cyrilzakka/clinical-trials huggingface dataset:
Genetics of Ankylosing Spondylitis

Ankylosing spondylitis (AS) is a chronic inflammatory disease that affects the joints between the vertebrae of the spine and the joints between the spine and the pelvis. The purpose of this study is to collect information and blood samples from patients with AS and their relatives for use in genetic studies.

AS is a chronic inflammatory disease that eventually causes the affected vertebrae to fuse or grow together. The cause of AS is unknown, but genetic factors seem to play a role. Risk factors include a family history of ankylosing spondylitis and male gender.

This study will collect patient information and blood samples from affected patients (and when available, both parents of the affected patients) of 400 families with children fulfillling the modified New York criteria for AS. Diagnosis of AS will be verified by patient questionnaire, medical record review, and pelvic radiographs. Information from these patients will be used to search the human genome for disease-associated loci and/or genes. This study will also utilize contributions of investigators who have conducted recent clinical or genetic research in AS at 10 academic medical centers throughout North America (the North American Spondylitis Consortium, or NASC).

Eligibility Criteria:
Inclusion Criteria:

* Meet modified New York criteria for ankylosing spondylitis (AS)
* AS as confirmed by X-rays of sacroiliac joints (between the pelvis and spine)
* At least two siblings in family with AS
* Parents of the participants with AS have the option of also being enrolled
Validation of a New Score for UGI Bleeding in the ED: the Study of the TU-GIB Score

We have developed a new reliable, easy and reproducible clinical and biological score to select patients presenting to the emergency department with upper GI bleeding and at high risk of developing complications in order to plan an adequate management.

This score was compared to the Glasgow-Blatchford score and showed better results in predicting rebleeding, the need for hemostasis therapy and any complications at day 30 including mortality.

In a second step and as an objective of this study, it is necessary to perform an external validation of this score in different emergency departments.

We have developed a new reliable, easy and reproducible clinical and biological score to select patients presenting to the emergency department with upper GI bleeding and at high risk of developing complications in order to plan an adequate management.

This score was compared to the Glasgow-Blatchford score and showed better results in predicting rebleeding, the need for hemostasis therapy and any complications at day 30 including mortality.

In a second step and as an objective of this study, it is necessary to perform an external validation of this score in different emergency departments.

We will conduct a multicenter, descriptive and analytical study in different emergency departments Inclusion criteria: patients consulting the emergency department for upper GI hemorrhage of non-traumatic origin.

Exclusion criteria: patients under 18 years of age, diagnosed with external hemorrhoids with parietal lesions. We exclude any patient who does not consent, is lost to follow-up or has incomplete information.

Anonymity and confidentiality of the data were respected. Data collection was carried out using a data processing form designed for the purpose of this work, including descriptive analysis of the epidemiological and clinical characteristics of the patients, as well as the para-clinical data.

Patients were followed up by telephone call at D30 to record the date and cause of any complications noted, such as rebleeding, hospitalization, or death.

The data will be entered and analyzed in SPSS 21.0

Eligibility Criteria:
Inclusion Criteria:

* patients consulting the emergency room for upper GI hemorrhage of non-traumatic origin.
* Age \>18 years

Exclusion Criteria:

* patient under the age of 18
* Lower gastrointestinal hemorrhag
* diagnosis of external hemorrhoids / perianal lesions
* Not consenting
* The lost sight
Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing caesarean section.

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, few studies had been indicated the ED50 (prevent postspinal hypotension in 50% of patients) and ED90 of prophylactic norepinephrine bolus and its potency compared to phenylephrine for postspinal anesthesia hypotension in patients undergoing caesarean section. The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing caesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)
* Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months
* Pain score at least 4 in 4 of 7 days prior to receive treatment.

Exclusion Criteria:

* Pregabalin use in the last 60 days, prior intolerance to pregabalin
* Creatinine clearance \<60 mL/min.
* White blood cell count \<2500/mm3; neutrophil count \<1500/mm3; platelet count \<100 x 103/ mm3.
* Abuse of drugs or alcohol
* Unstable medial conditions
* Clinically significant abnormal electrocardiogram (ECG).
* Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.
Detection of Plasma DNA in Non Small Cell and Small Cell Lung Cancer Patients

The majority of lung cancer patients have a tumor-derived genetic alteration in circulating plasma DNA that could be exploited as a diagnostic tool. The aim of this study is to evaluate if plasma DNA can be used as a valuable non invasive test to monitor disease progression without assessing the tumor.


