cyrilzakka/clinical-trials huggingface dataset:
Outcome Measures for Pediatric Wheelchairs in Low-resource Settings

Two wheelchair types available for children in Kenya are assessed for energy costs, utility, and complications. This study will arrive at a protocol for assessing wheelchairs in low-income settings, and in the process, provide wheelchair makers and providers with specific feedback. It also serves as a means to increase the skills of local health professionals working with the children in this study, while providing them with appropriate wheelchairs to use.

In each of 2011, 2012, and 2013, two different low cost wheelchairs were assessed. User feedback, health professional feedback, and objective measures were employed for these assessments in the real world setting. Participants for each phase were recruited from a Kenyan Primary or Secondary Schools for children with disability.

Eligibility Criteria:
Inclusion Criteria:

* Children who would benefit from available study wheelchairs who are able to provide feedback

Exclusion Criteria:

* Children who are not able to provide feedback on the study wheelchairs
Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa

Sperms are prepared by sperm washing techniques before used in assisted reproductive technologies. Most commonly used sperm preparation methods are the swim up and the density gradient. Recent studies shows that the DNA integrity status of the spermatozoa is related to the success in assisted reproduction techniques. Sperm preparation methods may theoretically cause damage to sperm DNA. Therefore it is important to select the optimum method of sperm preparation causing least sperm DNA damage. Aim of our study is to investigate and compare the effect two different sperm preparation techniques on DNA fragmentation.


Eligibility Criteria:
Inclusion Criteria:

Male factor subfertile group:

Couples of having at least two abnormal sperm analysis according to WHO criteria.

Unexplained subfertile group:

Couples with normal sperm parameters, plus females with normal ovulatory status and patent fallopian tubes by hysterosalpingography or laparoscopy.

No previous IVF or IUI attempts before the study

Exclusion Criteria:

Severe oligospermia (Sperm count \< 5 Millions/ per ml) Systemic diseases or therapies influencing DNA integrity for male partner
Sequential Versus Quadruple Therapy in the Second-line Treatment

Objectives: A recent randomized trial showed that 14-day sequential therapy containing high dose proton pump inhibitor was higher than 95% in the first line treatment. However, whether the 14-day sequential therapy is more effective than 10-day bismuth quadruple therapy remains unknown. Therefore, the investigators aimed to compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the second line treatment.

This will be a multi-center, open labeled, randomized comparative trial Patients: 240 patients with H. pylori infection who failed after first-line therapy will be eligible

Interventions: eligible patients will be randomized into one of the two groups Group (A): sequential therapy for 14 days (S14)

D1-D7: (esomeprazole 40mg bid + amoxicillin 1000mg bid) for 7 days

D8-D14: (esomeprazole 40mg bid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days

Group (B): bismuth quadruple therapy for 10 days (Q10)

D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days

Primary End Point: Eradication rate in the second line treatment according to intention to treat (ITT) analysis in the two treatment groups

Eligibility Criteria:
Inclusion Criteria:

* H. pylori infected patients who fail from first line standard triple therapy with clarithromycin, amoxicillin, and a proton pump inhibitor will be eligible in this study.

Exclusion Criteria:

Patients will be excluded from the study if any one of the following criteria was present:

* children and teenagers aged less than 20 years,
* history of gastrectomy,
* gastric malignancy, including adenocarcinoma and lymphoma,
* previous allergic reaction to antibiotics (bismuth, metronidazole, levofloxacin, tetracycline) and PPI (esomeprazole),
* contraindication to treatment drugs,
* pregnant or lactating women,
* severe concurrent disease, or
* Unwilling to accept random assignment of subjects.
Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-comers" Coronary Lesions （ULTIMATE Trial）

A number of 1448 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and IVUS imaging are openly randomized 1:1 to either IVUS guidance or angiographic guidance groups.

The study is prospectively conducted at 8 high-volume PCI centers in China with IVUS expertise. Clinic follow-up are planned in all patients 12 months after implantation of drug eluting stents. Primary endpoint is target vessel failure. The study is powered for primary endpoint, which are likely to reach significance at the level P \< 0.05 even at a follow-up drop-out rate up to 10%.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures;
* Men and women 18 years and older;.
* Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology;
* Native coronary lesion suitable for drug-eluting stent placement and IVUS imaging.

