cyrilzakka/clinical-trials huggingface dataset:
Characteristics and Dynamics of TCR Repertoire in Patients With Hematological Malignancies After Allo-HSCT

Graft-versus-Host Disease (GVHD) and relapse, which is mainly due to lack of Graft-versus-Leukemia (GVL), are the most frequent and severe complications of allogeneic hematopoietic stem cell transplantation (allo-HSCT). T cells expanded from mature T cells in the graft play a dominant role in development of GVHD and GVL early after allo-HSCT. Recent applications of high-throughput sequencing (HTS) to the T cells repertoire open a new avenue for us to look deeply into how these T cells dynamically adjust in the context of the recipient's environment.

The main goal of this research study is to set up a mathematical model based on T cell receptor (TCR) sequencing to enable prediction for the key immunologic outcomes early post-transplantation. This study will deepen the understanding of the molecular mechanisms driving the most deadly post-transplantation complications, and serve as convincing evidence upon which to choose a better donor and a more proper transplantation approach.

This observational trial will perform HTS for TCR β-chain complementarity determining region 3 (CDR3) repertoires of grafts and peripheral blood samples from recipients post-transplantation and analyze the relationship between dynamics of TCR CDR3 repertoires and clinical outcomes early post-transplantation, especially including GVHD and relapse. The investigators want to know how the antigen environment in recipients drives dynamics of mature T cells from grafts in order to use the new discovered rules to better predict and treat the disease process.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with AML, ALL, MDS, undergone myeloablative hematopoietic stem cell transplantation about 1 year ago.
2. Patients who have residual peripheral blood mononuclear cell samples freezed up to now which had been disposed at the time of about 1-month, 2-month after allo-HSCT.
3. Patients whose residual grafts have been freezed up to now.

Exclusion Criteria:

1. Patients whose grafts or residual peripheral blood mononuclear cell samples are failed to be thawed.
2. Patients whose samples are failed with RNA extraction.
3. Patients whose RNA sequencing are failed.
4. Patients who died within 2 months after allo-HSCT.
The Effect of Transcutaneous Electrical Nerve Stimulation on Posterior Neck Pain After Thyroidectomy

The purpose of tihs study is to determine whether transcutaneous electric nerve stimulation (TENS) during thyroidectomy is effective in the reduction of posterior neck pain after thyroidectomy.

Thyroidectomy is performed in supine position with the neck fully extended. After thyroidectomy, 80 percent of patients experience posterior neck pain as well as the incision site pain. The posterior neck pain is thought to be due to hyperextension is continued during an average of 90 minutes of surgery. Non-steroidal anti-inflammatory agents or opioids are administrated to reduce the pain, but the pain still remained.

TENS is simple, non-invasive analgesic technique that is used extensively to reduce acute and chronic pain. TENS has beneficial effect for the reduction of postoperative pain. The conventional way of administering TENS is to use electric characteristics that selectively activate large diameter Aβ fiber mediating touch perception without activating smaller diameter Aδ and C fiber.

In this study, TENS during thyroidectomy in posterior neck pain will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing open total thyroidectomy under general anesthesia
* American Society of Anesthesiology physical status I or II

Exclusion Criteria:

* American Society of Anesthesiology physical status III or IV
* History of headache or neck pain within six months
* Past history of herniated cervical disc, cervical foraminal stenosis, ossification of posterior longitudinal ligament
Tubal Flushing Using Water Soluble Media for Unexplained Infertility

300 women with unexplained infertility will be randomly divided into 2 equal groups: Group 1 will be offered tubal flushing with water soluble media through hysterosalpingography (HSG) and group 2 will receive no intervention

The potential therapeutic effect of diagnostic tubal patency testing has been debated for over 40 years. Tubal flushing might involve water- or oil-soluble media. Current practice usually involves water-soluble media when tubal flushing is performed at laparoscopy. A systematic review showed a significant increase in pregnancy rates with tubal flushing using oil-soluble contrast media when compared with no treatment. Tubal flushing with oil soluble contrast media was associated with an increase in the odds of live birth when compared with tubal flushing with water-soluble media. There were no trials assessing tubal flushing with water-soluble media versus no treatment. The potential consequences of extravasations of oil-soluble contrast media into the pelvic cavity and fallopian tubes may be associated with anaphylaxis and lipogranuloma. It has been reported that Further randomised controlled trials are needed to evaluate the potentially therapeutic effects of tubal flushing with water-soluble media.

All patients attending the subfertility clinic with infertility, normal semen analysis and evidence of ovulation will be invited to participate in the study. The nature of the study and its expected values will be explained and only women who provide written consents will be included in the study.