Eligibility Criteria:
Inclusion Criteria:

* Presence of lung tumor to use fiberoscopy or surgical intervention for diagnosis.
* No lung instability.
* Individuals give all informed consent
Reliability and Validity of the Turkish Version of the PedHAL

This study aimed to establish the validity and reliability of the Turkish version of the Pediatric Haemophilia Activities List (short - PedHALshort) questionnaire.

Hemophilia is a blood disease characterized by a bleeding disorder that develops due to the deficiency of clotting factor VIII (Hamophilia A) or coagulation factor IX (Hamophilia B) proteins that provide clotting in the blood. In the hereditary disease showing X-linked recessive inheritance, female individuals are carriers and male individuals show a clinical picture. Although the clinical picture changes depending on the duration and frequency of bleeding, the severity of the disease is classified as severe, moderate and mild. Musculoskeletal problems are the most common complications in patients with severe and moderate hemophilia. Hemarthroses due to bleeding in the joint (80%) and hematomas due to intramuscular bleeding (20%) cause joint degeneration and muscle atrophy. Recurrent hemarthroses occur when there is not enough clotting factor in the setting, often before the previous hemarthrosis has resolved. This creates a vicious cycle of bleeding-inflammation-rebleeding known as the "target joint". The resulting vicious circle causes permanent damage to bone and cartilage structures and causes "arthropathy". The knee is the joint region where hemarthrosis and arthropathy are most common, followed by the elbow and ankle joints. Since these joints in the musculoskeletal system contain more synovial tissue than the others, they are more exposed to trauma and load and are injured. As a result of all these, pain, joint limitations and muscle strength losses occur. All these clinical findings lead to a decrease in functional independence in activities of daily living with the restriction of physical activity in patients.

In the literature, there are questionnaires and measurement methods in which many functional evaluations are made for hemophilia patients. However, most of them have not been validated and reliable in Turkish. For this purpose, our study aimed to establish the validity and reliability of the Turkish version of the Pediatric Haemophilia Activities List (PedHALshort) questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with Hemophilia by a physician (Factor VIII-IX)
* Ages 4-17 years old
* Receiving regular prophylactic treatment
* Children who volunteered to participate in the study and whose family consent was given

Exclusion Criteria:

- Children with neurological signs that limit activities of daily living
Clinical Characteristics, Natural History, Health Care Measures, and Genetic Screening in Patients With ALS

Patients with sporadic ALS (sALS), which refers to those without a family history of ALS, are typically not subjected to genetic investigations as part of their standard care. Therefore, their mutation status is often unknown. Even patients with familial ALS (fALS), who have a known family history of ALS, are not regularly screened for genetic mutations. This project aims to study a large group of ALS patients, examining their family history, clinical characteristics, healthcare measures, and genetic variants in ALS's most commonly mutated genes: SOD1, C9orf72, FUS, and TARDBP. Examining genetically distinct ALS cohorts is significant, as understanding the relationship between genotype and disease progression is essential in determining the therapeutic potential of future genetic therapies.

Only limited data are available on the frequency of genetic variants in patients with sporadic ALS (sALS) and familial ALS (fALS). Genetic investigations do not belong to the standard of care in patients with sALS (patients without a family history of ALS). As a result, the patient's mutation status is commonly unknown. Even in patients with fALS (with a known family history of ALS), screening for genetic mutations is not performed regularly due to lacking treatment options in gene therapy. However, this paradigm is about to change as clinical trials on genetic medicines are ongoing and might result in the approval of new genetically investigated drugs. This project aims to explore a large cohort of ALS patients on family history, clinical characteristics, healthcare measures, and genetic variants in SOD1, C9orf72, FUS, and TARDBP - the most commonly mutated genes in ALS. This cohort study will allow us to determine the frequency of gene mutations in ALS patients in a real-world setting of ALS centers in Germany. Furthermore, the project shall enhance insights into potential differences between genetically defined cohorts using the course of the disease and the provision of health care measures. The investigation of genetically distinct ALS cohorts is particularly relevant, as an improved understanding of the relationship between the genotype and the journey of disease is scientifically indispensable to determine the therapeutic potential of future genetic therapies.

