cyrilzakka/clinical-trials huggingface dataset:
MOTIV Bioresorbable Scaffold in BTK Artery Disease

The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 36 months) outcome of the MOTIV™ Bioresorbable Scaffold (Reva Medical) in a controlled prospective investigation for the treatment of patients with rest pain or minor tissue loss (CLI) due to the presence of lesions of max 100mm in length at the level of the below-the-knee arteries.


Eligibility Criteria:
Inclusion Criteria:

* Patient is willing to comply with specified follow-up evaluations at the specified times
* Patient presenting with rest pain or minor tissue loss (Rutherford classification from 4 to 5)
* Patient is \>18 years old
* Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study - Patient has a projected life-expectancy of at least 24-months
* Patient is eligible for treatment with the MOTIV™ Bioresorbable Scaffold
* Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
* De novo lesion or Restenotic lesion after PTA in the infrapopliteal arteries, suitable for endovascular therapy
* Target vessel diameter visually estimated to be ≥2.5mm and ≤3.50mm
* Guidewire and delivery system successfully traversed the lesion
* Total target lesion is maximally 100mm
* Definition of Target Lesion is:

  1. short de novo or Restenotic lesion after PTA or
  2. a short residual flow-limiting dissection or restenosis after PTA of a longer lesion

Exclusion Criteria:

* The reference segment diameter is not suitable for the available stent design
* Untreated flow-limiting aortoiliac stenotic disease
* Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment.
* Any previous surgery in the target vessel
* Aneurysm located at the target vessel
* Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
* Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy.
* Major distal amputation (above the transmetatarsal) in the study or non-study limb.
* Septicemia or bacteremia
* Any previously known coagulation disorder, including hypercoagulability
* Contraindication to anticoagulation or antiplatelet therapy
* Known allergies to scaffold or scaffold components
* Known allergies to contrast media that cannot be adequately premedicated prior to the study procedure
* Patient with known hypersensitivity to heparin-induced thrombocytopenia (HIT) type II
* Currently participating in another clinical research trial
Prediction of Acute Pancreatitis Outcome

Aim of study prediction of acute pancreatitis outcome by using cheap and available laboratory resources

Acute pancreatitis (AP) is a sudden inflammation of the pancreas that can vary from mild, self-resolving episodes to severe, potentially fatal conditions(1). Clinically, AP is classified into mild acute pancreatitis and severe acute pancreatitis (SAP), and SAP patients are described by multi-organ failure and high mortality rates(2). The mortality rate of acute pancreatitis varies, ranging from 3% in cases of mild edematous pancreatitis to as high as 20% in patients with pancreatic necrosis(3).The progression of AP can lead to systemic complications, making early prediction of clinical outcomes essential for effective management(4).

In recent years, there has been growing interest in identifying reliable biomarkers that can predict the severity and outcomes of acute pancreatitis(5). Systemic inflammation is a key factor in the pathophysiology of acute pancreatitis, often leading to systemic inflammatory response syndrome (SIRS) and subsequent organ dysfunction(6). Consequently, assessing systemic inflammation has become a crucial aspect of managing AP patients(7).

The Systemic Inflammation Response Index (SIRI) is recognized in the literature as an inflammatory marker that combines routine blood parameters, such as neutrophils, monocytes, and lymphocytes(8). Both SIRI and the Systemic Immune Inflammation Index (SII) are emerging as novel biomarkers for systemic inflammation(9). SIRI is calculated using neutrophil, monocyte, and lymphocyte counts, while SII is based on platelet, neutrophil, and lymphocyte counts(10)

Eligibility Criteria:
Inclusion Criteria:

Patients age \>18 years old Serum amylase \>3 times the upper limit of normal. abdominal pain consistent with acute pancreatitis. Typical abdominal ultrasonography and tomography findings in the routine imaging of the patients were accepted as acute pancreatitis.

