cyrilzakka/clinical-trials huggingface dataset:
Comparison of Different De-epithelialization Techniques of Soft Tissue Grafts.

In this randomized comparative controlled clinical trial, 50 patients with single recession defects with thin phenotype were treated with coronally advanced flap. The connective tissue graft was obtained by removing the keratinized layer of the tissue. Removal of the epithelium was achieved by to different approach. At first group epithelium and remnants were removed extraorally whereas others were intraorally. After the removal, obtained graft laid on a lamella, and residual keratinocytes were observed under the microscope. Amount of recession reduction recorded at the 6th week, 6th month, 12th month, and keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were also evaluated. Keratinized tissue change, Gingival thickness change, root coverage, clinical attachment gain, and complete root coverage were calculated. Wound healing index, tissue appearance, patient expectations, aesthetics, and dentine hypersensitivity were assessed at baseline and 6th week.


Eligibility Criteria:
Inclusion Criteria:

* Single tooth recession more than 2mm
* Gingival thickness less than 1mm

Exclusion Criteria:

* unstable endodontic conditions or presence of any restoration/abrasion,
* tooth mobility, any surgical history or gingival enlargement in the area,
* smoking
* uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions
Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)

The objective of this study is to allow treatment with the sirolimus-eluting Bx VELOCITYTM stent in patients with a serious disease or condition for which there is no generally acceptable alternate treatment available.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female patient minimum 18 years of age
2. There is no alternative treatment for this patient as determined by the treating physician and an uninvolved cardiac surgeon;
3. Target lesion is 2.50mm and 3.50mm in diameter (visual estimate);
4. Target lesion is 45mm in length (visual estimate), treated with a maximum of three 18 mm stents;

Exclusion Criteria:

1. There is currently another method of treatment for the patient, including coronary artery bypass surgery (CABG) or brachytherapy;
2. The study target lesion has definite or possible thrombus present by angiographic criteria.
Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI)

Ninety-nine individuals meeting the study's inclusion/exclusion criteria will be enrolled in this study. The objective of this study is to evaluate three different therapeutic approaches to synergistically retrain functional movement patterns of the upper extremities in combination with trunk stabilization to promote neurologic and functional recovery after SCI. Each subject will complete 40 sessions of intervention. Subjects will also complete a Baseline Evaluation (week 0), Re-Evaluation (week 4), Post Treatment Evaluation (week 8), and a Follow-Up Evaluation (week 12).


Eligibility Criteria:
Inclusion Criteria:

* History of traumatic SCI
* Less than 5months post SCI
* SCI injury level C1-C8
* SCI categorized as AIS B-D
* Currently receiving inpatient rehabilitation at Craig Hospital
* Passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows
* Demonstrate motor response to electrical stimulation in majority of UE muscle groups below level of injury (tested during screening)
* No complicating physical or cognitive conditions (as determined by their physician) that would preclude safe use of electrical stimulation
* Able to complete study as an outpatient if discharged from inpatient rehabilitation before completing 40 sessions of training

Exclusion Criteria:

* Unstable chronic cardiac or respiratory complaints
* Current or history of UE contracture or skin pressure injuries that might interfere with intervention
* Received Botox injections within the last 3 months
* Pregnant
* Implanted devices including: pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intra-thecal pump.
Applicability of Syncope Guidelines in Cataluña

The aim of SYNCAT study is to study the level of adherence of the centers in Cataluña tu the Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact that following them can have in the prognosis of these patients.

The aim of SYNCAT study is to analyze the level of adherence of Syncope Guidelines ESC2009 for the management, diagnosis and treatment of syncope in a specific territory with similar health structure, the region of Cataluña in Spain that includes aprox. 7,000,000 inhabitants, including different complexity level of hospitals and the impact that following guidelines can have in the prognosis of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Each patient that comes from the Emergency room and/or in office doctors visit (Internal Medicine, Cardiology, Neurology...) with Transient Loss of Conscience (T-LOC)

Exclusion Criteria:

* Patients younger than 15 years old
* Pregnant women
Efficacy of Brock String Therapy Post Concussion

The purpose of the proposed study is to evaluate the efficacy of Brock String therapy prescribed in the acute stage of concussion recovery can improve clinical outcomes among patients with receded near point of convergence (NPC).

Aim 1: Determine if participants receiving the Brock String have more significant improvements in NPC measurements at follow up 7-10 days post injury.

