique for Closure of Rectus Sheath in Cesarean Sections on Post-operative Pain

In this trial we compare the effect of 2 closure techniques of the rectus sheath during cesarean sections on postoperative pain. One closure technique is double lock technique and the other is the conventional continuous non-locking technique.


Eligibility Criteria:
Inclusion Criteria:

* first cesarean section

Exclusion Criteria:

* urgent cesarean section
* previous abdominal surgery
* previous cesarean section
* obstetric and medical complications
Diabetes Type 2 in the Eastern Region of Morocco

This South Initiative is the first step towards a long-term general objective that aims to improve the manage-ment of type 2 diabetes (T2D) and concurrently create jobs for health professionals in Eastern Morocco by developing a multidisciplinary approach in the management of T2D, based upon international guidelines but adapted to the regional socio-economic and cultural context, and with a focus on empowerment of Muslim women.

The intermediate results of this SI project proposal are: 1) Facilitators and perceived barriers in female patients with T2D towards change to a healthier lifestyle are known. 2) Characteristics of patients with T2D in the region of Oujda (prevalence, lifestyle, age, gender,...) are analysed. 3) Master and bachelor students have gained experience by participating to relevant research. 4) All involved stakeholders shared existing and newly ac-quired knowledge and expertise. 5) Facilitators and perceived barriers in health professionals of different disciplines to work together in the management of T2D are known.

The ultimate objective is to help improve the quality of life and well-being of people living with diabetes in the Oujda region.

This 2-year project will tackle the prerequisites and optimise the conditions needed to start a larger (TEAM) project. Afterwards, in the larger long-term (TEAM) project we will study the cost-of illness of T2D in Oujda, the effect of a cultural-sensitive multidisciplinary intervention for T2D and the cost-effectiveness of such an intervention. In doing so we hope to provide not only arguments from a health perspective for such an approach, but also from a quality of life and economic point of view. This is needed to persuade political decision makers to invest in sustainable innovation in health care. This could open the job market for many young physiotherapists, nutritionists and occupational therapists in health centres and primary care.

The specific objectives of this 2-year SI project are 1) to know the characteristics of T2D patients in Oujda and their perceived barriers and benefits towards participation in a lifestyle program and 2) to improve communication and cooperation between health professionals of different disciplines treating patients with T2D.

The intermediate results of this 2-year project are well defined and feasible (Annex 4). The two years of the SI project will be devoted to gathering information from diabetic women as well as from health profes-sionals, to creating a platform and to strengthening research capacities. The changes needed to reach the SI project outputs are related to 1) knowledge/capacity and 2) attitude/behaviour.

Eligibility Criteria:
Inclusion Criteria:

* women
* visiting the 35 local health centres and the CRD in Oujda
* adult
* Moroccan

Exclusion Criteria:

* male
* no informed consent
Plasma Rich in Growth Factors in the Preservation of the Alveolar Ridge After Simple Molar Tooth Extractions.

This Randomized Clinical Trial aims to study the efficacy and safety of PRGF-Endoret in alveolar ridge preservation after single molar extractions. The control group is the spontaneous healing occuring after the suturing of the alveolus. The primary endpoint is the bone regeneration measured in biopsies obtained from the regenerated alveolar bone.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Clinical indication for simple tooth extraction in the posterior sectors (from the second premolar to upper and lower second molars)
* Need to place a dental implant in the same position of the extraction
* Availability of observation during the period of treatment
* Signature of the informed consent

Exclusion Criteria:

* Third molars
* Active periodontal disease
* Simultaneous extraction of two adjacent pieces in the same quadrant
* Oral dehiscence ≥ 25%
* Alveolus depth \<7mm
* Loss of some wall of the alveolus
* Severe inflammation in the extraction area
* Previous diagnosis of coagulopathies
* Previous diagnosis of autoimmune disease
* Be receiving, or have received the 30 days prior to extraction treatment with radiotherapy, chemotherapy, immunosuppressants, systemic corticosteroids or anticoagulants
* Regular treatment with NSAIDs
* History of chronic hepatitis or liver cirrhosis
* Positive markers for HCV, AfHBs, HIV-I / II or TP
* Diabetes mellitus with poor metabolic control (evidence of glycated hemoglobin\> 9%)
* Dialysis treatment
* Presence of malignant tumors, hemangiomas or angioma in the extraction area.
* History of ischemic heart disease in the last year
* Pregnancy or women of childbearing age who do not take action contraceptives
* Lactating women
* Previous diagnosis of metabolic bone disease
* Antiresorptive treatment
* Treatment with monoclonal antibodies
* Smoker\> 10 cigarettes / day
* Any inability to participate in the study
Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases

The main purpose of the study is to establish a relationship between the administered activity of the radioiodine and absorbed dose in the tumor sites.

