cyrilzakka/clinical-trials huggingface dataset:
Use of Low-dose Zolpidem in Parkinson's Disease

This study will evaluate the motor and cognitive benefits of low-dose zolpidem in Parkinson's.

Zolpidem is a hypnotic drug which at sub-sedative doses has been shown to improve both motor and cognitive deficits in stroke, dementia and Parkinson's. This has led to the hypothesis that low-dose zolpidem will be effective in early-stage Parkinson's, delaying the need for dopamine-replacement interventions, as an adjunct therapy, and in late-stage Parkinson's where current interventions are ineffective for motor and cognitive decline. At present, the symptoms of late-stage Parkinson's are the most debilitating and the least well-controlled. Here, the investigators propose a placebo controlled double-blinded proof-of-concept study in order to determine the benefits of taking low-dose zolpidem in late-stage Parkinson's. The study will take place over 12 months. 28 participants, diagnosed with Parkinson's for at least 5 years will be recruited; 14 participants will take zolpidem (5 mg) and 14 placebo, each morning for 4 days. In the clinic (day 1) clinical assessments will include the motor III of the Unified Parkinson's Disease Rating Scale (UPDRS) and cognitive verbal fluency tasks which will be conducted at baseline and 1 hour following drug administration. Each participant will then be issued with a smartphone with application to objectively test their motor performance 4 times a day, over the next six days (3 days on drug, 3 days off drug). This study will provide the necessary data on drug efficacy in order to design a phase II clinical trial for the use of low-dose zolpidem in late-stage Parkinson's.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of idiopathic Parkinson's and Hoehn and Yahr score of 2.5 or more; Willing to participate and refrain from driving whist taking zolpidem/placebo; Within age range 40 to 80 years.

Exclusion Criteria:

Any contraindications as stated in Summary of Product Characteristics (SmPC) for zolpidem:- Hypersensitivity to zolpidem tartrate; Obstructive sleep apnoea; Myasthenia gravis; Severe hepatic insufficiency; Acute and/or severe respiratory depression; Psychotic illness.

and in addition: - Unable or unwilling to give informed consent ; Current therapy with central nervous system (CNS) depressants; Current therapy with Cytochrome P450 (CPY450) inhibitors or inducers (specifically CYP3A4); Pregnancy and breast feeding women; History of alcohol or substance abuse; Employed in a role that involves driving or operating heavy machinery; Participation in another interventional clinical trial.
Eltrombopag Taste Testing in Healthy Adult Volunteers

Based on a need for a pediatric formulation of eltrombopag for the treatment of pediatric thrombocytopenia, this study will help determine the best tasting pediatric formulation of eltrombopag. Healthy adult volunteers who are able to taste bitterness and who do not have a high sensitivity to bitterness will be enrolled. The subjects will evaluate different formulations and rate them based on the bitterness and effectiveness of sweetners. The outcome of this study will help support a decision for a new pediatric formulation of eltrombopag.


Eligibility Criteria:
Inclusion Criteria:

* healthy adult based on a medical evaluation by a responsible physician
* male or female adult between 18 and 55 years old
* female subjects who are not pregnant or lactating
* females who are unable to have children must have documented medical verification
* females who are able to have children must have a negative pregnancy test
* capable of giving written informed consent

Exclusion criteria:

* subjects who are unable to taste bitterness or are extrememly sensitive to bitterness
* participated in a clinical trial within 30 days
* exposure to more than four new medicines within 12 months prior to the first day of dosing
* history of sensitivity to any of the study medications
Empathy and Emotional Regulation: A Multi-National Cross-Sectional Study

Significant levels of psychological disorders and psychological distress among higher education students have been reported worldwide (Galdino et al., 2020), given that during these years there is a peak in prevalence of many mental disorders, particularly major depressive disorder (18.5% to 21.2%), generalized anxiety disorder (18.6% to 16.7%) and drug use disorder (45.9% to 59.8%). (Auerbach et al., 2018). Additionally, compared to other major students, medical school and nursing students experienced higher levels of burnout due to the complex curriculum and pressure for professional performance (Ling et al., 2014). Altogether, this evidence show that nursing students frequently experience psychological and emotional problems such as academic exhaustion, stress, depression, and anxiety during their four years of completing their degree (Hwang \& Kim, 2022).

To the best of our knowledge, this study is the first of its kind that addresses the issue of burnout and its relation to empathy and emotional regulation among nursing students at the middle east. Analyzing burnout syndrome among undergraduate nursing students may provide support for managers to implement prevention and management strategies in relation to the syndrome, in order to ensure health and well-being during the professional training process, as well as providing training for nurses engaged and prepared to provide quality care. Thus, this study aims to investigate the burnout syndrome among nursing students and its relation to empathy and emotional regulation.


