cyrilzakka/clinical-trials huggingface dataset:
ROOD's Sensory Motor Training in Sub-acute Stroke

The aim of this randomized controlled trial is to determine the effects of ROOD's sensory motor training along with Constraint Induced Movement Therapy (CIMT) in sub-acute stroke. Two randomized groups of patients with stroke were treated with conservative physical therapy and the experimental group was given ROOD's SMT and CIMT in conjunction with conservative rehabilitation. Both, male and female patients meeting the inclusion criteria were included. Patients having other neurological disease, chronic disease, not compatible being participates in CIMT or with any surgical intervention were excluded.

The study is aimed at determining the effects of ROOD's sensory motor training along with constraint induced movement therapy in sub-acute stroke and is being conducted in National Institute of Rehabilitation Medicine Islamabad and Pakistan Railway General Hospital, Rawalpindi (Feb 2019-July 2019). Sample size of the study is 36 patients, 36 were included in the study on the basis of inclusion criteria, 18 for each group. Patients were allocated randomly and equally in each group. Similar conservative rehabilitation protocol was designed for both control and experimental group except for experimental group had ROOD's sensory motor training and CIMT training. Patients were examined at 1st visit before administration of any treatment and at 6th week which was also the last one (after completing 6 weeks sessions at alternate days). Baseline evaluation for demographics and assessment was taken. Fugyl-meyer assessment scale(FMA) and Wolf motor function test(WMFT) as measuring tools were used for first and 6th week assessment. 29 patients completed the study while 4 patient from control group and 3 patients from experiment group were lost to follow up and were considered drop outs.

Eligibility Criteria:
Inclusion Criteria:

* Right \& Left hemiplegia
* Ischemic \& Hemorrhagic stroke
* Compatible with being participate in CIMT i.e. 10ºwrist extension,10ºany two fingers extension,10ºthumb abduction
* Duration of stroke between 6 weeks to 6 months

Exclusion Criteria:

* Not compatible with being participate in CIMT
* Any other neurological disease e.g. Parkinson's disease, brain tumors
* Chronic disease e.g. Ischemic Heart Disease, tumors, Diabetes Mellitus
* Behaviors issues, not willing to participate
* Surgical intervention that hinders treatment and assessment
* Not well oriented to follow designed motor task
Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients with Detrusor Overactivity

To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.

Patients with detrusor overactivity who were refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study. Patient were divided in two groups, intradetrusor onabotulinumtoxinA injection and combined pharmacotherapy with Mirabegron and Solifenacin. Incontinence-related symptoms distress and impact on quality of life were evaluated by short form of Urinary Distress Inventory, (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Overactive Bladder Symptom Score (OABSS). Objective outcomes include changes from baseline in daily urgency episodes, urinary incontinence episodes, maximum cystometric capacity, maximum detrusor pressure (Pdetmax) at first involuntary detrusor contraction and volume at first involuntary detrusor contraction were measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. Those who were refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study

Exclusion Criteria:

* Postvoid urine retention before treatment
NAC for Hematopoietic Recovery in SAA

This is a prospective single-arm clinical study to evaluate the role of NAC among patients with severe aplastic anemia (SAA) can promote hematopoietic recovery after haploidentical transplantation.

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment of severe aplastic anemia (SAA). However, poor hematopoietic reconstitution including poor graft function (PGF) and prolonged isolated thrombocytopenia (PT), remains a life-threatening complication after allo-HSCT. Especially with the increasing use of haploidentical allo-HSCT (haplo-HSCT) in the past ten years, PGF and PT have become growing obstacles contributing to high morbidity and mortality after allo-HSCT. A previous clinical prospective cohort study showed that NAC could improve the function of bone marrow endothelial progenitor cells and promote hematopoietic recovery among leukemia patients after haploidentical transplantation. Therefore, we hypothesized that the prophylactic administration of NAC could facilitate the recovery of hematopoietic capacity by improving the bone marrow microenvironment of patients with SAA after haploidentical transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with SAA or vSAA
2. Aged 18-50
3. No severe organ injury
4. No uncontrolled active infections
5. Sign informed consent form, have the ability to comply with study and follow-up procedures

Exclusion Criteria:

1. Hypersensitivity to NAC or history of bronchial asthma
2. Life expectancy less than 30 days post-transplantation
3. Uncontrolled infections pre-transplantation
4. Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
5. Respiratory failure ( PaO2 ≤60mmHg)
6. Hepatic abnormalities (total bilirubin ≥2 times the upper limit of normal \[ULN\], alanine aminotransferase or aspartate aminotransferase ≥2 times the ULN)
7. Renal dysfunction (creatinine ≥1.5 times the ULN or creatinine clearance rate \< 30 mL/min)
8. ECOG performance status ≥3
9. With any conditions not suitable for the trial (investigators' decision)
Observational Study of Durvalumab in Patients With Non-small-cell Lung Cancer in the United Kingdom

This is a retrospective observational research study to describe the characteristics and real-world clinical outcomes of patients with locally advanced, unresectable Stage III non-small cell lung cancer receiving durvalumab in the United Kingdom (the CODAK study). Physicians who have treated patients who have locally advanced, unresectable Stage III NSCLC with durvalumab will be requested to recruit patients to have their clinical data abstracted from their clinical records in line with local laws. Data from this study will provide UK-specific real-world data on patients receiving durvalumab through the Early Access Programme (EAP) or post-reimbursement.

Primary Objectives

The primary study objectives, in patients with locally advanced, unresectable Stage III NSCLC treated with durvalumab as part of the UK EAP or non-EAP, are:

1. To describe clinical outcomes
2. To describe the patient demographic and clinical characteristics Secondary Objective

1. To describe treatment patterns of durvalumab

Eligibility Criteria:
Inclusion Criteria:

* Patient has documented diagnosis of locally advanced, unresectable Stage III NSCLC
* Patient has received platinum-based CRT and received ≥1 dose of durvalumab
* Patient was initiated on durvalumab (index event) between 1st September 2017 and 31st December 2019 via the EAP or non-EAP
* Patient was aged ≥18 years at durvalumab initiation

Exclusion Criteria:

* Patients who participated in the PACIFIC-R study
* Participation in any clinical study with an investigational product at the time of durvalumab initiation or during the observational period
Sleep Intervention

A trial that tests whether implementation intentions improve sleep among adoelescents.


Eligibility Criteria:
Inclusion Criteria:

* Aged 12-16 years

Exclusion Criteria:

* Unable or unwilling to complete the question
Bleeding Pattern Difference Between Levonorgestrel Intrauterine System (LNG-IUS) and Copper Intrauterine Devices (IUDs) Immediately Inserted After Abortion

To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Reproductive women in good general health and requesting long-term contraception
* Applied the Cu-IUD or LNG-IUS immediately after first trimester surgical abortion
* History of regular cyclic menstrual periods
* Written ICF was obtained

Exclusion Criteria:

* Suspected septic abortion and incomplete abortion, as well as missed abortion
* The contraindications and warnings of the respective Summary of Product Characteristics of Mirena or prescribing information of Cu-IUDs must be followed
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)

* This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in healthy subjects
* MR Perfusion Imaging will be assess in both cochlea as well
* Primary auditory brain pathways will be evaluated through MR diffusion imaging


Eligibility Criteria:
Inclusion Criteria:

* Major subjects of over 40 years (mean age of Meniere's disease 40 to 50 years)
* Informed consent signed
* Medical examination performed prior to participation in research
* Patients without history of inner ear disease
* Recipient of a French social security scheme

Exclusion Criteria:

* Patients minors
* Patients on a legal protection regime type guardianship
* Respiratory pathologies, cardiovascular, renal, diabetes
* Claustrophobia
* Contraindications to exposure to a magnetic field
* Contraindications to injecting Dotarem ®
Behavioral Maintenance Treatment for Smoking Cessation

Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. The investigators will also conduct secondary analyses of mediators and moderators of treatment response.

400 adult smokers will be randomized. Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. All smokers will receive the same "Acute Phase Treatment" that combines nicotine patch, bupropion and intensive self-regulatory skills training. Nicotine patches will be provided for 8 weeks and bupropion and skills training will be provided for of 9 weeks. Participants will then enter a "Maintenance Treatment Phase" during which half (n=200) will receive three individualized relapse prevention training sessions spread over a 12 week period. They will also receive 12 weeks of self-administered RPT administered via written treatment modules. Finally, telephone counseling will be provided in conjunction with an Interactive Voice Response system (IVR) that will allow early detection of smoking "slips" and rapid response by treatment staff. The other half (n=200) will be assigned to a control condition that consists of three counselor-led sessions of "supportive therapy" spread over a 12 week period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult cigarette smokers smoking at least 10 cigarettes per day

Exclusion Criteria:

* Currently pregnant
* Currently breastfeeding
* Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure
* History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
* Family history of seizures
* Currently using intravenous drugs
* Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
* Currently using any over-the-counter stimulants and anorectics (diet pills)
* Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
* Currently on NRT or bupropion (Zyban)
* Current or past diagnosis of anorexia nervosa or bulimia nervosa
* Previous allergic response to bupropion or NRT
* Previous failed quit attempt using NRT and bupropion in combination
Electrophysiological Study of Spatiotemporal Gait Parameters in Patients in Early Stage of Multiple Sclerosis

35 patients with multiple sclerosis have been enrolled in a previous study to record and analyze gait parameters.

