cyrilzakka/clinical-trials huggingface dataset:
A Non-drug Study Profiling Cutaneous Lupus

The purpose of this study is to characterize the clinical and molecular profiles of patients with cutaneous lupus.

This is a Phase 0, multiple-center observational study of biomarkers and clinical parameters in patients with lupus, including discoid lupus erythematosus (DLE), subacute cutaneous LE (SCLE) and active systemic lupus erythematosus (SLE). There is no study-related therapeutic intervention and this protocol will not restrict or introduce any medical interventions including medications. Study participants will undergo procedures that include collection of urine, blood samples, and skin biopsy. At least 30 participants (≥10 DLE, ≥10 SCLE, and ≥10 SLE) will be enrolled in this study. All participants will continue to be managed by their personal physicians per their standard of care. The data obtained in this study will help in the evaluation of new therapeutics for lupus and may facilitate lupus drug discovery. A blood sample for genomic analysis will be collected for research purposes from patients who provide consent and where local regulations permit. There will be a single sample collection time point for each patient. The safety assessments will include laboratory measurements (serum chemistry and hematology), monitoring of adverse events (AEs) related to study procedures, and physical examination.

Eligibility Criteria:
Inclusion Criteria:

* have active DLE or active SCLE confirmed by histological analysis
* have a confirmed diagnosis of SLE with SLE Disease Activity Index (SLEDAI) of \>6 and current or historical positive ANA or anti-dsDNA
* have an active skin lesion that can be biopsied
* if using hydroxychloroquine or chloroquine, must be on stable doses for at least 2 months prior to screening.

Exclusion Criteria:

* have an active skin disease other than CLE

  * have any known malignancy within the previous 5 years (with the exception of a non-melanoma skin cancer that has been treated with no evidence of recurrence)
  * have used a topical corticosteroid on active lesion
  * have donated blood (volume \>=500 mL) within 56 days prior to screening
  * has been treated with drugs that are associated with CLE induction within 2 months prior to the screening
  * have been treated with \>10 mg/day prednisone therapy or equivalent in the last 4 weeks prior to screening.
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)

The purpose of this study is to determine the safety and tolerability of the anti-TSG101 human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy volunteers.

Primary -

- To compare the safety profile of a single intravenous administration of FGI-101-1A6 as compared with Placebo

Secondary

* To evaluate the pharmacokinetics (PK) of a singel intravenous administration of FGI-101-1A6
* To evaluate the immunogenicity of FGI-101-1A6

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers ages 18-45
* Normal laboratory (blood tests) results

Exclusion Criteria:

* Prior immunization with live-attenuated vaccines
Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy

Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in laparoscopic right colectomy reduces post-operative bowel canalisation time and length of stay in comparison with extracorporeal mechanical anastomosis.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or more
* Benign o neoplastic disease of right colon
* Elective laparoscopic surgery

Exclusion Criteria:

* Emergency surgery
* Adhesion or infiltration of near organs
* Severe heart disease ( New York Heart Association class \> 3 )
* Severe respiratory disease ( arterial PO2 \< 70 torr )
* Severe Liver disease (Child-Pugh class C)
* Ongoing infections
* Number of plasmatic neutrophil \< a 2.0 x 10 9/L
* Other contraindications to laparoscopy
The Objectives of This Study Are Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years

Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years

All subjects will be followed up for 21 days post-randomization. The subjects will further be assessed at 2 days, 7 days, 21 days following the booster vaccination. Blood samples will be collected for reactogenicity and safety and immunogenicity assessments before injection and 21 days after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the volunteers to participate in the clinical study;
* Healthy volunteers (men and women) aged 18-60 years;
* Volunteers with a titer of antibodies to A(H1N1), A(H3N2) and B influenza viruses less than 1:40 in a HI test
* Volunteers able to fulfill requirements of the protocol (i.e. fill out the patient's diary, come to follow-up visits);
* Female participants were obliged to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception for women of reproductive age)

Exclusion Criteria:

* Allergic reactions to chicken protein or any previous influenza vaccination;
* Leukemia, cancer or a positive reaction to HIV infection, hepatitis B and C, syphilis in the medical history;
* Volunteers who received immunoglobulin or blood products within the last three months before the study;
* Guillain-Barre syndrome (acute polyneuropathy) in the medical history;
* Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the study;
* Any confirmed or suspected immunosuppressive or immunodeficiency condition;
* Respiratory, cardiovascular failure, impaired liver or kidney function found during a physical examination or laboratory tests at Visit 1;
* Severe birth defects or serious chronic diseases, including any clinically significant chronic diseases of lungs, kidneys, cardiovascular, nervous system, psychiatric diseases or metabolic disorders, confirmed by medical history or objective examination;
* Volunteers who are (or were) patients of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary
* acute infectious and/or non-infectious diseases at the time of inclusion in the study;
* Exacerbation of chronic diseases;
* Alcohol abuse and/or use of drugs in the past history;
* Pregnancy and lactation;
* Participation in another clinical study within the last 3 months
Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem

The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the RM Pressfit vitamys cup. The data will be used for an ongoing evaluation of the product safety and performance.

Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the RM Pressfit vitamys cup. In total 675 participants in 9 clinics are included in this international multicenter study.

The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery.

The following parameters will be collected during the regular clinical and radiological follow-up: Harris Hip Score, radiographic evaluation and detection of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form (signed by participant and investigator)
* Primary implantation
* Age at inclusion: Between 18 and 95 years old
* Willing to participate in the follow-up

Exclusion Criteria:

* Missing Informed consent form
* Known or suspected non-compliance (e.g. drug or alcohol abuse)
* Enrollment of the investigator, his/her family, employees and other dependent persons
* Patient younger than 18 years old
* Revision surgery
* Presence of sepsis or malignant tumors
* Pregnancy
Effect of Electroconvulsive Therapy on Retinal Nerve Fiber Layer Thickness in Depression

The aim of this study is to investigate the changes in the retinal nerve fiber layer thickness of the patients with depression who received electroconvulsive therapy by means of optical coherence tomography.

Major depression (MD) is a mood disorder that is common in the society, has negative effects on emotion, thought and behavior, and leads to significant impairments in functionality. Electroconvulsive therapy (ECT) is a highly effective and reliable biological treatment method used in psychiatric diseases for a long time. The most common use in psychiatry is depression. Studies have shown that ECT causes a broadly distributed increase in brain gray matter volume (especially the temporal lobe) in MD patients. Optical coherence tomography (OCT) is a non-invasive medical imaging method that displays biological tissue layers by taking high resolution tomographic sections. Alterations in the thickness of the retinal nerve fiber layer (RNFL), which is a layer of the ganglion cell complex in the retina of the eye and consists of ganglion cell axons, occur due to axonal damage in the retinal nerve tissue. Since RNFL is in a similar form with the brain gray matter tissue, recently, neurological and psychiatric studies have been conducted to provide data regarding the neurodegeneration occurring in the brain tissue. In the study, it is aimed to assess the possible cortical volume changes of patients by measuring changes in the retinal layers due to ECT in patients with depression. In other words, considering that ECT causes an increase in brain volume, it is to observe whether this increase is reflected in the retinal nerve fiber layer thickness.

Eligibility Criteria:
Inclusion Criteria:

* Subject diagnosed as unipolar depression
* Subject with depression to be treated with electroconvulsive therapy
* Subject with depression having a Standardized Mini Mental Test score of \>23

Exclusion Criteria:

* Any comorbid psychiatric condition (including alcohol / substance use)
* Having any major neurological (i.e.: cerebrovascular disease, multiple sclerosis, etc.) disease
* Having any major medical (i.e.: diabetes mellitus, myocardial infarction, etc.) disease
* History of or having any ocular trauma, disease or surgery, any retinal disease, refraction defect
* To be treated with electroconvulsive therapy in the last 6 months
Identification of Biomarkers in Spinocerebellar Ataxia 3

The purpose of this study is to examine the differences in cerebral spinal fluid (CSF) and blood of patients with spinocerebellar ataxias and healthy volunteers. The goal of this project is to identify new biomarkers that are useful for characterizing spinocerebellar ataxias and identify targets for treatment or prevention of this condition.

Participants will undergo a SARA exam, a lumbar puncture and a blood draw. A lumbar puncture is a procedure in which a small amount of the spinal fluid that surrounds the brain and spinal cord is removed by inserting a needle in the lower back. Participants will be asked not to eat or drink anything (water is acceptable) for at least 6 hours before the lumbar puncture visit. For this procedure, participants will be positioned lying on their side and curled up in a ball, or sitting up and bent forward, whichever is easier. Cushions will be used to enhance comfort. The lower back region will be cleaned and disinfected with an antiseptic iodine solution. The doctor will inject local anesthetic (lidocaine, 1%) into the skin of the lower back. This may produce a transient, mild burning sensation. A very small needle will be introduced into the skin and moved into fluid-filled space around the spinal nerves coming from the spinal cord. This may produce a pressure sensation. Approximately 2 tablespoons approximately 30 ml) of fluid will be collected. The needle will be removed and a band-aid applied over the needle insertion site. Participants will be asked to remain stationary, lying on flat for about ½ hour on a bed in the research clinic. Participants will be given something to eat and drink before leaving. Strenuous physical activity should be avoided for the next 24 hours. This includes lifting, bending, doing housework and gardening, or doing exercise such as jogging or bicycle riding. The SARA (Scale for the Assessment and Rating of Ataxia) exam is a clinical scale that assesses a range of different impairments in cerebellar ataxia. The scale is made up of 8 items related to gait, stance, sitting, speech, fingerchase test, nose-finger test, fast alternating movements and heel-shin test, and takes approximately 15 minutes to complete.

