cyrilzakka/clinical-trials huggingface dataset:
Observational Study of the Use of octaplasLG®.

This observational study enrolls patients who have received at least one infusion of octaplasLG®. OctaplasLG® will be administered standard of care and observation occurs during the treatment and 24 hours after the end of treatment. Characteristics of the use of octaplasLG®, tolerance criteria, and efficacy criteria will be collected.

Prospective, non-interventional, multicentre study meeting a post-marketing need. The data will be collected in all patients who have received at least one infusion of octaplasLG®.

The duration of follow-up is limited to the duration of treatment with octaplasLG® plus 24 h of monitoring after cessation of treatment.

Characteristics of the use of octaplasLG® (indication for the transfusion, degree of urgency, characteristics of plasma infusions, patient characteristics, number of iso-group and/or compatible units administered, tolerance criteria (adverse effects), and efficacy criteria (for patients with confirmed diagnosis of TTP--time to normalization of platelet count) will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is treated with octaplasLG® (receiving at least 1 unit of 200 ml octaplasLG®)
2. In accordance with Reference Methodology MR-003, the patient of legal age must be individually informed through an information sheet, and must not oppose participating in this non-interventional study (with no collection of consent). If the patient is unable to receive the information and express any opposition, family members or the trusted person receive the information and must not oppose the collection of data\*. For minor patients, one of the holders of parental authority receive the information and must not oppose the collection of data.

   * However, the patient in question will be informed if his/her condition later allows.

Exclusion Criteria:

1) Patient's refusal to participate
Magnesium and Ketamine in Postoperative Analgesia

90 female patients scheduled for cancer breast surgeries will be assigned to 2 groups, each of 45. Group (K) will receive a bolus of 0.5 mg/kg ketamine with induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour continued till 24 hours after surgery. Group (KM) will receive a bolus of 0.5 mg/kg ketamine added to 50mg/kg magnesium sulfate over 30 minutes after induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour added to 8mg/kg/hour of magnesium sulfate continued till 24 hours after surgery. The same anaesthetic regimen will be applied to all patients. Total intraoperative fentanyl required to maintain mean blood pressure within 20% of its baseline will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. In the follow-up visits after 3 months, all patients will be assessed for neuropathic pain by DN4 questionnaire.

90 female patients aged between 18 and 65 years, scheduled for cancer breast surgeries will be assigned to 2 groups, each of 45. Group (K) will receive a bolus of 0.5 mg/kg ketamine with induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour continued till 24 hours after surgery. Group (KM) will receive a bolus of 0.5 mg/kg ketamine added to 50mg/kg magnesium sulfate over 30 minutes after induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour added to 8mg/kg/hour of magnesium sulfate continued till 24 hours after surgery. The same anaesthetic regimen will be applied to all patients. Total intraoperative fentanyl required to maintain mean blood pressure within 20% of its baseline will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. In the follow-up visits after 3 months, all patients will be assessed for neuropathic pain by DN4 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients with class II physical status (American Society of Anaesthesiologists) ,
* Age between 18-65 years,
* Scheduled for breast cancer surgery (e.g. modified radical mastectomy and conservative mastectomy)

Exclusion Criteria:

* Patient refusal,
* Cardiac dysfunction (ejection fraction \<45%),
* Diabetic patients
* Patients with uncontrolled hypertension
* Patients have any degree of heart block
* Patients have renal impairment (creatinine \> 2 mg/dl),
* Patients have hepatic dysfunction (transaminases \> 2 times normal),
* Patients with preexisting neurological or psychiatric disease,
* Patients who are allergic to one of the study drugs,
* Patients with communication difficulties,
* Inability to use the patient controlled analgesia (PCA) device,
* Female patients who are pregnant
* Patients who use preoperative calcium channel blockers or narcotic drugs.
Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine

This study will assess the efficacy and safety of the single pill combination of Aliskiren and Amlodipine in patients with moderate hypertension not adequately responding to a single pill combination of Olmesartan and Amlodipine.