Aim 2: Determine if participants receiving the Brock String 1) improve on computerized neurocognitive test scores from initial visit (\<48 hours post injury) to follow up visit (7-10 days post injury) compared to control participants, and 2) have reduced recovery time (i.e., days from injury until return to play) compared to control participants.

Receded near point of convergence (NPC) is a common oculomotor deficit associated with numerous vision diagnoses, including convergence and accommodative insufficiencies, following sport-related concussion (SRC). Researchers have found associations with worse neurocognitive test scores, higher post-concussion symptom burden, and longer recovery among patients with receded NPC relative to concussion patients with normal NPC. Although oculomotor dysfunction may resolve spontaneously or improves with vision therapy exercises in the post-acute phase of recovery, it is unclear if early intervention can improve recovery outcomes. The Brock String is a cost effective and practical vision therapy exercise for congenital convergence insufficiency (CI), and initial research supports effectiveness with SRC patients who have receded NPC in the subacute phase of recovery (e.g., weeks to months post injury). Early vision therapy intervention may be efficacious in improving recovery times and reduce healthcare costs by eliminating later therapies for chronic deficits.

Eligibility Criteria:
Inclusion Criteria:

* Athletes who sustained a concussion during organized sport within past 48 hours
* ages 12-20
* at least one NPC measurement \>10 centimeters at initial clinic evaluation.

Exclusion Criteria:

* lack of access to a smart phone to receive text message prompts
* vestibular disorder
* seizure disorder
* history of traumatic brain injury with imaging findings or brain surgery
* history of 3+ concussions\\
* concussion within the past 6 months
* history of developmental or intellectual disability
* history of substance abuse
* Patients will also be excluded from recruitment if the treating clinician feels the potential participant would be unable to tolerate Brock String therapy due to severe symptoms
Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss

This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate female pattern hair loss with ongoing hair loss for at least 1 year
* Willingness to have micro-dot-tattoo applied to scalp
* Willingness to maintain same hair style, length and hair color during study

Exclusion Criteria:

* Drug or alcohol abuse within 12 months
* HIV positive
* Received hair transplants or had scalp reductions
* Use of hair weaves, hair extensions or wigs within 3 months
* Oral or topical minoxidil treatment within 6 months
* Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Validation of a Method to Search Residual Disease in Auto-cryopreserved Ovarian Tissues

Cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who have to undergo sterilizing gonadotoxic treatment, with the aim of preserving their fertility. The main part of the ovary is preserved, as primordial and primary follicles are resistant to freezing / thawing protocols. In the absence of other techniques (in vivo maturation, injecting isolated ovarian follicles, etc.) autografting this cryopreserved tissue is currently the only technique allowing fertility to be restored. Autograft is possible only if the indication for ovary cryopreservation is a non-neoplastic pathology or a malignant pathology with a low risk of ovarian metastasis. In other cases of neoplastic pathologies, particularly in cases of acute leukemia, tissue cannot as yet be re-used due to the lack of any codified technique for evaluating residual disease (MRD). The team has for two years been developing and validating a technique to look for residual disease in fragments of ovarian cortex in cases of acute leukemia. This technique is based on an original protocol for dissociating ovarian tissue to obtain a population of isolated ovarian cells that may be analyzed by multicolor flow cytometry. The specificity and sensitivity of the technique have been demonstrated in an experimental model. This model consists in using 8 color flow cytometry to look for characterizable leukemia cells added in different dilutions to a population of isolated ovarian cells taken from model ovarian cortex and up to a dilution of 10-5. When the molecular markers were present on diagnosis, they were found by Real-Time Quantitative Polymerase Chain Reaction (RQ-PCR) with the same dilutions. The model tissue came from laparoscopic ovarian drilling in patients with polycystic ovary syndrome. The main objective of this project is to validate techniques that have been previously codified with different populations of leukemia cells that may be characterized. The investigators then aim to adapt and validate this technique to look for MRD using 8 color flow cytometry on cryopreserved fragments of ovarian cortex from leukemia patients that are at risk of metastasis. Secondary objectives will be to implement procedures for oncological qualification of grafts in cases of malignant pathology and to consider the recommendations for using this cryopreserved ovarian tissue through the autograft technique for these indications.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have cryopreserved their ovarian tissue
* Patients with premature ovarian insufficiency
* Patient aged from 18 to 43 years for the restoration of ovarian function
* No objection from the patient