Eligibility Criteria:
Inclusion Criteria:

* ALS, including classical ALS, Progressive Muscle atrophy (PMA) or Primary Lateral Sclerosis (PLS)
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) under national and local subject privacy regulations
* Age of 18 years old at the time of informed consent

Exclusion Criteria:

* Inability to provide patient directives about the notification of individual study results on genetic variants of SOD1, C9orf72, FUS and TARDBP
* Inability to comply with study requirements
* Unspecified reasons that, in the opinion of the site investigator, perceive the subject as unsuitable for enrollment
Bevacizumab Versus Combined Bevacizumab and Triamcinolone for Refractory Diabetic Macular Edema; a Randomized Clinical Trial

The purpose of this study is to compare the efficacy and safety of intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory diabetic macular edema.

According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema is laser therapy, which may be neither effective nor curative in some patients. Corticosteroids may have a beneficial effect on diabetic macular edema. Other newly introduced medications for macular edematous lesions are anti-VEGF vascular endothelial growth factor)drugs. In this randomized, sham-controlled, multicenter, three-arm clinical trial,we try to evaluate the safety and efficacy of intravitreal bevacizumab alone and in combination with intravitreal triamcinolone in the treatment of refractory diabetic macular edema.

Eligibility Criteria:
Inclusion Criteria:

* Cases with clinically significant macular edema (CSME) with persistent retinal thickening after initial or supplemental macular photocoagulation

Exclusion Criteria:

* Monocularity,
* History of vitrectomy,
* Glaucoma or ocular hypertension,
* Significant media opacity,
* Existence of traction on the macula
Stellarex Vascular E-Registry

Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients intended to be treated with Stellarex for de-novo or restenotic lesions of the femoro-popliteal arteries
* Rutherford Clinical Category (RCC) 2-3 or 4 indicated for a Percutaneous Transluminal Angioplasty according to local applicable guidelines
* Age ≥18 years old
* Life expectancy \> 1 year
* Is able and willing to provide written informed consent prior to enrollment in the study (as applicable)
* Is able and willing to come on site or to be contacted by phone for the follow-up

Exclusion Criteria:

* Patients with any medical condition that would make him/her inappropriate for treatment with Stellarex as per Instructions for Use (IFU) or investigator's opinion
* Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints
* Patients that in the judgment of the investigator would need treatment below the knee before and/or during the index procedure.
A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.


Eligibility Criteria:
Inclusion Criteria:

* Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31

Exclusion Criteria:

* Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31
Observational Study in Patients Treated with JAK Inhibitors for Inflammatory Rheumatism (MAJIK)

Janus kinase (JAK) inhibitors are a new class of molecules available to the therapeutic arsenal for chronic inflammatory rheumatic diseases.The tolerance profile of this new class needs to be better defined and its use in real life further established.

The French Society of Rheumatologists intends to coordinate a prospective national registry study for this follow-up.

This registry will include at least 1500 Rheumatoid Arthritis (RA) and 150 patients with psoriatic arthritis from the start of treatment with JAK inhibitor and then followed for 5 years.

This registry is a longitudinal, multicentre, observational registry study. The objective of this national registry is to get a better understanding of the safety profiles of JAK inhibitors and get knowledge of their use in daily practice in order to optimize this use and potentially integrate JAK inhibitors into personalised medicine strategies.

This registry will generate efficacy data, especially therapeutic maintenance, observation, allowing inter-registry comparisons with other biologic compounds in the French population, and can be aggregated with other similar registries in other countries.

Design:

This registry is a longitudinal, multicentre, observational registry study, with continuous and ambispective collection of clinical and laboratory data. The patients will be followed for 5 years, regardless of the therapeutic modifications occurring thereafter.

Target population:

Patients initiating JAK inhibitor therapy for inflammatory rheumatic disorder.

Number of patients and centres :

* The objective is to include, per drug available on the market, at least 300 to 500 patients with RA and at least 100 to 150 patients with psoriatic arthritis. If a JAK inhibitor is approved in a new indication of chronic rheumatic disease by European Medicines Agency (EMA), the number of patients to include for each molecule in this indication will be adjusted as a function of the prevalence/epidemiology of each disease. Products currently available (baricitinib and tofacitinib) will be considered at the start of this registry; then every new indication for an already approved drug or every new drug in the same therapeutic class starting from the date they are placed on the market will be considered.
* More than 80 centers in France (hospital-based, public and private practice) will participate.