Patient complaint of abdominal pain -

Exclusion Criteria:

liver diseases patients renal diseases patients malignancy patients

-
Translation and Validation of BELA-p-K for QoL Evaluation in PD Patients

The BELA-P-k was translated from Dutch into Italian. Subsequently 102 patients with PD filled out the questionnaire

In order to provide an appropriate endpoint for the assessment of the effectiveness of rehabilitation treatments on QoL of PD patients, in this study we translated and then validated the Belastungsfragebogen Parkinson kurzversion (BELA-P-k). This tool allows evaluating separately two crucial aspects: i) the loss of personal autonomy in activities of daily life and ii) the psychological and psychosocial impact of the disease.

The BELA-P-k was translated from Dutch into Italian. Subsequently 102 patients with PD filled out the questionnaire. PD patients were also evaluated by using the Parkinson Disease Questionnaire -39 (PDQ39), the Unified Parkinson's Disease Rating Scale (UPDRS), the Mini Mental State Examination (MMSE) and the Frontal Assessment Battery (FAB) The internal consistency of the questionnaire was assessed by means of Cronbach's alpha coefficient.

The discriminant validity was assessed by testing for differences between mean values for patients grouped according to Hoehn and Yahr stages. This analysis was carried out by a one-way analysis of variance.

Finally, the construct validity was determined by assessing the relationship (Spearman rank correlation coefficient) between Bela-P-k and the PDQ39

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's Disease

Exclusion Criteria:

* any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous twelve months;
* other chronic diseases with a known impact in QoL.
* MMSE \< 24
Access to Healthcare, Patient Comprehension and Future Plans of Women Undergoing Surgery for a Vesicovaginal Fistula in Niamey, Niger

Evaluate access to healthcare, comprehension of pre-operative counseling and post-operative goals of women treated for vesicovaginal fistula in Niger through use of a questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Women who underwent surgery for repair or vesicovaginal fistula

Exclusion Criteria:

* None
Open Label Extension of TUDCA-ALS Study

This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.

The TUDCA-ALS Open label extension study is designed to investigate long term safety, tolerability and efficacy of tauroursodeoxycholic acid in patients with ALS who completed the TUDCA-ALS study

Eligibility Criteria:
Inclusion Criteria:

* Completion of the visit M18 (Month 18) of the TUDCA-ALS clinical trial.
* Signed informed consent for participation in the TUDCA-ALS Extension sub-study

Exclusion Criteria:

* Treatment with edaravone or other unaccepted concomitant therapy
* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive TUDCA or that the subject is unable or unlikely to comply with the dosing schedule or study evaluations
* The patient of reproductive potential is sexually active and is not willing to use highly effective contraception during the study and up to 90 days after the day of last dose
* The patient is pregnant or breast feeding
Minoxidil for Treating White Hair: a Randomized Controlled Trial

The goal of this clinical trial is to evaluate whether topical Minoxidil can restore hair pigmentation in individuals with non-pathological graying hair. The study population includes male and female participants aged \[18to65\] who have non-pathological graying of hair, meaning their graying is not due to any underlying medical conditions.

The main questions it aims to answer are:

Does topical Minoxidil improve hair pigmentation in individuals with non-pathological graying hair? What medical problems do participants have when topical use minoxidil? Researchers will compare participants receiving topical Minoxidil to those receiving a placebo to determine whether Minoxidil has a significant effect on restoring hair pigmentation.

Participants will:

Topical use minoxidil or a placebo twice a day for 12 months Visit the clinic once every months for checkups and tests Report any adverse effects or changes in hair characteristics throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* The patients included in the study were those with a visible gray hair grading score of 2 or higher at screening and baseline visits, with depigmented hair shafts observable under dermoscopy.