This study aims to enroll gender and and matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'.


Eligibility Criteria:
Inclusion Criteria:

* subjects without any gait trouble
* age ≥ 18 and \< 55 years old
* gender and age (+/- 5 years) matched

Exclusion Criteria:

* pathology with potential gait impairment
* pregnant or breast feeding patient
* patient under legal protection
* no health insurance coverage
* absence of written informed consent
Epidemiological Studies and Risk Factor Analysis of GERD in Xiamen City

Gastroesophageal Reflux Disease (GERD) is a condition characterized by the reflux of gastric and duodenal contents into the esophagus, primarily manifested by symptoms such as acid regurgitation and heartburn. GERD significantly affects patients' daily lives and health-related quality of life. Prolonged gastroesophageal reflux can lead to repeated irritation of the esophageal mucosa by gastric acid and acidic gastric contents, resulting in the replacement of normal squamous epithelium in the lower esophagus with metaplastic columnar epithelium. This pathological change, known as Barrett's Esophagus (BE), is considered a precancerous lesion for esophageal adenocarcinoma.

GERD is a common gastrointestinal disorder with numerous risk factors that negatively impact patients' quality of life. Abnormal psychological conditions may influence various aspects of GERD, including its onset, diagnosis, treatment, and prognosis. The incidence and risk factors of GERD vary in different countries or regions. Currently, there is a lack of unified national epidemiological data on GERD in China. Conducting epidemiological studies on GERD in China to identify risk factors and develop prevention and treatment measures tailored to the country's or specific regions' circumstances is crucial for reducing the incidence of GERD and improving patients' quality of life.

In the context of the modern biomedical model of "biopsychosocial" health, actively researching the psychological conditions of patients, while also addressing their physical ailments and providing psychological treatment, emphasizes holistic care. This approach may comprehensively alleviate disease symptoms and enhance quality of life, potentially leading to new breakthroughs in the treatment of GERD.

Based on this, a specialized cohort for gastroesophageal reflux disease will be established, along with multicenter epidemiological and clinical research in the Xiamen area. This initiative will help clarify the etiology of GERD and provide firsthand resources for evidence-based prevention and treatment.

Eligibility Criteria:
Inclusion Criteria:

* All patients had experienced typical reflux symptoms, i.e., mild heartburn and/or regurgitation symptoms, for at least 2 days per week or moderate/severe reflux symptoms for more than 1 day per week during the previous 3 months and had upper endoscopy examinations in the previous month.
* Cooperate with the questionnaire survey.
* Volunteer and sign the informed consent form.
* Permanent residents in Xiamen.

Exclusion Criteria:

* Malignant tumor.
* Partial or total gastrectomy.
* Failing to cooperate with the investigation because of the factors such as education level and language intelligence disorder, etc.
* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine and mental system diseases.
* Patients with mental retardation, etc.
The Effect of Fetal Gender on Maternal Substance Abuse Treatment

Previous studies by this team of investigators has determined that male infants are more likely to display more severe neonatal abstinence syndrome (NAS) as a result of maternal opioid use during pregnancy (Jansson, 2007)and there is appears to be a gender-related biologic vulnerability to NAS expression (Jansson, 2009, submitted). The proposed study explores the relationship between fetal gender and substance abuse treatment outcomes among a population of women in comprehensive substance abuse treatment to explore the possibility of a psychosocial vulnerability among drug exposed male fetuses as opposed to female fetuses. Women in substance abuse treatment are a group at high risk for current exposure to violence, usually at the hands of significant others, and having a history of sexual abuse as a child, usually resulting from contact with a male family member. Therefore, they often have difficult relationships with men. At the Center for Addiction and Pregnancy (CAP), a 2006 study revealed that among a group of 715 pregnant women, reports of the exposure to violence was very high. Their rates of lifetime abuse ranged from 72.7% for physical abuse to 44.5% for sexual abuse. Rates of abuse remained high during their current pregnancy, ranging from 20% for physical abuse to 7.1% for sexual abuse (Velez, 2006). The abuse was very often at the hands of partners or other male family member perpetrators. We hypothesize that women carrying male fetuses will be less likely to remain complaint in drug treatment or abstinent from illicit drug use, while women carrying female fetuses may be more likely to remain drug abstinent and treatment compliant. If supported, this theory has the potential to inform fetal gender specific treatment for pregnant drug dependent women. Additionally, we seek to support the previously documented link between male gender and more severe expression of NAS, and explore the relationship between other maternal prescribed drug use (i.e. psychotropic medications) and severity of NAS expression.