Further this study will also assess the efficacy and safety of a single pill combination of Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension not adequately responding to a single pill combination of Aliskiren and Amlodipine.


Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension stage II
* Male and female patients
* Age \>= 18 years old

Exclusion Criteria:

* Severe hypertension (systolic BP \>= 180 mmHg, diastolic BP \>= 110 mmHg
* Poorly controlled diabetes mellitus or type 1 DM
* History of myocardial infarction, stroke
* Presence of heart failure
* Other protocol-defined inclusion/exclusion criteria may apply
Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia microparticles with or without laser in the treatment of moderate to moderately-severe inflammatory acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 15 - 45 years of age
* Able to provide informed consent/assent; minors will provide assent while parent or legal guardian will provide consent
* Moderate to moderately severe (3 or 4) inflammatory acne vulgaris by Investigator's Global Assessment
* Subject has 25 to 75 inflammatory lesions on the cheeks, chin and forehead, not concentrated in one area
* Subject has Fitzpatrick skin phototype I, II or III
* Subject is in good health, willing to participate and able to comply with protocol requirements

Exclusion Criteria:

* Severe acne (Investigator's Global Assessment 5) with significant scarring potential and greater than 2 nodular lesions
* Clinically relevant history of keloids
* Facial tattoos
* Acne conglobata, acne fulminans, chloracne, drug-induced acne
* Active concomitant skin disease, excessive scarring or excess facial hair
* Heavily tanned skin; unable or unwilling to avoid tanning beds/excessive sun exposure
* Acne medication and therapy restrictions - time period prior to Baseline (below)

  1. Oral retinoids - 6 months
  2. Other systemic medications - 4 weeks
  3. Topical retinoids, steroids, antibiotics - 2 weeks
  4. OTC topical treatments - 1 week
  5. Light treatments (including IPL or laser), microdermabrasion and/or peels - 8 weeks
  6. Investigational drug, biologic or device - 30 days
  7. Gold therapy of any type for any reason - EXCLUDED
* Pregnant, lactating, nursing or planning to become pregnant during the study period
* Known allergy to gold, ethanol, diisopropyl adipate, Polysorbate 80
* Clinically relevant condition that makes participation unsafe or that would interfere with study treatment and assessment
HES Patch Versus Blood Patch

The injection of autologous blood Blood Patch (BP) into the epidural space is the standard treatment for headache associated with intracranial hypotension. It provokes cerebral vasoconstriction. It is cons-indicated in a number of situations (HIV positive, fever, sepsis, leukemia). The purpose of this study is to evaluate another technique using a patch made by injecting an epidural hydroxyethylstarch solution (HES 130, 0.4, 6%) instead of blood patch. This alternative technique is simple to implement and does not have some of the specific blood pressure contra-indications. The study aims at comparing the "Blood Patch" group versus the "HES Patch" in terms of clinical efficacy , tolerance, satisfaction of the anesthetist, ease of implementation and effect of the injection of epidural anesthesia on cerebral blood flow within 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Subjects older than 18 years.·
* Subjects with an intracranial hypertension syndrome secondary to an epidural, spinal or lumbar puncture (and therefore presumed iatrogenic) with a sub arachnoid space or subjects with intracranial hypertension syndrome of primitive origin requiring treatment with epidural Patch ·
* subjects with a temporal window of sufficient quality to carry out the transcranial Doppler ·
* Subjects haven read the informed consent, signed and dated prior to the start of any proceedings related to the tial·
* Subjects affiliated to health insurance·
* Subjects having been informed of the results of a prior medical consultation

Exclusion Criteria:

* Subjects with a cons-indication to an epidural Patch:
* blood disorders constitutional or acquired coagulation with platelets
* Subjects under treatment with curative doses of antiplatelet drugs or anticoagulants
* subjects under shock and / or hypovolemia
* subjects under generalized sepsis or at the puncture site
* any other cons-indication to performing an epidural
Comparison of Open and Closed Chain Exercises in Athletes With Patellofemoral Pain Syndrome