Exclusion Criteria:

* Exclusion criteria included various pathological types of gray hair (including, but not limited to, alopecia areata, albinism, radiation-induced gray hair, and vitiligo); any scalp skin diseases (including, but not limited to, androgenetic alopecia, folliculitis, seborrheic dermatitis, psoriasis, tinea capitis, and scalp sebaceous cysts); and any history of medication use or other treatments applied to the scalp within the past year (including, but not limited to, minoxidil, hair transplantation surgery, boric acid lotion, ketoconazole shampoo, and corticosteroid ointments). Patients with severe systemic diseases, immune diseases, endocrine disorders, or neurological diseases were also excluded.
A Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects.

The purpose of this study is primarily to evaluate whether taking avanafil with alcohol causes the blood pressure to fall.

The trial is a single-centre double-blind, randomized, placebo-controlled, three-period, three-way crossover study, in which each subject will be randomized to receive each of the following three treatments with a washout period of at least 5 days between treatments:

* Treatment A: a single oral dose of one 200 mg avanafil tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
* Treatment B: a single oral dose of one placebo tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
* Treatment C: a single oral dose of one 200 mg avanafil tablet plus an oral dose of placebo drink mixed with fruit juice.

For each treatment period, Dinamap (or DataScope) automatic measurements of supine blood pressure and pulse rate will be taken pre-dose and every 15 minutes for 4 hours post-dose. Alcohol levels using a breathalyzer will be measured at pre-dose and up to 8 hours post dose during all 3 treatments by designated unblinded personnel. Subjects should be supine for at least 5-10 minutes before the blood pressure and heart rate measurement.

Eligibility Criteria:
Inclusion Criteria:

* Adult male subjects,
* either 21 to 45 years of age,
* must be medically healthy with no clinically significant screening results.

Exclusion Criteria:

* Major exclusion criteria include: history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematological, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the investigator; systolic blood pressure \< 90 or \>150 mmHg; diastolic blood pressure \< 50 or \> 95 mmHg;
* allergy to or previous adverse events with PDE5 inhibitors, alcohol or their constituents; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days of Day 1 dosing (Period 1);
* use of any investigational drug within 30 days of Day 1 dosing (Period 1);
* use of any prescription or over-the-counter drugs or herbal remedies within 14 days of Day 1 dosing (Period 1);
* history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breath alcohol, positive cotinine test or positive urine drug screen at screening or on Day -1;
* positive serology for HIV, HCV, HBsAg. Additional exclusion criteria are listed in Section 4.2.
Post-Stroke Sensory Reweighting on Walking and Balance Outcomes

The primary objective of this proof-of-concept study is to longitudinally track the development of post-stroke sensory reweighting (PSR), identify associated structural neuroanatomical correlates, and investigate their relationship to walking and fall outcomes.

Post-stroke imbalance and walking impairment is a function of diminished sensorimotor integration, motor, and postural control. It impacts over 75% of stroke survivors, and remain a rising cause of falls, fractures, and death in the United States. The associated fear of falling often leads to a downward spiral of health, characterized by reduced walking performance, caregiver dependency, social isolation, and the development of secondary post-stroke medical complications. Although spontaneous biological recovery and intensive clinical rehabilitation may improve balance and walking ability, the extent of recovery is often limited after the first 6-months of stroke (chronic phase). Furthermore, currently available clinical measures such as the Berg Balance Scale and Timed-Up-and-Go lack the specificity and granularity needed to foster the development of individualized and targeted neurorehabilitation interventions. In addition, non-invasive neurostimulation strategies lack specificity due to limited understanding of the most appropriate neuroanatomical targets for optimizing sensorimotor integration. Hence there is an urgent need to identify reliable physiologic and neuroanatomic correlates in the earlier stages of recovery (\<6 months), to enable timely and targeted rehabilitation interventions.