Eligibility Criteria:
Inclusion Criteria:

* All CAP clients who either experience a pregnancy loss, or deliver an infant while in treatment at CAP between the years 7/1/03 and 6/30/08

Exclusion Criteria:

* All CAP clients who depart CAP treatment prior to pregnancy loss or birth during that time period
Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias

This study evaluates effect of anterior component separation and posterior component separation and transversus abdominis muscle release methods for treatment of midline ventral hernias.

The anterior component separation technique requires an extensive subcutaneous flap elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus sheath.

The posterior component separation technique utilized the retromuscular space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscles. Transversus abdominis muscle release dissected the posterior sheath back to the transversus abdominal muscle and accessed the space between muscle and trasversalis fascia.

Eligibility Criteria:
Inclusion Criteria:

* subject has midline ventral hernia
* patient's approval to participate in the study

Exclusion Criteria:

* strangulated hernia
* patient's preference for either operative technique
* patient's refusal to participate in the study
Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies

This study aims to observe the effectiveness of clinical application in guiding anti-infection treatments in AIDS patients with severe pneumonia and/or sepsis using Metagenomic Next-Generation Sequencing-based technology in the real world

The study focuses on AIDS patients with severe pneumonia and/or sepsis, divided into groups based on whether metagenomic next-generation sequencing technology is used in the real world or not. The groups are the metagenomic next-generation sequencing group and the conventional pathogen detection group, with metagenomic sequencing samples derived from blood specimens. The study compares the pathogen detection rates and clinical diagnosis conformity rates of the aforementioned groups, as well as the efficiency of diagnosis in guiding clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed HIV infection;
2. Progression to AIDS stage: CD4+ count \<200 cells/ul and/or occurrence of AIDS opportunistic infections;
3. Age between 18 and 65 years;
4. Meeting the diagnosis of severe pneumonia or septic shock:

   1. The criteria for severe pneumonia diagnosis refer to the 2021 ATS (American Thoracic Society) and IDSA (Infectious Diseases Society of America) guidelines for the treatment of community-acquired pneumonia;
   2. The criteria for septic shock refer to the Chinese Society of Critical Care Medicine's "Chinese Guidelines for the Emergency Treatment of Sepsis/Septic Shock (2018).

Exclusion Criteria:

1. Coexisting central nervous system lesions, severe liver disease, or cirrhosis;
2. Concurrent AIDS-related or unrelated tumors;
3. Women who are pregnant or breastfeeding;
4. Severe underlying diseases of the heart, lungs, liver, kidneys, etc.;
5. Alcohol abuse or drug use;
6. The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial.
Clinical Validation Study of RTVue Features

To perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology.

Clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology. Subjects to undergo a clinical exam and OCT scanning.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects will have normal results from the clinical exam and be free of ocular pathology.
* Glaucoma patients will have clinical exam results consistent with glaucoma; they will have visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.
* Retina patients will have clinical exam results consistent with retina pathology.

Exclusion Criteria:

* Normal subjects will be free of any ocular pathology.
* Glaucoma patients will be free of any ocular pathology except glaucoma.
* Retina patients will be free of any ocular pathology except any type of retina pathology.
Imagio Feasibility Multi-Reader, Multi-Case Study

Controlled, blinded, multi-reader, multi-case study

The Imagio Feasibility Reader Study-01 Study is intended to evaluate if a subsequent pivotal study can be implemented to test prospective hypotheses for pre-specified effectiveness endpoints with an acceptable sample size. The Feasibility Study will be based on ITD masses from the PIONEER (NCT01943916) Pivotal study to simultaneously reflect the distributions with and without mammograms as well as site CDU BI-RADS scores within benign and malignant masses as strata. The study population will be split into 3 cohorts - Cohort 1, the 120 patient ITD Population used to run the primary/ secondary analyses. Cohort 2, 30 patients used to run exploratory analyses on false negative rate and Cohort 3, 5 patients used to run exploratory analyses on specific mass types

Eligibility Criteria:
Inclusion Criteria:

- Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status

Exclusion Criteria:

- Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status