Three hundred women will be divided into 2 equal groups using computer generated random numbers: Group 1 will have tubal flushing with HSG using water soluble media and group 2 will be the control group receiving no intervention.

Women undergoing HSG will be given 50 mg of diclofenac (Voltaren® Novartis) 1 hour before the procedure. The HSG will be performed in the same room, on the same table and with the same technique to maintain consistency and limit confounding variables.

The HSG procedure will performed in a lithotomy position. A sterile metal speculum was used to visualize the uterine cervix. Antiseptic solution will be used to wash the vagina and cervix. A single-toothed tenaculum will be placed on the anterior lip of the cervix. A metal cannula will be gently inserted into the external cervical os, the cannula and tenaculum will be secured together, and the speculum will be removed. Gentle traction will be placed on the tenaculum, and 15 mL to 20 mL of water-soluble media (Sodium Amidotrizoate; urografin®, Bayer, Germany) will be instilled slowly via the cannula to prevent pain while the necessary images were obtained. After the procedure, the instruments will be removed and the patient will be observed for 30 minutes.

Women will be followed up monthly for up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* infertility for one year
* Normal semen analysis
* Normal ovulation

Exclusion Criteria:

* Allergy to Iodine
* Metformin therapy
* Tubal block
Will Restasis Eye Drops Increase Your Chance of Having a Successful Surgery?

The purpose of this study is to determine whether reducing inflammation of the surface of the eye with topical Restasis after glaucoma surgery will improve surgical outcomes and increase patient comfort.

Continued use of glaucoma drops can alter the outer surface of the eye and result in swelling and irritation, changing the structure of the eye. This structural change has been found to be a significant risk factor for the failure of glaucoma surgery. A comparison of how well patients do after glaucoma surgery depending on whether they use Restasis (the only prescription medication approved by the FDA for treating dry eye) or artificial tears (which can be purchased without a prescription) for 6 months following their surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with uncontrolled glaucoma scheduled for filtering surgery

Exclusion Criteria:

* Under 18 years of age
* Unable to understand informed consent
Effects of Caffeine on Upper Extremity Performance

It was aimed to apply caffeine supplement to elite basketball players and to investigate the effects of this supplement on upper extremity performance, lactic acid level and fatigue. The investigators also aimed to investigate the effects of blood lactate level on performance and fatigue.

The aim of this study is to examine the effects of caffeine supplementation on upper extremity performance, lactic acid and fatigue in elite basketball players and compare them with the placebo group. A total of 50 elite basketball players, 25 each in the caffeine and placebo groups, will participate in the study. Caffeine supplement will be given 1 hour before the measurements (5mg/kg). Muscular endurance before and after reinforcement, scapular muscular endurance test (SKET); arm movement speed, disc touch test (DDT); anaerobic power, medicine ball throwing (STF); lactic acid (LA) level will be evaluated by finger blood measurement and fatigue visual analog scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Elite basketball players aged 19-44
* Individuals with caffeine consumption below 2 mg per kg per day

Exclusion Criteria:

* Individuals with systemic disease affecting the musculoskeletal system
* Individuals using supplements containing caffeine
* Individuals with any diagnosed neurological or orthopedic disease
A Mobile Application for Female Athletes with Pelvic Floor Dysfunctions (ACTITUD2.0)

Pelvic floor dysfunctions (PFD) are especially prevalent among females. As conservative management, strengthening pelvic floor (PF) musculature under health supervision, regard an important research line. However, embarrassment of female athletes limits healthcare demands. New technologies could facilitate an autonomous but supervised tele-rehabilitation programs.

This study will evaluate the effects of a 12-weeks program with exercises focused on PF awareness and strengthening by using a mobile application supervised by physiotherapists, with or without intracavitary biofeedback, on the PF anatomical and functional characteristics, symptomatology and sports performance of female athletes with PFD.

To this end, 105 female athletes with self-reported PFD who train and compete in sport in Spain will be recruited and randomly distributed in three groups of the experimental study. During 12 weeks, all participants will use the mobile application (named ACTITUD): the control group (CG) will have access to information about PF and direct communication with healthcare team; experimental group 1 (EG1) will have access to the same information and communication, and will perform a the exercise program for PF; the experimental group 2 (EG2) will be similar to EG1, but they will use an intravaginal biofeedback device during exercises to receive information about their intra-vaginal pressure.

Before and after these 12 weeks, anatomical and functional PF characteristics, PF symptoms and sports performance of all participants will be evaluated. As additional outcome, the compliance of the athletes from experimental groups to complete the training program will be registered (in %).