Eligibility Criteria:
Inclusion criteria

* Patients older than 18
* Patient treated with a JAK inhibitor in accordance with EMA, for chronic inflammatory rheumatisms, independent of the therapeutic line
* Subject who is a member of a social security regime
* Free, declared, written consent signed by the subject and the investigator on the day of inclusion Exclusion criteria
* Patient who cannot understand the implications and rules of the study
* Patient opposition to participating in the study
Female Sling Procedure

In trans-obturator tape (TOT), tension and location of the tape in mid urethral zone are directly related to the postoperative clinical outcome. Recurrence of symptoms of stress urinary incontinence has been related to tape migration in previous studies. The study aimed to increase the success rate of TOT procedure through a new surgical technique using a 2 paramedian vaginal incisions.

the investigator innovated a new technique that involves a 2 paramedian vaginal incisions that allow more tape stabilization with sparing the dissection along the whole urethra ensuring intact overlying tissues and to create a tunnel in between the 2 incisions to pass the tape, making it supported proximally and distally with normal undissected tissues.

the study aims to assess the success rate of TOT and tape migration using a new surgical technique versus the standard procedure using vertical incision.

Eligibility Criteria:
Inclusion Criteria:

* adult female patient complaining of pure stress incontinence confirmed by stress test of urodynamic study

Exclusion Criteria:

* Patients with neurological disease, pelvic organ prolapse, previous urethral or pelvic floor surgery will be excluded from our study.
A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura

To test the effectiveness of recombinant human CD4 Immunoglobulin G (CD4-IgG) in the treatment of HIV-associated immune thrombocytopenic purpura in patients with all levels of HIV infection.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Dapsone at a constant dose level and only as a prophylaxis for Pneumocystis carinii pneumonia (PCP).
* Zidovudine (AZT) at a constant dose for the 12 weeks of treatment, except if AZT-related toxicity is observed.

Patients must have the following:

* HIV seropositive (asymptomatic, AIDS-related complex, or AIDS).
* HIV-associated immune thrombocytopenic purpura.
* The ability to sign a written informed consent form, which must be obtained prior to treatment.
* A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
* Patients currently on zidovudine are not excluded. However, the zidovudine dose level must remain constant for 4 weeks prior to entry and for the 12 weeks of treatment, except if zidovudine related toxicity is observed.
* A life expectancy of at least 3 months.

Prior Medication:

Allowed:

* Dapsone at a constant dose for more than 2 weeks prior to study entry.
* Zidovudine at a constant dose for 4 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

* Active serious opportunistic infection (excluding positive block cultures of Mycobacterium avium complex or Cytomegalovirus).
* Malignancies other than Kaposi's sarcoma.
* Tumor-associated edema.
* Visceral Kaposi's sarcoma.
* Significant neurologic, cardiac, or liver disease.

Concurrent Medication:

Excluded:

* Ganciclovir (DHPG). Pyrimethamine. Clindamycin. Sulfadiazine. Folinic acid. Prednisone. Intravenous gamma globulin. Intravenous acyclovir. Interferon. Systemic corticosteroids. Non-steroidal anti-inflammatory drugs (NSAIDs). Known immunomodulatory agents. Dideoxycytosine. Dideoxyinosine. Nucleoside analogs (with the exception of zidovudine or topical acyclovir). Any experimental therapy.

Patients with the following are excluded:

* Active serious opportunistic infection (excluding positive block cultures of Mycobacterium avium complex or Cytomegalovirus).
* Malignancies other than Kaposi's sarcoma.
* Kaposi's sarcoma requiring therapy.
* Tumor-associated edema.
* Visceral Kaposi's sarcoma.
* Significant neurologic, cardiac, or liver disease.
* Conditions requiring excluded concomitant medications.
* Herpes virus infection requiring intravenous acyclovir.

Prior Medication:

Excluded for a minimum of 4 weeks prior to study entry:

* Chemotherapy.
* Immunomodulatory agents.
* Any experimental therapy.

Prior Treatment:

Excluded for a minimum of 4 weeks prior to study entry:

* Radiation therapy.
* Any experimental therapy.