Eligibility Criteria:
Inclusion Criteria:

1. First ever clinical stroke
2. Stroke due to ischemia
3. Age 18 years or older
4. Ability to consent by patient (not surrogate), any time prior to acute hospital discharge

Exclusion Criteria:

1. Pre-stroke dependence (modified Rankin Scale score of 3 or more)
2. Isolated brainstem or cerebellar stroke
3. Bilateral acute strokes
4. Co-enrollment in a trial of an intervention through six-month follow-up
5. Inability to maintain follow-up with study procedures through six-month follow-up
6. Contraindication to non-contrast MRI
7. Low likelihood of survival beyond the acute hospitalization, such as malignant cerebral edema
8. Pre-existing co-morbid conditions that significantly affects vision, somatosensory function, vestibular system, orthostasis, coordination or mobility
9. Post stroke mRS\>4 or discharge to hospice
Effects of Hysteroscopy and Transvaginal Surgery on Reproductive Prognosis in Patients With Post Cesarean Scar Defect

The study is to compare hysteroscopic repair and transvaginal intervention for correcting uterine defect in patients with post cesarean scar defect (PCSD) and the reproductive prognosis.

Post cesarean scar defect (PCSD), refers the lower uterine segment form a reservoir-like pouch during healing process after transverse lower uterine segment cesarean section connected with uterine cavity. The pouch has a valve-like effect, obstructing blood drainage and accumulating blood in depression. These causes may lead to a variety of gynecological disturbances, secondary dysmenorrheal and infertility. Some patients can occur some serious obstetric complications, such as cesarean scar pregnancy and even the rupture of uterus during a subsequent pregnancy. At present, the causes and mechanisms of PCSD are not clear, diagnosis and treatment are not uniform. Surgical methods include abdominal surgery, laparoscopic surgery, transvaginal surgery, hysteroscopic surgery, hysteroscopic with laparoscopic surgery and so on. Hysteroscopic and transvaginal surgery to treating PCSD both are minimally invasive and feasible surgical approach. However, hysteroscopic surgery and transvaginal surgery have not been compared for correcting the uterine defect in patients with PCSD before.

Eligibility Criteria:
Inclusion Criteria:

* Patients had a history of transverse lower uterine segment cesarean section;
* Patients had a previous regular menstruation, while after caesarean section, they occurred prolonged postmentrual bleeding (10-20days)
* Medication failed(contraceptive pills).
* Sex hormone test is normal;
* TVU or hysteroscopy showed a triangular or U-shaped anechoic liquid dark area and on the anterior lower uterine segment in relation to cesarean section scar during menstruation of 7-12 days or hysteroscopic examination showed uterine anterior wall defect like dome changes at isthmus below internal orifice of cervix.

Exclusion Criteria:

* Irregular menstrual cycle before cesarean section
* Previous placement of an intrauterine contraceptive device
* Presence of other organic uterine pathology responsible for abnormal uterine bleeding, such as endometrial hyperplasia, polyps or submucosal myomas, cervical cancer, endometrial cancer, etc
* Existence of endocrine diseases, such as dysfunction of pituitary, ovarian, adrenal gland, and thyroid;
* Coagulation dysfunction.
Hyaluronic Acid and Uterine Synechiae

The primary purpose of the study is to compare efficiency of a non-stick gel application after scraping surgery for natural miscarriage with no non-stick gel application after scraping surgery.

Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8 weeks after surgery.

Women patients coming for natural miscarriage will be compared according to whether a non-stick gel will be applicated or not after scraping surgery.

6-8 weeks after this surgery uterine synechiae rate will be established at a diagnostical hysteroscopy. Proofreading of this exam will be made by 2 experts at the end of the study without knowing the randomization arm.

Long-term follow-up of the patients will be performed to evaluate the effect of the non-stick gel application on post-surgical fertility at 6, 12, and 24 months after scraping surgery using questionnaire asked by post, mail or phone.

Eligibility Criteria:
Inclusion Criteria:

* Women patients aged between 18 and 46 years old
* Term ≥ 7 weeks amenorrhea and ≤ 14 weeks amenorrhea
* Blighted ovum or not completed miscarriage or haemorrhagic miscarriage or retention miscarriage
* Consent signature
* Social security coverage
* Women who wants to be pregnant

Exclusion Criteria:

* Infected miscarriage
* Uncertain diagnosis between miscarriage and extra-uterine pregnancy
* Hydatiform mole
* Uterine synechiae history
* Surgical zone infection
* Hyalobarrier® gel Endo hypersensitivity
* Clotting disorder
* Unstable diabetes
* Maternal malignant diseases
* Psychiatric disorder
* Incapacity in understanding the consent form and the questionnaires
* Law protected adult person
To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients

The study will assess the analgesic efficacy and safety and tolerability of a single oral dose of SAF312 in postoperative dental pain patients after 3rd molar extraction.