The study also involves a single collection of about 3.5 tablespoons (approximately 50 ml) of blood. This blood draw may take place during a regularly scheduled visit to the neurology clinic or at the research appointment.

Eligibility Criteria:
Inclusion Criteria:

•Confirmed Genetic Testing of SCA3 or Healthy Volunteers

Exclusion Criteria:

* People with:

  * unstable thyroid
  * unstable intestinal/stomach issues
  * unstable heart issues
  * unstable liver issues
  * unstable kidney issues
  * unstable lung issues
  * unstable hormone issues
  * unstable mental disorders at screening
  * a tumor or evidence of having a tumor
  * a chronic infection or any severe acute infection within 3 months prior to screening
* People who:

  * Take anti-coagulants and NSAIDs
  * Have started any investigational medications in the last month
* Women who are pregnant or breast feeding
Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment

The objective of this work was to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the balance, functionality and cognition of patients with Parkinson´s disease. It was a prospective, single blinded, randomized clinical trial performed at Brazil Parkinson Association and Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. 32 patients with Parkinson´s disease on stages 1 and 2,5 of Hoehn e Yahr participated of this work. Patients were randomized in control and experimental group, 16 each one.

The study was finished at december 2011.

The objective of this work was to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the balance, functionality and cognition of patients with Parkinson´s disease. It was a prospective, single blinded, randomized clinical trial performed at Brazil Parkinson Association and Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. 32 patients with Parkinson´s disease on stages 1 and 2,5 of Hoehn e Yahr participated of this work. Patients were randomized in control and experimental group, 16 each one. Both groups performed 14 training sessions, twice a week, for seven weeks. Each session was composed of a 30 minute-global-exercise series including stretching, muscle strengthen and axial mobility exercises. After this, both groups performed more 30 minutes of balance training: the control group performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group performed the balance training with 10 Wii Fit games which stimulated motor and cognitive functions. The main outcome measures were: (1) Unified Parkinson´s Disease Rating Scale (UPDRS); (2) Berg Balance Scale (BBS); (3) Unipedal Stance Test (UST) and (4) Montreal Cognitive Assessment (MoCA). The statistical analysis was done by repeated measures ANOVA in order to assess the possible differences among the analyzed variables. Both groups showed improvement in the section II of UPDRS, BBS, UST and MoCA. Patients with Parkinson´s disease showed balance and cognitive improvement with positive repercussion on daily living activities after 14 sessions of balance training without additional advantages to the virtual training.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson´s disease
* both gender
* on stages 1 and 2,5 of Hoehn e Yahr

Exclusion Criteria:

* depression
* cognitive impairment
* deficits of visual acuity
* Score on Berg Balance Scale under 46
Postpartum Immediate Contraception in Cesarean Deliveries-Comparison of Two Intrauterine Systems

To compare two intrauterine systems in order to avoid complications originating from short pregnancy interval and undesired pregnancies in the early postpartum period.

The patients admitting to Zeynep Kamil Research and Training Hospital for caesarean delivery will be included in the study. There will be two computer based randomized groups. The investigators expect that both groups will have 100 cases. First group will be treated with conventional intrauterine devices (Cu T380 A) while the second group will be treated with frameless intrauterine devices (GyneFix). The participants will be informed about postpartum unplanned pregnancies and the complications of short pregnancy interval. Participants will also be informed about possible complications of having an intrauterine device and that there may be a possibility of failure.The participants who choose to participate in the study will be divided into two groups by computer based randomization and one of the systems will be applied. After the participants read and sign the informed consent form, the intrauterine device will be applied postplacental up to 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* The patients who read and sign the informed consent form.

Exclusion Criteria:

* The patient who has more than 6 cm dilatation, prolonged premature rupture of the membranes (more than 12 hours), chorioamnionitis, and kongenital or acquired haemorragic diathesis will be excluded from the study.
The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid

The aim of this study was to evaluate the efficacy and safety of Mesenchymal Stem Cells (MSCs) from adipose anticular injection in comparison with hyaluronic acid anticular injection in the treatment of human knee osteoarthritis(OA).