Exclusion Criteria:

* Pregnancy and breast feeding mother;
* Co-morbidity with an estimated life expectancy of \< 50 % at 12 months;
* Scheduled major surgery in the next 12 months;
* Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
* Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days;
* Known allergy against ticagrelor, or against clopidogrel, or aspirin History of major hemorrhage (intracranial, gastrointestinal, etc.);
* Chronic total occlusion lesion in either LAD, or LCX or RCA not re-canalized;
* Severe calcification needing rotational atherectomy；
* Patient with STEMI (within 24-hour from the onset of chest pain to admission).
Repetitive Behavior Disorders in People With Severe Mental Retardation

Repetitive behavior disorders are prevalent among people with severe mental retardation. These disorders can interfere significantly with an individual's daily functions. This trial is part of a long-term project that has studied the biologic basis of and possible treatments for repetitive behavior disorders. The trial will evaluate the effectiveness of two medications, a selective serotonin reuptake inhibitor (SSRI) and an atypical antipsychotic, in treating repetitive behavior disorders in people with mental retardation.

Abnormal repetitive behaviors (odd or inappropriate movements, self-injury, and compulsions) are among the aberrant behaviors exhibited by individuals with mental retardation. However, little is known about their pathobiology and treatments are largely unconfirmed by controlled trials. For example, few controlled studies have examined the efficacy of pharmacological treatment of abnormal repetitive behavior in individuals with mental retardation.

This trial is part of a larger project designed to elucidate the neurobiological bases of repetitive behavior disorders and to develop rational, safe, and effective pharmacological treatments. Thus far, the project has established a pathophysiological basis for stereotyped behavior disorder, demonstrated the role of central dopamine deficiency in stereotyped behavior disorder, and provided evidence of the efficacy of both 5-HT uptake inhibitors and atypical antipsychotics in treating stereotyped behaviors.

There is currently little information to guide the clinician in deciding which drug class may be more effective for which abnormal repetitive behaviors and for which individuals. Moreover, little work has attempted to identify variables that may predict differential treatment response. This trial will assess the relative efficacy of an SSRI and an atypical antipsychotic across multiple categories of abnormal repetitive behaviors.

Eligibility Criteria:
Inclusion Criteria

* Mental retardation
* Medically stable resident of either Western Carolina Center, Morganton, NC or Tacachale Community, Gainesville, FL
* Free of sensory deficits
* Ambulatory
* High rate of stereotyped behavior that may co-occur with self-injurious or compulsive behaviors

Exclusion Criteria

* Poor general health
* Cardiac, hepatic, or renal abnormalities
* Seizure within 4 months prior to study entry (patients on seizure medication who have not had a seizure within 4 months prior to study entry may participate)
* Tardive dyskinesia
* Akathisia
* Neuroleptic use within 6 months of study entry
* History of sensitivity to ergot alkaloids
* Hypertension
Pre-emptive Analgesics in Orthodontic Treatment

This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone.

This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone. Before their orthodontic appointment, participants will be administered acetaminophen (650mg), ibuprofen (400mg), or acetaminophen (650mg) + ibuprofen (400mg). Participants will be asked to record their pain intensity using a numerical (0-10) visual analog scale (VAS) during rest, light biting, and while chewing paraffin wax during the following time intervals: immediately following drug administration, 6 hours after, the morning after, and the second morning after orthodontic treatment.

Eligibility Criteria:
Inclusion Criteria:

-Orthodontic patient presenting for orthodontic treatment

Exclusion Criteria:

* History of taking an analgesic in the past six hours
* Hypersensitivity to ibuprofen or acetaminophen
* Aspirin-sensitive asthma
* Renal or liver impairment
* History of GI bleeding or ulcers
* Cardiovascular disease, recent myocardial infarction, heart failure, or coronary artery bypass graft surgery
* Currently taking antibiotics or other medications for a chronic systemic disease
* Bleeding disorder
* Pregnant or nursing
Characterizing the Scalp Tolerability of TMS

The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the knee as a surrogate location to safely trial tolerability of novel TMS parameters.