Eligibility Criteria:
Inclusion Criteria:

* Undergraduate nursing students from the five full-time levels

Exclusion Criteria:

-
Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.


Eligibility Criteria:
Inclusion Criteria:

* A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject prior to enrolment.
* Subject must have a negative urine pregnancy test.
* Healthy subject before entering the study entry as established by medical history and physical examination.
* Subject must be of non-childbearing potential.

Exclusion Criteria:

* pregnant or breastfeeding subject.
* previous vaccination against human papillomavirus (HPV).
* Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality.
* History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.
Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents.

The goal of this observational study is to learn about the role of the human gut microbiome in antidepressant treatment response in adolescents with Major Depressive Disorder (MDD). Specifically, the study aims to collect microbiota samples of adolescents treated with fluoxetine, over the span of 8-weeks, to:

* determine the influence of the microbiome on the efficacy of fluoxetine to treat adolescent depression.
* test whether the gut microbiome from different timepoints can predict ultimate success of fluoxetine
* investigate the interaction of gut microbiome composition and pharmacogenetic metabolizer status on steady-state plasma concentrations of fluoxetine.

Depression symptom severity will be evaluated upon enrollment and 6-weeks into antidepressant treatment.

For this project the investigators are interested in changes in the gut microbiome associated with adolescent depression and the influence of the microbiome on the efficacy of fluoxetine to treat adolescent depression. It is hypothesized that the composition of the human gut microbiome alters the response to fluoxetine of adolescents with depression. This study aims to collect gut microbiota of adolescents being treated with antidepressants at several timepoints to (1) determine the efficacy of fluoxetine to treat depression, (2) test whether the gut microbiome from different timepoints can predict ultimate success of fluoxetine, and (3) investigate the interaction of gut microbiome composition and pharmacogenetic metabolizer status on steady-state plasma concentrations of fluoxetine. Adolescent patients with clinically significant depressive symptoms who are prescribed fluoxetine, from Rady Children's Hospital San Diego (RCHSD) Inpatient Child and Adolescent Psychiatry Services (CAPS), will be recruited for this study. Up to twelve stool samples are planned to be collected, including prior to start of antidepressant treatment for a baseline measure of gut microbiome composition, daily samples over during the first week of fluoxetine treatment, and then biweekly collections until the end of the 8-week study duration.

Eligibility Criteria:
Inclusion Criteria:

* Subjects from all ethnic backgrounds will be eligible to participate.
* Having clinically significant depressive symptoms based on a score \>40 on the Children's Depression Rating Scale-Revised
* Prescribed more than 5mg of Fluoxetine (Prozac)
* Has an identifiable legal guardian.

Exclusion Criteria:

* Has been taking a standing psychotropic medication in the past 6 months
* Has been taking antibiotics or metformin during the past 6 months (known strong effects on gut microbiome)
* Admitted to RCHSD CAPS post-overdose (potential strong effects on gut microbiome)
* Currently using nicotine-containing substances (known strong effects on gut microbiome)
The Use of DPP-4 Inhibitors in Short Bowel Syndrome

The inhibition of Dipeptidyl peptidase-4 should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine.

The only effective (to some extend drug) in short bowel syndrome is Glucacone-like peptide 4. Its price is, however, to high to really change the treatment strategy for intestinal failure. The Dipeptidyl peptidase-4 inhibitor, which a drug which is commonly used in the treatment of diabetes mellitus type II, should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving home parenteral nutrition (HPN) because of short bowel syndrome for at least 12 months
* stable metabolic status
* benign disease

Exclusion Criteria:

* HPN \< 12 months
* metabolically unstable
* cancer as the reason for intestinal failure
Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML

This project is a prospective, multicenter, randomized controlled clinical study. The subjects were refractory / relapsed AML patients aged ≤ 60 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The classical Bu / Cy scheme or MCBC scheme was used for pretreatment. The primary endpoint of the study was the 3-year recurrence-free survival rate after allogeneic hematopoietic stem cell transplantation, and the secondary endpoints were 3-year overall survival rate, recurrence rate, treatment-related mortality, and pretreatment-related toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Refractory / relapsed AML.
* Patients with a HLA matched related or unrelated donor (9\~10/10) or haplo-identical related donor, plan to receive HSCT.
* Age ≤ 60 years old, men and women are not limited.
* The Eastern Oncology Collaborative Group Physical Status Assessment ( ECOG-PS ) was 0-2 points.
* Informed consent must be signed before the start of the study procedure. Informed consent must be signed by the patient or his or her immediate family members who are 18 years of age or older ; informed consent was signed by the legal guardian for children and adolescent patients under 18 years old. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.