Female athletes from EG1 and EG2 will complete the exercise program for PF three times per week, during 12 weeks. Each session will last about 20 minutes and exercises will be modified every two weeks to meet the principle of training progression and avoid athletes become bored.

Eligibility Criteria:
Inclusion Criteria:

* To train and compete in any sport.
* To have a self-reported pelvic floor disorder (urinary incontinence, anorectal incontinence, sexual dysfunction or chronic pelvic pain).

Exclusion Criteria:

* To have recurrent infections of urinary tract during the last three months.
* To be receiving physiotherapy treatment due to any pelvic floor disorder at the moment of the start of the study.
* To have been pregnant during the year prior to the start of the study.
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist

This is an exploratory, double blinded cross-over study of the D1 antagonist ecopipam treat patients currently having dopamine agonist induced augmentation in restless legs syndrome. Each arm is 6 weeks composed of an unforced titration up to 100mg/day separated by a 2-week wash-out period. Efficacy points will include the IRLS, augmentation scales, sleep scales, clinical impressions and fatigue/mood scales.

This is a double-blind, exploratory proof of concept, cross-over trial of the D1 antagonist ecopipam for subjects with augmented Restless legs syndrome (RLS). Investigators will recruit 10 subjects taking dopamine agonists for RLS who are currently experiencing augmentation. The goal is to have 8 completers. There is no power analysis as this is an exploratory study and there is no previous data on treatment of augmentation. "Meaningful improvement" is not even established. A safety analysis will be done after 5 subjects have been enrolled. Duration of study and is based mostly on contracted drug availability for this pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Provide consent to participate in the study
* Individuals of either sex, 21-80 years of age
* Clinically defined Restless Leg Syndrome, and problematic augmentation currently on monotherapy with dopaminergic treatment.

Exclusion Criteria:

* Current use of Opioid medications
* Clinical relevant depression or other medical problems that in the opinion of the investigator would not allow for safe completion of the protocol.
* Suicidal ideation
* History of epilepsy
* Current MAO inhibitors
The Effect of Hyoscine Butyl Bromide on the First Stage of Labor in Term Pregnancies

To determine whether hyoscine butyl bromide is effective in shortening the first stage of labor, with no increase in maternal or neonatal complications.

Hyoscine butyl bromide has been used to shorten the duration of labor in several hospitals here in Jamaica, as it has elsewhere in the world. Thus, it represents a new addition to the armamentarium of active management. The mechanism by which it acts in the context of labor has not yet been elucidated, and the evidence for its efficacy was previously largely anecdotal. The specific objectives of this project are to assess whether hyoscine butyl bromide (in the form of Buscopan®) is effective in hastening cervical effacement and dilatation, thus shortening the duration of the first stage of labor. We also intend to determine whether the use of hyoscine butyl bromide in the first stage of labor has any associated increase in complications, such as an increase in blood loss or rate of Caesarean deliveries, or a decrease in neonatal APGAR scores.

The study was designed as a double blind, randomized, controlled, clinical trial comparing two groups of patients matched for age and parity. One group of patients received the 20 mg(1 ml)of hyoscine butyl bromide, while the other (control) group received 1 ml of normal saline (placebo).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Term pregnancy
* In spontaneous, established labour

Exclusion Criteria:

* Contraindication to vaginal delivery
* Any chronic medical or pregnancy induced illness
Hypnotic Medications and Memory: Effect of Drug Exposure During the Night

The purpose of this study is to determine the effect of two hypnotic medications, zolpidem extended release and zaleplon, on memory. It is expected that a hypnotic with shorter drug duration will allow greater memory consolidation than a hypnotic with longer drug duration.

A growing body of evidence has demonstrated that sleep promotes memory consolidation in healthy individuals. However, little research has been conducted regarding the effect of hypnotics on sleep-dependent memory. One study found that zopiclone (7.5 mg), but not brotizolam (0.25 mg), impaired sleep-dependent memory consolidation in normal sleepers. Another study reported significant impairment of sleep-dependent memory on a motor task with triazolam (0.375 mg), but not with zolpidem immediate release (10 mg). These studies provide some evidence that sedative-hypnotic drugs may impair sleep-dependent memory consolidation, but further investigation is clearly needed in this area. Because hypnotics are commonly prescribed for insomnia, it is important to determine if there is a significant risk of impairment in sleep-dependent memory consolidation associated with these medications. Further, investigation of alternative doses and drug regimens upon memory consolidation appears warranted.