Patellofemoral pain syndrome (PFPS) is a common source of knee pain in the physically active population, predominantly in women. The incidence rate of PFPS among athletes is 25 percent, which is higher than that of general population. PFPS is caused by repetitive stress and aggravated in athletes by cycling and running. These symptoms are caused by structural or biomechanical changes of the joint, which becomes exacerbated by activities such as going up and down stairs, sit for a prolonged period, squatting or kneeling, resulting in increased compressive forces in the joint patellofemoral. It is characterized by defused pain in front of knee. Other signs also present are the patellar crepitus, swelling, and joint blockage despite being deemed a multifactorial condition with no single cure, PFPS is commonly attributed to muscular dysfunction, for which conservative rehabilitation is the treatment of choice. Historically, PFPS has been linked to impairments of the quadriceps muscle.

This study will be a randomized clinical trial will be conducted in Pakistan sports board Lahore, Model town Sports Club Lahore and Sheikh Zaid Hospital, Lahore. Sample size will be taken to evaluate the effects of open chain exercise and closed chain exercise among athletes with an age group of 18 - 40 years. Non probability convenient sampling technique would be used. Players having an experience of at least 8 months would be a part of study experiencing recurrent knee pain. Participants will be randomly assigned to 2 groups. Group A will include participants who will receive open kinetic chain exercises 3sets of 10 repetitions for each exercise along with the general training. Group B will include the participants who will receive closed kinetic chain exercises 3sets of 10 repetitions for each exercise along with general training.3sessions per week will be given for 6weeks.The subjects will be assessed for pain, function and balance at baseline and after 6weeks of treatment. After collecting data from defined settingit will be entered and analyzed using statistical package for social sciences (SPSS) for Windows software, version 25.

Eligibility Criteria:
Inclusion Criteria:

* Adult athletes with age 18 to 30 years
* Anterior Knee pain
* An insidious onset of symptoms not related to trauma.
* Pain with compression of patella.
* Pain on palpation of patellar facets.
* Experienced players (who are in practice from last 8 months or a year).

Exclusion Criteria:

* Symptoms present less than 1 month.
* Intra-articular knee pathologies like O.A, R.A etc
* History of knee surgery within last year.
* History of traumatic injuries like patellar dislocations or subluxation
* Any other lower extremity injuries.
A Novel Technique for Prediction of Preterm Birth: Fetal Breathing Patterns

Preterm birth refers to a delivery that occurs before 37 weeks of gestation. Identification of those who will eventually deliver in the preterm period is very important. However, few interventions have been proven to prolong pregnancy in women at risk such as cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length measurements. In a meta-analysis comparing fetal breathing with cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length measurements, absence of fetal breathing was superior to other methods for prediction of preterm birth in 48 hours or 7 days. In this study, the investigators hypothesized that if a fetus holds its breath in case of preterm birth, then there may be specific fetal breathing patterns during preterm labor, which may be detected by ultrasonography

Preterm birth refers to a delivery that occurs before 37 weeks of gestation and it is the leading cause of neonatal morbidity and mortality. 33% of prenatal hospital admissions are due to preterm labor but almost 50% of patients receiving tocolytics in order to prevent birth deliver in the term period. Therefore, identification of those who will eventually deliver in the preterm period is very important. Ideally, identification of modifiable and nonmodifiable risk factors for preterm birth in will lead to interventions that help prevent this complication. However, few interventions have been proven to prolong pregnancy in women at risk such as cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length measurements. Another method for preterm birth prediction is presence of fetal breathing. In a meta-analysis comparing fetal breathing with cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length measurements, absence of fetal breathing was superior to other methods for prediction of preterm birth in 48 hours or 7 days. In this study, the investigators hypothesized that if a fetus holds its breath in case of preterm birth, then there may be specific fetal breathing patterns during preterm labor, which may be detected by ultrasonography