Exclusion Criteria:

* Have a history of cancer and have received any treatment for this tumor in the past 3 years. But remove superficial bladder cancer, skin basal cells or squamous cell carcinoma, cervical epithelium. Intraepithelial neoplasia ( CIN ) or prostatic intraepithelial neoplasia ( PIN ).
* MPAL.
* It is known that the serological reaction of HIV or active hepatitis C virus is positive.
* The inability to cooperate with the requirements of research, treatment and monitoring due to mental illness or other conditions.
* Pregnant patients or patients who could not take appropriate contraceptive measures during treatment.
* Previously received hematopoietic stem cell transplantation.
* Active heart disease, defined as one or more of the following :

  1. ) Uncontrolled or symptomatic angina history.
  2. ) Myocardial infarction less than 6 months away from the study.
  3. ) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms.
  4. ) Uncontrolled or symptomatic congestive heart failure ( \> NYHA class 2 ).
  5. ) The ejection fraction is lower than the lower limit of the normal range.
* Researchers evaluated that is not suitable for the group.
Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:

We have been using DEX for refractory DME for a long time (since 2016). Thus, we are sharing our results , evaluating both anatomical and functional outcomes of DEX therapy for refractory DME.

Our study aims at evaluating both anatomical and functional outcomes of DEX therapy for cases of refractory DME, with both a single injection, and /or with retreatments.

Eligibility Criteria:
Inclusion Criteria:

* • Age: 16 or older (Adults)

  * Sex: both
  * NTDME with CMT \>300 u
  * \< 10% reduction in CMT (than previous treatment)
  * \< 50 u reduction in CMT (than previous treatment)
  * Worsening of BCVA \> 1 line on E chart.
  * Duration since Previous treatment is: 3 months with DEX, 1 month with Anti-VEGF
  * Pseudophakic eyes
  * NPDR , PRP-treated PDR

Exclusion Criteria:

* • Phakic eyes

  * Uncontrolled Glaucoma (IOP \> 24 mmHg, or cup disc ratio 0.8 or more)
  * Herpetic viral infection.
  * Untreated PDR
Quality of Life After Esophagectomy for Cancer

The purpose of the current study is to assess the role of pyloric drainage procedure on altering the reflux effect on the quality of life in patients who underwent esophagectomy. Researchers hypothesize that the patients who underwent minimally invasive esophagectomies without pyloric drainage experience less reflux symptoms and therefore have a better quality of life.

Surgery is considered curative for patients with esophageal cancer. The minimally invasive approach was developed such that laparoscopy and thoracoscopy replace large abdominal and thoracic incisions. For both open and minimally invasive procedures, patients have many adjustments to overcome in order to regain quality of life that is within the norm. In a recent study on the health-related quality of life (HRQL) after curative surgical resection, symptoms of reflux was the only variable that worsened with statistical significance.

The study plan is to retrospectively compare two groups of patients: those who underwent esophagectomy with pyloric drainage procedure and those who did not. The study will be done using all MD Anderson patients who underwent minimally invasive esophagectomies, in which pyloroplasty and pyloromyotomy are not standard procedures. Clinically relevant data and demographic information will be collected retrospectively for the two groups including age, gender, Body Mass Index, level of anastomosis, and time elapsed since surgery. All patients will be interviewed via telephone. At least two attempts will be made to contact each patient.

Eligibility Criteria:
Inclusion Criteria:

1. patients who are 18 years-old or older
2. Patients who received esophagectomy indicated for primary esophageal cancer, either adenocarcinoma or squamous cell carcinoma
3. Patients who received minimally invasive or transthoracic or transhiatal or three-field esophagectomy at MDACC during or after 2004
4. Patients who are English-speaking and of any ethnicity
5. Patients with prior cancers, any clinical stage of esophageal carcinoma, any performance status (as rated by American Society of Anesthesiologist Risk Scale), received or did not receive preoperative treatment, had level of anastomosis in either neck or chest

Exclusion Criteria:

1) Patients who received esophagectomies indicated for emergency, salvage or redo
Adjuvant IMRT With Concommitant Raltitrexed Chemotherapy for Locally Advanced Gastric Cancer After D0/D1 Radical Resection