Eligibility Criteria:
Inclusion Criteria:

* Extraction of two or more impacted (partial or full) third molars. At least one of the impaction should be lower jaw.
* Each patient will evaluate her/his post-surgical pain intensity prior to taking trial medication.
* To be eligible for this trial, post surgical pain must be moderate to severe -- Subjects should be in good health otherwise as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening.
* Female subjects should be either postmenopausal or should have had surgical sterilization.

Exclusion Criteria:

* Patients with known hypersensitivity to diclofenac, aspirin, acetaminophen or to antipyretics or with allergies manifested by attacks of asthma, urticaria or acute rhinitis following treatment with aspirin or other agents with cyclooxygenase-inhibiting activity such as NSAIDs.
* Use of antipyretic/analgesic drugs from 48 hrs pre-dose to 24 hrs postdose
* Presence of bleeding disorder (history of excessive bleeding after dental procedures or minor injuries)
* Patients with Diabetes mellitus.
* Presence, history of, or family history of malignant hyperthermia or anesthesia-related events that may be suggestive of malignant hyperthermia.
* An abnormal ECG at screening, including PR\>200 ms, QRS\>110 ms, QTcF\<380 or \>450 ms, lead II T wave abnormalities. Non-specific T wave abnormalities in leads other than lead II are permissible if not accompanied by any other morphological abnormalities.
* Patients with infection e.g. dental abscess

Other protocol-defined inclusion/exclusion criteria may apply
Prospective Longitudinal Cohort Study of Vasculitis Patients

VASCO is a prospective observational cohort study which aim to describe the presentation, comorbidities, management, outcomes and damage of vasculitis patients, from the analysis of the clinical, biological and immunological data.

Vasculitis is a group of disorders characterized by the inflammation of blood vessels, leading to an alteration of the vascular wall. The classification of vasculitides has evolved considerably over the last few decades.

In 1990, the American College of Rheumatology established a classification of the main systemic vasculitides based on clinical, biological and histological criteria. In 1994, the Chapel Hill nomenclature has been established as the reference classification system of vasculitides and vasculitides were classified according to the size of the affected vessels. The Chapel Hill nomenclature was revised in 2012, thus enabling to integrate new vasculitides and diagnostic tools.

It is proposed here to conduct a non-interventional cohort study of the different forms of vasculitis, as defined in the Chapel Hill nomenclature. By collecting data from a large number of patients followed prospectively, our objective is to describe the clinical patterns of these diseases, the presentation, management, comorbidities and outcomes, and to evaluate their possible association with some immunological, genetic and molecular parameters.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age over 18 years),
* Patients with vasculitis, as defined in the Chapel Hill International Nomenclature as revised in 2012,
* Patients included at an active phase of the disease, either the initial flare or a relapse,
* Patients who have been informed and have signed the consent
* Pregnant and breastfeeding women may be included in the study,
* Affiliated to a social security system (beneficiary or entitled person).

Exclusion Criteria:

* Refusal of consent or inability to obtain consent,
* A patient who is insane or not entitled, for psychiatric reasons or intellectual impairment, to receive information about the protocol and to give informed consent,
* Patient under guardianship / curators
* Patient on state medical assistance (AME)
* Hemoglobin less than 7 g/dl at the time of sampling,
* Hemoglobin level less than 9 g/dl at the time of sampling if the patient has respiratory or cardiovascular disease,
* Patient weighs less than 18 kg.
* Parallel participation in an interventional protocol is permitted.