Eligibility Criteria:
Inclusion Criteria:

1. Adults ages 18 years and older.
2. Capable to give informed written consent, ability to understand study procedures, and ability to comply with procedures for the entire length of the study.
3. Individuals with and without prior exposure to TMS are eligible (including individuals who have received TMS to treat depression).

Exclusion Criteria:

1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
2. Contraindication for scalp sensitivity and tolerability testing (e.g., sunburn, active headache, history of frequent and severe headaches).
3. Contraindication for knee sensitivity and tolerability testing (e.g., current knee injury or ongoing complications from prior history of knee surgery), unless knee testing skipped at the investigators' discretion.
4. Contraindication for participants with metal in both knees, unless knee testing skipped at the investigators' discretion.
5. Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
6. Dementia or other cognitive disorder making unable to engage in study.
7. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness.
8. Taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.).
9. Any medication or substance use that significantly impacts sensory and tolerability measures based on the investigators' review of dosing and effect (e.g., topical anesthetics, botulinum toxin injections, ketamine, NSAIDS, opioids, anticonvulsants used in pain management, etc.).
10. Current, planned, or suspected pregnancy.
11. Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.).
12. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).

The investigators will exclude the following individuals:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Therapeutic Effects of Liver Failure Patients Caused by Chronic Hepatitis B After Autologous MSCs Transplantation

The study aimed to investigate the short-term efficacy and long-term prognosis of liver failure patients caused by hepatitis B after single transplantation with autologous marrow mesenchymal stem cells (MMSCs). Liver failure inpatients caused by hepatitis B were recruited and received the same medical treatments, among whom some patients underwent single transplantation with autologous MMSCs and other patients with matched age, gender and biochemical indexes \[alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT) and Model for End-stage Liver Disease (MELD) \] were in control group. A total of 120 ml bone marrow were obtained from patients, diluted and separated. Then MMSCs suspension were slowly transfused into the liver through the proper hepatic artery by interventional procedures. The levels of ALB, TBIL, PT and MELD score of patients in translation group were compared with those in control group. In 3 \~ 48 months of follow-up, differences in long-term outcomes such as incidence of HCC (hepatocellular carcinoma) and mortality between two groups were compared.

A total of 527 patients with chronic hepatitis B induced liver failure were recruited from May 2005 to June 2009 from our department. The diagnoses of chronic hepatitis B and liver failure were based on previously described criteria. All patients received the same medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin). Informed consent was obtained before study. Among these patients, 53 received transplantation with autologous MMSCs. The day of surgery served as the first day of observation. And 105 patients with matched age, gender and some biochemical indexes (ALT, ALB, TBIL, PT and MELD ) were served as controls.

Eligibility Criteria:
Inclusion Criteria:

* Liver failure

Exclusion Criteria:

* HBV negative
Lymphocyte Enhancement in Gastroenteric Oncology

LEGO is single center double-blind randomized trial aimed at testing the efficacy of an essential ammino acid (EAA) supplementation in improving the absolute count of peripheral lymphocytes and the tolerance to chemotherapy in patients with advanced gastrointestinal malignancies not candidates to immune check-point inhibitors containing regimens.

The aim of the study is to verify that, in lymphopenic patients, AAE supplementation leads to an increase in lymphocytes circulating in the blood. In particular, at the end of treatment, in patients with lymphocytes \< 29.7% of the total number of white blood cells, we want to observe the disappearance of lymphopenia.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of epithelial neoplasia of the gastrointestinal tract in advanced stage with indication for first-line chemotherapy for palliative purposes and with circulating lymphocytes \< 29.7% of the number total white blood cells in the blood.
* ECOG PS ≤ 2
* start of first-line palliative chemotherapy agreement with AIOM guidelines.
* adequate nutritional counseling carried out before starting of the treatment
* willing to participate by providing written informed consent

Exclusion Criteria:

* age \< 18 years
* current or indicated artificial nutrition
* gluten intolerance
* prediction of use of granulocyte growth factors
* confirmed diagnosis of COPD, chronic heart failure, insufficiency chronic kidney disease, chronic liver failure, collagen disease, diseases endocrine, insulin-dependent diabetes, malignancy in other locations. All these conditions are associated with documented alterations in the plasma profile of amino acids and potentially of subsets of circulating T lymphocytes.
Machine Learning for Recurrence Risk of Pancreatic Cancer After Radical Resection

Recurrence of Pancreatic Cancer(PCa) is a multifactorial event. Based on the clinicopathological characteristics and imaging data of patients with PCa, the investigators used image processing and machine learning algorithms to build a more comprehensive and robust model, and added some unused features to explore its clinical application value.