The purpose of this study is to determine whether raltitrexed concurrent with IMRT is safe, tolerable and effective in the treatment for patients with local-advanced gastric cancer after D0/D1 radical resection.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent signed.;
2. Age: 18-70 years old, sex is not restricted;
3. Pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; did not receive neoadjuvant chemotherapy or radiotherapy before surgery;received the 2-3 cycles of chemotherapy of FOLFOX regimens or 1-2 cycles of XeLOX or SOX regimens after operation;
4. Received D0 or D1 operation, no tumor residual (R0);
5. Postoperative pathological stage of pT3N0, pT4N0 or any T, N1-2, without distant metastatic disease;
6. ECOG 0-2;
7. Normal blood analysis: WBC≥3.5 X 109/L, GRAN≥2.0 X 109/L = 2, Hb≥90g/L, PLT≥100 X 109/L;
8. Liver function: ALT or AST is less than or equal to 2.5 times of the normal high value (ULN); bilirubin is less than 1.5\*ULN, serum APK is less than 2.5 \* ULN;
9. Renal function: serum creatinine is less than 1.5 \* ULN, and creatinine clearance rate is more than 60ml/min;
10. No previous chemotherapy or radiation therapy history;
11. No organ transplant history;
12. Urine pregnancy test results are negative for women of childbearing age in the first 7 days and not in lactation before treatment;
13. Men and women of childbearing age agreed to adopt reliable methods of contraception for 30 days before , during and after the course of the study

Exclusion Criteria:

1. Received D2 radical operation;
2. Tumor residual (R1/R2);
3. There was found evidence of distant metastasis (M1) or suspicious metastasis after examination;
4. Other cancer history, except skin basal cell carcinoma or cervix in-situ carcinoma;
5. Previously received chemotherapy or other systemic anticancer therapy, including cytotoxic drugs, targeted drugs; or had received abdominal radiotherapy;
6. Anticipate other clinical trials in four weeks before enrollment.
7. Severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes, severe cardiac arrhythmia, etc.
8. Drug abuse history or alcohol addiction;
9. Active infection existed.
10. with severe malnutrition or severe anemia;
11. Human immunodeficiency virus (HIV) infection;
12. Pregnancy (confirmed by serum or urine beta -HCG test) or during lactation;
13. Can not tolerate this study or may be allergic to the drug used in this study;
14. Persons who have no or restricted capacity for civil conduct; or have mental illness, whom the researchers believe can not fully understand the possible complications of this study.
Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease

Strategies to stop AKI-AKD-CKD continuum - Policy is one of the collaborative projects, Strategies to stop AKI-AKD-CKD continuum, Epidemiology, Immunology, Repair, Artificial intelligence, and Policy (EIRAP). It is aimed to study effective interventional strategies that lower the incidence of CKD among patients with AKD. The intensified AKD care to reduce CKD (ISACC trial) is a prospective, open-labeled, randomized controlled trial is designed to evaluate the efficacy of multidisciplinary team care (MDT) model and acute kidney disease (AKD) clinic visits

Acute kidney disease (AKD), defined as the ongoing renal function impairment between 7 days and 90 days following AKI, has been proposed as a window of intervention to prevent the occurrence of CKD. However, the effective therapeutic strategies of AKD care remain to be developed. We intend to conduct a prospective, randomized, open-label, behavioral interventional trial to validate the efficacy of multidisciplinary team (MDT) care model which aims to improve AKD care and to reduce de novo CKD incidence.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 yrs
* Severe AKD: Stage 2, Stage 3 and Dialysis-requiring AKD (AKD-D)

Exclusion Criteria:

* Pregnancy
Abdominal Hypopressive Technique on Postpartum Low Back Pain

Postpartum Low back pain (PP-LBP) is more common and can lead to limitations to women's daily activity. Pregnancy related low back pain has been reported to occur in 55% to 78% women worldwide.This study is planned to determine the effects of abdominal hypopressive technique on postpartum low back pain, mobility and disability.

literature suggests the use of hypopressive abdominal techniques to be effective in increasing the thickness of the abdominal muscles and hence add to the stability of the spine and alleviation of low back pain in the postpartum period. This will be a randomized controlled trial, with two groups.

Participants in the experimental group will learn how to perform the "hypopressive maneuver", which consisted of exhaling to their expiratory reserve volume, then holding their breath (apnea), and expanding their rib cage, to draw their abdominal wall inward and cranially without inhalation. control group will perform general exercises. Both groups will be assessed at pre and post test (after 6weeks)

Eligibility Criteria:
Inclusion Criteria:

* Postpartum non-radiating low back Pain
* LBP severity \>3 on numeric pain rating scale (NPRS)
* Spontaneous vaginal delivery

Exclusion Criteria:

* Prenatal history of low back pain
* Caesarean section
* Hypertension
* Puerperium period
* Arterial complications
* Neurological deficit
* Disc Bulge
* Lumbar Radiculopathy
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1.

Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* HCV RNA ≥ 10,000 IU/mL at screening
* HCV genotype 1 or 4
* HIV-1 infection
* Cirrhosis determination, a fibroscan or liver biopsy may be required
* Screening laboratory values within defined thresholds
* Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male

Exclusion Criteria:

* Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol
* Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC), or other malignancy (with the exception of certain resolved skin cancers)
* Hepatitis B virus (HBV) infection
* Pregnant or nursing female
* Chronic use of systemically administered immunosuppressive agents