Exclusion Criteria:

* Patients Under 18 years
* Patients older than 43 years
* Patients refusing to be included
* Patients (adults) Under guardianship, curators ans safeguard justice
Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease

The primary objective is to document the safety of tecemotide (L-BLP25) phase III formulation in non-small cell lung cancer (NSCLC) subjects with unresectable Stage III disease. This population includes Stage IIIA NSCLC subjects, a population not studied in former clinical studies with this vaccine. The secondary objective is to document the survival of subjects treated.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented unresectable stage III NSCLC. Mediastinal (N2) involvement must be confirmed by biopsy
* Stable disease or clinical response after primary therapy of chemo-radiation treatment for unresectable stage III disease
* Primary therapy should be a minimum of 2 cycles of Platinum-based first-line chemotherapy, given concurrent with thoracic radiation. The combined modality should consist of either:

  * induction (2 cycles) chemotherapy followed by concurrent chemo-radiation therapy; or
  * concurrent chemo-radiation therapy followed by 2 cycles of consolidation chemotherapy; or
  * concurrent chemoradiation therapy alone
* A minimum radiation dose of greater than or equal to (\>=) 6,000 centigray (cGy) should be administered. Subjects must have completed the primary therapy at least 4 weeks and no later than 6 months prior to study entry
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (\<=) 1
* Ability to understand and willingness to sign a written informed consent
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Undergone lung cancer specific therapy (including surgery) prior to primary chemo-radiation therapy
* Received immunotherapy/systemic immunosuppressive drugs/investigational systemic drugs within 4 weeks prior to study entry
* Subjects with brain metastases, pleural effusion, unless cytologically confirmed to be non-malignant
* Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
* Autoimmune disease or immunodeficiency
* Clinically significant hepatic, renal dysfunction or cardiac diseases
* Clinically significant active infection
* Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator
* Other protocol defined inclusion criteria could apply
Volumetric Imaging Follow up of Patients With Liver Metastases of Small Intestinal Neuroendocrine Tumors (NETs).

More than 50% of intestinal NETs are metastatic at the time of diagnosis, the liver being the main affected organ in 50-90% of cases.

Initial liver tumor burden and slope of the tumor growth rate are two major prognostic factors in patients with intestinal NETs, followed by tumor grade at pathology. They are used in routine practice by oncologists to adapt patient treatment.

Unlike other tumors, most NETs metastases are slow-growing tumors. Previous studies have shown that approximately half of the patients diagnosed with liver metastases showed no progression over a period of 3 to 6 months.

The aim of this non randomised retrospective cohort study is to investigate whether the volumetric monitoring of the total tumor burden compared to the RECIST 1.1 criteria (used in routine practice by radiologists) at baseline and early follow-up (3 to 6 months) is more suitable for NETs, making possible to predict the prognosis at the onset of the disease, and also allowing a better adaptation of the treatment.

The secondary objectives are to evaluate if the initial volume of the liver tumor is a prognostic factor of time to progression, to correlate the initial liver tumor volume and the number of liver lesions to the blood concentration of Chromogranin A (CgA), the presence of extra-abdominal disease and to correlate the tumor growth rate (TGR) and KI 67 (%) at base-line.


Eligibility Criteria:
Inclusion Criteria:

* Well differentiated intestinal neuroendocrine tumor with at least one liver metastasis
* The liver metastasis must be visible and measurable on CT scans or MRI
* Patients monitored without invasive liver treatment : surgery, RF ablation / Trans-arterial chemoembolization
* Patients monitored without systemic treatment such as: Chemotherapy, Everolimus, Sunitinib (Somatostatin analogues allowed)
* Surgery of the primary tumor allowed

Exclusion Criteria:

* Other type of NETs
* Absence of liver metastases
* Liver metastases not visible on CT scans/MRI, poorly limited lesions and small target lesions ( less than 10mm) that are difficult to measure
* Lesions visible only on diffusion-weighted imaging -MRI acquisitions, thus presenting poorly limited contours
* Invasive liver treatment : surgery, Radio frequency / Trans-arterial chemoembolization
* Systemic treatments: Chemotherapy / Everolimus / Sunitinib
* Insufficient follow-up data
Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure

Automated quantification of the pulmonary volume impaired during acute respiratory failure could be helpful to assess patient severity during COVID-19 infection or perioperative medicine, for example.