A retrospective analysis of patients with PCa who underwent radical resection at Zhejiang Cancer Hospital (Hangzhou, China) from January 2013 to December 2020. The database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing radical PCa surgery in the investigators' hospital. The investigators used the PyRadiomics platform to extract image features.


Eligibility Criteria:
Inclusion Criteria:

* Have the results of enhanced CT examination of the pancreas within 1 month before surgery in our hospital;
* Radical resection of pancreatic cancer was performed in our hospital;
* There are follow-up results in our hospital, and the follow-up endpoints include disease recurrence or at least 12 months.
* Complete clinical medical records and imaging data.

Exclusion Criteria:

* non-R0 resection;
* Combined with other malignant tumors
* The patient's imaging data has technical problems or the lesion is too small (less than 1cm), which is not suitable for omics analysis.
Lorazepam Effects on Neuroimaging Measures

This within-subject, double blind, randomized controlled study will investigate the effects of a widely used benzodiazepine (BZD), lorazepam, on various neuroimaging measures. The investigators will be assessing the relationship of lorazepam to resting state functional connectivity and other neuroimaging measures. Specifically, the investigators will be using a pre-identified metric, the striatal connectivity index (SCI), (Sarpal et al. 2015, 2016), a prognostic biomarker of treatment response assessing the connectivity between regions of the striatum and the cortex. The investigators hypothesize that lorazepam administration will be associated with greater SCI values compared with placebo administration; consistent with previous work suggesting short-acting benzodiazepines increase functional connectivity across brain networks.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18-40
4. In general good health as evidenced by medical history
5. Ability to take oral medication and be willing to adhere to the study medication regimen
6. For women of reproductive potential, negative pregnancy test and agreement to use a medically accepted birth control method.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Pregnancy or lactation
2. Contraindications to MR imaging (i.e. pacemaker)
3. Known allergic reactions to components of the lorazepam
4. Current smoker or tobacco use
5. Concurrent use of any psychotropic medications, anticonvulsants, opioids or any other medication with effects on the CNS.
6. Acute narrow-angle glaucoma
7. Current or past history of a substance use disorder and/or a positive urine toxicology test.
Influence of TMS on Attention Modulation

The purpose of this study is to help understand how attention processes influence brain engagement during emotion and social cognition. The investigators also want to know if these processes are associated with drinking alcohol.

Participation includes three study visits of about 2 hours each over approximately a month. The first visit involves a magnetic resonance imaging (MRI) scan and answering survey questions. Each of the next two visits will involve a session of transcranial magnetic stimulation (TMS, a non-invasive brain stimulation technique) followed by another MRI scan.

People in the Auburn/Opelika area 19 or older are eligible to participate. People who drink alcohol and people who do not drink or don't drink very much are invited to participate.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or Older

2A. (Drinker Group): Reports consuming 4 \[if female\]/ 5 \[if male\] or more standard drinks on one occasion at least 2 times a month AND/OR reports consuming more than 7 \[if female\]/ 14 \[if male\] standard drinks per week on average

2B. (Healthy Volunteer Group): Reports consuming 4 \[if female\]/ 5 \[if male\] or more standard drinks on one occasion less than once a month AND reports consuming less than 7 \[if female\]/ 14 \[if male\] standard drinks per week on average

Exclusion Criteria:

1. MRI Contraindications

   1. Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos)
   2. Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr
   3. Hearing loss, including tinnitus, that might be made worse by MRI or TMS
2. TMS Contraindications

   1. Has ever had a seizure, or has a family history of epilepsy
   2. Taking medications or substances that lower the seizure threshold\*
   3. Implanted devices that are in the head or rely on physiological signals
   4. History of neurological disease, such as stroke or brain tumor
   5. Head injury with loss of consciousness greater than 30 minutes
   6. Actively withdrawing from alcohol
3. Family history of schizophrenia or presence of psychotic symptoms