This is a single-centre, quadruple blined, randomized controlled clinical trials with a total of 14 knee osteoarthrits patients as participants, who will be randomly assigned into experiment group or compare group.Participants in experiment group will receive the treatment of MSCs from adipose anticular injection, while participants in compare group will receive hyaluronic acid. Unexplained local and systemic symptoms as well as visual analog scale pain score, WesternOntario McMasterUniversities (WOMAC) Osteoarthritis Index scorewill be assessed at baseline and 2 years after the injection.

Eligibility Criteria:
Inclusion Criteria:

* K / L score of 2-3;
* chronic knee pain;
* no local or systemic infection;
* without obvious contraindication of the joint puncture from hematology and biochemical tests;
* informed consent.

Exclusion Criteria:

* older than 75 years old or less than 18 years old, or without full capacity for civil conduct;
* HIV, hepatitis virus or syphilis virus infection or their serology is positive;
* BMI index is greater than 30;
* congenital or acquired knee deformity;
* pregnant or lactating women;
* tumor patients;
* immunodeficiency patients;
* intra-articular drug injection history within 3 months;
* participating in other clinical trials;
* other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.
Different Strategies in Frozen IVF/ICSI Cycles

In the absence of robust contemporary data, investigators decided to perform a multicenter cohort study of various IVF centers, to compare the different modalities used for pregnancy rates following frozen-thawed embryo transfer (FET) treatment cycles in normoovulatory patients undergoing IVF/ICSI.

In general, the type of FET protocol for each patient is selected by the attending physicians at their own discretion. In all centers, patients with ovulatory cycles are typically prescribed an NC-FET or mNC-FET, whereas patients with oligomenorrhoea or amenorrhoea are prescribed an artificial cycle to prepare the endometrium for FET.

Ovarian stimulation protocol

1. The antagonist protocol
2. The long 21 /2 agonist protocol Laboratory technique

a. IVF or b. ICSI Embryo freezing using only vitrification will be performed in days 3 or 5/6. Embryo transfer will be conducted at days 3 or 5/6. The maximum number of embryos transferred will be two, as in accordance to the Hellenic legislation.

The following modalities will be analyzed, patients with:

1. Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG without luteal support (Group 1)
2. Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG with luteal support (progesterone) (Group 2)
3. Hormone Replacement cycle (cyclacur) plus GnRHa suppression with luteal support (progesterone) (Group 3)
4. Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone) (Group 4)

Of note, the conversion between different supplementation methods may be testimated as follows: 0.75 mg of micronised estradiol (oral administration) = 1.25 g of estradiol gel (transdermal administration) = 1 mg of estradiol valerate (oral or vaginal adminstration).

Eligibility Criteria:
Inclusion Criteria:

age 25-39 years, BMI ≤ 35 and ≥ 19, normo-ovulatory patients and basal FSH ≤11 mIU/mL. Definition of expected normal ovarian response will be based primarily on antral follicle count (AFC) between 6-14.

Exclusion Criteria:

history of more than three previous unsuccessful IVF/ICSI cycles, FSH \> 12 mIU/mL, BMI \>35 or \<19, poor ovarian response according to the 2011 Bologna criteria, PCOS patients according to the Rotterdam criteria, history of untreated autoimmune, endocrine or metabolic disorders, history of pathology affecting the endometrial cavity and/or receptivity and clinical and/or laboratory markers of hereditary or acquired thrombophilia that complied to the standard protocols of each Unit and patients without embryo after thawing.
A Randomized Controlled Study of Uterine Incision Diverticulum Repair vs. no Repair During Second/Third Cesarean Section

The goal of this study is to assess the efficacy and safety of uterine incision diverticulum repair during repeat cesarean section.The main questions it aims to answer are:

* Can this surgical method improve the symptom of menorrhagia？
* Is this procedure safe？ Researchers will compare experimental group(Cesarean section + diverticulum repair group) to control group(Conventional cesarean section group) to see if this surgical method works to treat or improve menorrhagia.

Participants will:

* randomly assigned 1:1 to the experimental group（repairing uterine diverticula during cesarean section) and the control group （Routine cesarean section without repairing the uterine incision diverticulum）
* visit the hospital 42 days after surgery
* followed up by telephone 6-12 months after surgery


Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥18 years, gestational age ≥37 weeks, singleton pregnancy, previous lower segment cesarean section, second or third cesarean section, and diagnosed with uterine incision diverticulum by imaging before or during early pregnancy.

Exclusion Criteria:

* Preoperative indications of placenta accreta or previa, interdelivery interval less than 18 months from the last cesarean section, history of other uterine surgeries, and severe obstetric or medical complications requiring emergency care.