This study aim at assessing the correlation between the amount of radiologic pulmonary alteration and the clinical severity in two clinical situation :

1. SARS-CoV-2 infections
2. Postoperative hypoxemic acute respiratory failure


Eligibility Criteria:
Inclusion Criteria:

* patient with insurance covering
* patient admitted to the participating hospitals for SARS-CoV-2 infection or postoperative acute hypoxemic respiratory failure between 01/01/2019 and 05/11/2020

Exclusion Criteria:

- patient transferred to another hospital than the participating center during the 7 days following the CT scan
A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants

The purpose of this study is to characterize the single dose pharmacokinetics (PK) and evaluate the safety and tolerability of subcutaneous administration of rilpivirine (RPV) long-acting (LA) or RPV LA in combination with cabotegravir (CAB) LA extended release suspensions in different conditions in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (based on the average value of triplicate ECGs) performed at screening (results must be available on Day -1)
* Participant must be healthy on the basis of clinical laboratory tests performed at screening (results must be available prior to dosing on Day 1). If there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
* All women participants must have a negative highly sensitive serum (Beta-human chorionic gonadotropin \[Beta-hCG\]) pregnancy test at screening and on Day -1
* A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for at least 72 weeks after receiving the dose of study intervention
* A male participant (not vasectomized) who is heterosexually active with a woman of childbearing potential must agree to use two effective contraceptive methods for the duration of the study (72 weeks follow-up), or for at least 72 weeks after receiving the dose of study intervention for those who do not complete the study

Exclusion Criteria:

* Participant with a history of or current illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study intervention to the participant or that could prevent, limit or confound the protocol specified assessments. This may include, but is not limited to, hepatic or renal dysfunction, cardiac disease, vascular, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, neurologic, hematologic, coagulation disorders (including any abnormal bleeding or blood dyscrasias), or psychiatric disturbances
* Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
* Participant has known allergies, hypersensitivity, or intolerance to Cabotegravir (CAB) or its excipients
* Participants with the following ECG findings, if clinically significant: abnormal PR, QRS, and QTc intervals; rhythm abnormalities; evidence of acute ischemic changes
* Participants with a history of clinically relevant skin disease such as, but not limited to, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria
Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611

The study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and therefore the levodopa area-under-the-concentration-curve values, half-life, and trough concentrations The study will help determining the safety and tolerability of ND0611 and determine the pharmacokinetic profile of levodopa following multiple oral dosing of levodopa/carbidopa (LD/CD) and continuous delivery of ND0611


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian males between 18 and 50 years (inclusive) of age
* Normal body weight
* Subjects with negative urinary drugs of abuse, HIV, Hepatitis B or Hepatitis C serology tests
* Subjects must be able to adhere to the protocol requirements
* Subjects must provide written informed consent to participate in the study.
* Haemoglobin level \>12.5 mg /dl

Exclusion Criteria:

* History of significant psychiatric disorder, neurological diseases or sleep disorders
* History of significant systemic diseases, by medical history or tests performed during screening examinations
* Clinically significant laboratory tests at screening
* History of drug or alcohol abuse.
* Allergy to levodopa, carbidopa or any inactive component of the test formulation.
* Subjects with dark skin
* Subjects with skin diseases or neoplasms
* Subjects with narrow-angle glaucoma
* Subjects with significant allergic response to other drugs.
* Subject with known atopic disorders
* Known allergy or hypersensitivity to adhesive tapes.
* Use of any prescription or over-the-counter (OTC) medications
* Subjects who donated blood or received blood, in the last 3 months
* Participation in another clinical trial in the last 30 days
* Subjects which do not have the ability to communicate well or will not adhere to the protocol procedures
GI Interlab 2 Study: Measuring the Glycaemic Index (GI) of Foods

The purpose of this study is to assess the extent of and sources of variation in the glycaemic index values of foods measured by different laboratories around the world.

The glycaemic index values of 3 different foods provided from a central location will be determined in each of 20-30 centers around the world. A standard protocol will be followed, but this protocol leaves room for variation in certain details, such as whether subjects are allowed to have coffee or tea with the test meals or only water, or the method of analyzing blood glucose. Methodologic details, subject demographic information (height, weight, age, and ethnicity), results of local calculations and raw data will be sent to a central location.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects

Exclusion Criteria:

* Diabetes
* Pregnancy or lactation