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients between 24-37 gestational weeks with preterm labor : Uterine contractions ≥4 in number in 20 minutes or ≥ 8 in number in 60 minutes and one of the following:
* Cervical dilation ≥ 3 cm
* Transvaginal cervical length \<20mm

Exclusion Criteria:

* Multifetal pregnancy
* Cervical dilation \> 5 cm
* Heavy vaginal bleeding
* Non-reassuring fetal non-stress test
* Preterm premature rupture of membranes
* Intrauterine growth restriction
* Oligohydramniosis
* Fetal anomaly
* Patients who received tocolytics for preterm labor or corticosteroids for lung maturation
* Drug or substance use which may depress fetal breathing
Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances

The purpose of this project is to study the influence of light on sleep, wakefulness, EEG activity and cognitive performances. The study aim also to evaluate techniques for registration and analysis of the EEG over periods of time.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18 to 40 years
* With a hint of Bodymass index (BMI) between 17 and 30 kg.m - 2
* Healthy subject determined by a clinical examination, a psychological interview, a blood test, a urine analysis and an ophthalmologic examination
* Topic Subject with a score \<6 questionnaire PSQI ("Sleep Questionnaire Pittsburgh")
* Subject agreeing to maintain a regular sleep/wake rhythm during the study
* Subject agreeing to refrain from caffeine, nicotine, alcohol, psychotropic drugs, cannabis or other drugs during the study
* Signed informed consent
* Subject affiliated to a social protection scheme

Exclusion Criteria:

* somatic diseases: cardiovascular, respiratory, gastrointestinal, hematopoietic, Visual
* immune system diseases
* kidneys and urinary tract diseases
* endocrine and metabolic diseases
* neurological diseases
* infectious diseases
* thrombocytopenia or other malfunction of blood platelets
* Subject with risk of thrombosis, including subject with a history of phlebitis, smoker under oral contraceptive...
* Subject with an addiction to caffeine, nicotine, alcohol, psychotropic drugs, cannabis, or any other drug
* Subject treatment contraindicated or inadvisable in combination with heparin
* Allergy to neoprene or lycra
* Dysfunction of the temporomandibular joint (TMJD)
* Blood donation in the previous 3 months before the inclusion
* Participation in other clinical trials in the previous 3 months before the inclusion
* Work by shifts in the year preceding the inclusion
* Trans-meridian travel (\> 2 time zones) in the month previous the inclusion
* Contraindications to the use of the medical device
* Impossibility to give enlightened information (subject in an emergency situation, understanding difficulties,...)
* Subject under safeguard of justice
* Subject under tutorship or curatorship
* Pregnancy (women of childbearing age)
* Breastfeeding
Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine

Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in people with HIV infection. Chloroquine is used worldwide and is quite inexpensive outside of the United States. If shown to be effective, chloroquine could be a very important tool worldwide in delaying HIV disease progression which would extend the time period without needing anti-retroviral therapy. In countries where anti-retroviral therapy is not available, this could be very helpful.

This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws for CD4 counts, HIV viral loads, and other research tests. The visits are at study enrollment, 4 weeks, and 8 weeks.

Summary:

A phase I randomized, double-blind, placebo controlled trial to investigate the efficacy of chloroquine to decrease T-cell activation and decrease viral load in early HIV.

Scientific Rationale:

Chloroquine has in vivo direct anti-HIV effects and an anti-inflammatory effect. These properties may be beneficial in reducing viral burden and immune activation therefore delaying HIV disease progression.

Sample Size: 25

Length of Study: 8 weeks, \[enrollment + 2 follow up visits\].

Intervention:

* Arm 1a: Chloroquine 250mg orally once daily for 8 weeks.
* Arm 1b: Chloroquine 500mg orally once daily for 8 weeks.
* Arm 2: Placebo once daily for 8 weeks.

Measurements:

* Blood draws at weeks: 0, 4, and 8 weeks.
* CD4, viral load measurements will be communicated to the referring provider (with subject consent).