The purpose of the current study is to determine the effect of two hypnotic medications on sleep-dependent memory consolidation in normal sleepers. Zolpidem extended release, which will be active for most of the sleep period when administered at bedtime, will be compared to zaleplon, which will be active for half of the sleep period when administered in the middle of the night. This comparison allows us to address the question of whether a few hours of drug-free sleep results in better memory consolidation than sleep with drug throughout the night.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 years of age
* no sleep complaints or problems
* good sleep quality per questionnaire
* sufficient time in bed each night

Exclusion Criteria:

* any clinically significant unstable medical condition
* recent psychiatric disorder
* prior diagnosis or symptoms of a sleep disorder
* recent history of substance abuse
* recent use of prescription hypnotic medication or over-the-counter sleep aid
* recent use of psychotropic medication
* history of adverse reaction to benzodiazepines
* body mass index \> 36
* currently pregnant or nursing
* currently working rotating or night shift
* consumption of \> 700 mg per day of xanthine-containing food or beverages
* consumption of \> 14 units of alcohol per week
* smoke \> 1 pack of cigarettes per day, use of chewing tobacco more than 3 times per day, or unable to refrain from smoking or chewing without distress or discomfort while in the sleep laboratory
Journey of Life Psychosocial Support Program

The proposed study evaluates the impact and implementation of the Journey of Life intervention among crisis-affected caregivers living in Western Uganda. In this quasi experimental waitlist control design, participants will be assigned to treatment or waitlist control group based on their geographic location. The intervention will be delivered in X sessions weekly. Assessments will be conducted at baseline and following the intervention period. Assessments will include mental health, functioning, social support, child protection behaviors, parenting attitudes, and experiences of intimate partner violence. The study also aims to examine implementation of the Journey of Life intervention through qualitative assessments of feasibility, acceptability, adaptation, reach, and adoption.

Aligned with the USAID HEARD (Health Evaluation and Applied Research Development) purpose to leverage global partnerships to generate, synthesize, and use evidence to improve program implementation in low and middle-income countries, the proposed study will examine the impact and implementation of the Journey of Life (JoL) intervention in a humanitarian setting. The JoL intervention aims to provide psychosocial support to adults and galvanize caregivers to develop action plans for child protection in their communities. The proposed research will involve an analysis of effect sizes for mental health, functioning, social support, child protection behaviors, parenting attitudes and behaviors, and experiences of intimate partner violence. The research also aims to interrogate implementation strategies that are useful within humanitarian contexts through qualitative key informant interviews and focus group discussions. Assessments include baseline and follow up data collection to measure effect sizes and assess implementation strategy components. The study aims are to: (1) assess the impact of JoL on child protection indicators, (2) examine the effects of JoL on behavioral health functioning (i.e. mental health, social support, and functioning)

Eligibility Criteria:
Inclusion Criteria:

* Refugee living in Kiryandongo settlement
* Over the age of 18
* Caregiver for a child under age 18

Exclusion Criteria:

* Anyone aged 17 and under, unless written consent from the caregiver and assent from the participant is provided
* Anyone unable to provide consent to participate
A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age with a minimum body weight of ≥42 kg at Visit 1 (Screening)
* Subject has a documented definite or probable diagnosis of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) according to the European Federation of Neurological Societies (EFNS)/ Peripheral Nerve Society (PNS) criteria 2010
* Subject has an immunoglobulin-dependency confirmed by clinical examination during therapy or upon interruption or reduction of therapy within 18 months prior to Screening and documented in medical history
* Subject is on a stable dosage (not more than ±20% deviation) for subcutaneous immunoglobulin (SCIg) or intravenous immunoglobulin (IVIg) and a fixed interval for at least 4 months of either treatment
* Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their final dose of investigational medicinal product (IMP)
* Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the final administration of IMP

Exclusion Criteria:

* Previously received treatment in this study or subject has previously been exposed to rozanolixizumab
* Current diagnosis or has a history of Type 1 or Type 2 diabetes mellitus and/or hemoglobin A1c level \>6.0 %
* Known immunoglobulin M (IgM)-mediated neuropathy
* Clinical or known evidence of associated systemic diseases that might cause neuropathy or treatment with agents that might lead to neuropathy
* History of clinically relevant ongoing chronic infections
* Family history of primary immunodeficiency
* Received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
* Received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline
* Prior treatment with rituximab, ofatumumab, or ocrelizumab in the 6 months prior to the Baseline Visit or subject has had prior treatment with rituximab, ofatumumab, or ocrelizumab in the 12 months prior to Baseline and B cells are not within the normal range
* Female subject who is pregnant or lactating