Study Design - the assessment of patients with multiple tumour sites with metastatic thyroid cancer to correlate the administered activity to absorbed dose. Patients will receive the standard therapy dose of 5.5 GBq as per the hospital policy and there will be no change for the protocol purpose.

Eligibility Criteria:
Inclusion Criteria:

* age above 18
* histological confirmation of the differentiated thyroid carcinoma available
* WHO performance score 0-2
* metastatic sites lung and/or bone and/or nodal (radiologically measurable disease \> 1 cm)
* life expectancy \> 6 months
* patient has undergone total/near total thyroidectomy
* no past history of sensitivity/reaction to 1311

Exclusion Criteria:

* non iodine concentrating tumours
* received chemotherapy or radiotherapy in 6 weeks
* pregnant or breast feeding patients
* iodine contrast injection in last 3 months
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy

The purpose of this clinical study is to quantify the difference in thermal injury depth at the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to subjectively assess histopathologic sample quality metrics; to examine the role that electrosurgical artifact may play in revision lumpectomy procedures; and to compare these endpoints to the standard of care (SOC) technology.

Lumpectomy is a surgical procedure performed to remove a localized mass of breast tissue that is suspicious for malignancy. The purpose of lumpectomy is to minimize the amount of tissue removed from the breast to retain normal breast architecture while simultaneously removing all of the suspected cancerous tissue. Typically, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away any cancerous tissue.

The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the pathological analysis of excised breast lumps.

This single site study was granted Institutional Review Board (IRB) approval and conducted between June 2009 and January 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were then required to provide informed consent prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PEAK PlasmaBlade study groups and scheduled for lumpectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 90 years old
2. Physically healthy, stable weight
3. Requiring lumpectomy with wire localization for suspected or confirmed malignant breast disease.
4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
5. Subject must be willing and able to comply with all follow-up evaluations

Exclusion Criteria:

1. Age younger than 18 or greater than 90 years old
2. Infection (local or systemic)
3. Cognitive impairment or mental illness
4. Severe cardiopulmonary deficiencies
5. Unable to follow instructions or complete follow-up
6. Currently taking any medication known to affect healing
7. Currently enrolled in another investigational device or drug trial
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma

This is a comparative study using resected/ biopsied tumors samples collected from renal cell carcinoma and urothelial carcinoma patients who underwent surgical removal of lesions, followed by immune checkpoint blockade (ICB) treatment targting programmed cell death 1 (PD1) but developed new lesions later were also removed and stored in the biosample repository (BSR). The histology and genomic analysis of the pre-treatment and metastatic samples from the same patient would be used to find out the changes that may have lead to metastasis. Also, metastatic samples from ICB naive patients would be collected and compared with those from ICB treated patients to find out if the metastasis in treated patients was due to development of reistance.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will include retrospectively identified patients with RCC or UC who have received treatment with ICB and achieved clinical benefit but subsequently developed a solitary new/progressive lesion that was removed surgically. Patients with other tumor types who otherwise meet criteria may be included at a later time
* Additionally, a group of patients with RCC who have undergone a metastasectomy but who did not receive treatment with ICB will be identified. These patients may be approached for study participation to serve as a comparator group

Exclusion Criteria:

-
Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC

This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).

This is a single-center, prospective study to evaluate the efficacy and safety of lenvatinib, sintilimab plus SIRT (Len-Sin-SIRT) in patient with unresectable HCC.

30 patients with unresectable intermediate-advanced HCC (BCLC B/C stage) will be enrolled in this study. The patients will receive lenvatinib (body weight ≥60kg, 12mg; body weight \<60kg, 8mg; P.O. QD) and sintilimab (200mg I.V. Q3W) at 3-7 days after SIRT. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Lenvatinib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.

The primary end point of this study is Progression free survival (PFS) per mRECIST. The secondary endpoints are PFS per RECIST 1.1, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

* Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically
* At least one measurable untreated lesion
* Intrahepatic tumors can be treated with 1-2 session of SIRT
* Child-Pugh score 5-7
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
* Life expectancy of at least 3 months
* Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL
* Patients with hepatitis C need to finish the anti-HCV treatment

Exclusion Criteria:

* tumor extent ≥70% liver occupation
* Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
* Vena cava invasion
* Central nervous system metastasis
* Metastatic disease that involves major airways or blood vessels
* Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy, or immunotherapy for HCC
* History of organ and cell transplantation
* Prior esophageal and/or gastric varices bleeding
* History of hepatic encephalopathy
* Peripheral blood white blood cell count\<3×10\^9/L, platelet count\<50×10\^9/L
* Prolongation of prothrombin time ≥ 4 seconds
* Severe organ dysfunction (heart, lungs, kidneys)
* History of malignancy other than HCC
* HBsAg and anti-HCV antibody positive concurrently
* Human immunodeficiency virus (HIV) infected
Staphylococcus Aureus Caught in Action at the Site of Infection

This study is to obtain a comprehensive view of S. aureus adaptations in the infected human host and (i) to improve the understanding of the interface between antibiotic therapy, resistance development and virulence factor adaptation in S. aureus infected patients, and (ii) to adapt these findings into a more sustainable use of antimicrobials for therapy.

Staphylococcus (S.) aureus is notorious for its ability to develop resistance. This study is to obtain a comprehensive view of S. aureus adaptations in the infected human host and (i) to improve the understanding of the interface between antibiotic therapy, resistance development and virulence factor adaptation in S. aureus infected patients, and (ii) to adapt these findings into a more sustainable use of antimicrobials for therapy.

Patients with S. aureus infections who will routinely undergo diagnostic and surgical procedures will be identified. Intraoperative samples from the site of infection during surgery will be taken. Additionally, two blood drawing events (22.5ml in total) will be performed and nose swabs will be taken. The biological material will be analysed. This project will be the first to study different phenotypes of invasive S. aureus directly from its environment in vivo.

Eligibility Criteria:
Inclusion criteria for patients:

* In collaboration with the orthopedic surgeons, patients with probable or proven S. aureus infections will be identified who will routinely undergo diagnostic and surgical procedures:

Inclusion criteria for healthy participants:

* Healthy control group should be generally well-being

Exclusion criteria for patients and for healthy participants:

* Pregnancy: Pregnant or lactating women will be excluded (urinary pregnancy test will be performed in women of childbearing age)
* General health condition: Current or recurrent disease that could cause complications that may affect the study or may set the patient at risk
* Diseases/ Illness: Psychiatric or other mental disorders which in the opinion of the investigator may probably affect the full understanding of the study (including signs of dementia)
* Language: Insufficient knowledge of german language to understand the procedure and rationale of the research question
* Vulnerability: Individuals whose willingness to volunteer in the research project may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, such as members of a group with a direct hierarchical structure (refer to ICH Guidelines E6 (R1) for GCP, 1.61)
Drugs Brain and Behavior (DDP)

In this project, we will examine individual differences in the effects of a stimulant drug, methamphetamine (MA), on mesolimbic reward function using fMRI.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 19 and 26
* Right Handed
* Less than 4 alcohol or caffeinated beverages a day.

Exclusion Criteria:

* High blood pressure
* Any medical condition requiring regular medication
* Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
* Individuals with a history of dependence on stimulant drugs
* Women who are pregnant or trying to become pregnant.
A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121

Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects.

The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-212-A compared with AD-2121 in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
* Negative result from Serum Helicobacter pylori antibody at the time of screening visit

Exclusion Criteria:

* Patients with trouble performing Gastric pH monitoring
Surgical Outcomes, Quality of Life and Patient's Satisfactions With Phalloplasty

The phalloplasty is a reconstruction technique, consisting of the neophallus creation.

It is performed in transgender patients in sex reassignment surgery, or in cismale patients to correct a congenital or acquired lack of penis.

There are many surgical techniques, but none is optimal. Surgical and functional outcomes, quality of life and patient's satisfactions with phalloplasty are missing in the international literature.

Urological center of Lyon is a reference center of this kind of surgery and has the possibility to evaluate that.

In this study, 124 transgender and 19 cismale patients with phalloplasty are eligible.

This study will allow us to adapt our practice to the patient's return and improve the information given to patients before their surgery.

It will also improve our surgical techniques, depending on the results achieved.


Eligibility Criteria:
Inclusion Criteria:

* Major patients
* Patients who have undergone a phalloplasty surgery in the University Lyon Sud Hospital or Croix Rousse Hospital, between 1 January 2007 and 31 October 2018
* Patients with at least one year of back on their surgery procedures
* Transgender patients whose reassignment surgery was validated by a minimum of three members of GRETTIS (Groupe de Recherche, d'Etude et de Traitement des Troubles de l'Identité Sexuelle), including a psychiatrist Or Patients cis males with congenital malformations, or having suffered a total or partial amputation of verge
* Patients who do not oppose orally to participate in the study, after information
* Patients who have given their consent for the audio recording for patients taking part in semi - directive interviews

Exclusion Criteria:

* Minor patients or patients under legal protection
* Refusal to participate in the study
* No understanding of the French language