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected adults
* CD4 count \> 250 cells/mm3
* Not presently receiving HIV antiretroviral therapy (\> 6 months or naïve)
* Viral load \> 3000 RNA copies/mL (3.5 log)
* No planned HIV anti-retroviral therapy for 8 weeks

Exclusion Criteria:

* Prior retinal eye disease
* CD4 \< 250 cells/µL
* Renal failure
* Active malignancy
* Corticosteroid therapy
* Age \< 18 or \> 65 years
A Study for the Disrupted Interpersonal Interaction Among Gaming Disorder Individuals and Treatment

Aiming at the major problems of unclear brain mechanism of gaming disorder and lack of effective assessment intervention tools, this project started by exploring the brain mechanism of abnormal interpersonal interaction and cognitive control deficit promoting and accelerating the development of gaming disorder, adopted a prospective cohort study design, combined with multi-modal brain functional imaging, cognitive function, social psychological assessment, and other means. To clarify the brain mechanism and outcome of gaming disorder. Based on the preliminary stage, for high-risk groups, risky gaming behavior, gaming disorder layout hierarchical multidimensional assessment intervention system, using science education, brief intervention, social psychological intervention, neural regulation, cognitive rehabilitation training, mobile medical treatment, and other ways, stratification and stage, early identification, prevention and treatment combination, accurate intervention to comprehensively reduce the occurrence and development of gaming disorder.


Eligibility Criteria:
Inclusion Criteria:

* (1)Clinical diagnosis of severe Gaming Disorder defined in the ICD-11; (2)Normal hearing and vision, or within normal range after correction;

Exclusion Criteria:

* (1) Clinical diagnosis of mental health disorders other than GD defined in the ICD-11 in the past 5 years；(2) Suffering from diseases that affect cognitive function (such as cerebrovascular diseases) ; (3) Schizophrenia, bipolar disorder, depression or other Axis I disorder of DSM-V criteria;(4)any contraindication for tACS intervention.
Lifestyle Therapy for Youth With Type 2 Diabetes

Background: Little is known about the efficacy of intensive lifestyle therapy (i.e. increased physical activity and dietary changes) for the management of glycemia and cardiometabolic risk factors in children and adolescents with type 2 diabetes (T2DM).

Our hypothesis is that education regarding healthy lifestyle changes will significantly reduce blood sugars in youth with T2DM that do not require insulin therapy. Our secondary hypothesis is that the intensive lifestyle therapy will cause quick and sustained reductions in health risk measured by body mass index (BMI), blood pressure, waist circumference, LDL cholesterol, serum triglycerides and apolipoprotein B.

Youth between the ages of 10-20 years living with type 2 diabetes and not currently on insulin therapy will be randomly assigned to either a lifestyle intervention group or a control group. The lifestyle intervention group will meet 2-3 times per week for 16 weeks to take part in healthy living education sessions involving physical activity, healthy cooking, healthy gardening and how to start and sustain a healthy lifestyle change. At the beginning and end of the 16 weeks the investigators will measure the participants' blood sugars, height, weight, cholesterol, triglycerides and liver enzymes. The investigators will also take a picture of their kidney, heart and blood vessels using ultrasound. Those youth assigned to the control group will receive the 16 week intervention following their 16 week control period.

Eligibility Criteria:
Inclusion Criteria:

* youth with a BMI considered overweight according to the International Obesity Task Force
* diagnosed with type 2 diabetes, confirmed with a 2-hour oral glucose tolerance test within two years of enrollment

Exclusion Criteria:

* youth with type 1 diabetes
* use of insulin or other anti-diabetic drugs
* youth with medication-induced diabetes
* youth who have recently been admitted to hospital with ketoacidosis
* youth have experienced weight loss or enrolled in a weightloss program in the last 6 months
* youth with an orthapaedic injury preventing them from exercising
* youth who have a history of alcohol or drug abuse