cyrilzakka/clinical-trials huggingface dataset:
Bilateral Movement Training for People With Stroke

The investigators hypothesized that bilateral handgrip force training would result in significant improvements in paretic hand, arm movements and daily functional performances. In order to investigate whether the improvement of paretic hand could facilitate the motor recovery of paretic arm and functional performances, the investigators also hypothesized that motor recovery and functional performances improvements of paretic arm and hand have strongly correlation.

Objective: To investigate the training effects of interlimb force coupling training on paretic hand and upper extremity outcomes in patients with chronic stroke; to analyze the relationship between motor recovery of paretic hand, arm and functional abilities.

Design: A double-blind randomized controlled trial with outcome assessment at baseline and after 4 weeks intervention.

Setting: Department of physical medicine and rehabilitation in Taipei Veterans General Hospital.

Participants: Thirty-three subjects (mean age = 55.1 ± 10.5 y/o) with chronic stroke were recruited and randomized assigned to training (n=16) and control group (n=17).

Interventions: Interlimb force coupling training task included different gripforce generation on the both hands.

Main Outcome Measures: Barthel Index (BI), and the upper extremity motor control of Fugl-Meyer Assessment (FMA-UE), Motor Assessment Score (MAS), and the Wolf Motor Function Test (WMFT). All assessment was executed by a blinded evaluator, and data management and statistical analysis was also conducted by a blinded statistic researcher.

Eligibility Criteria:
Inclusion Criteria:

1. at least 6 months since stroke
2. three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history ability to follow researcher's instructions
3. ability to flex and extend the paretic arm and hand
4. Modified Ashworth Score (MAS) ≦3 for wrist and finger joints
5. Mini-Mental State Examination (MMSE) score should 24 or higher
6. no other orthopedic neurological disorders
7. Brunnstrom stage 3 or 4
8. no joint in other experimental rehabilitation or drug studies 21

Exclusion Criteria:

1. unstable cardiovascular conditions
2. uncontrolled hypertension (190/110 mm Hg)
3. severe orthopedic or pain conditions
4. dementia (Mini-Mental State Examination score \< 22)
5. aphasia with inability to follow researcher's commands
6. severe joint contracture of bilateral upper extremities that would impact the movement performances of upper extremities
Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions

Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa.


Eligibility Criteria:
Inclusion Criteria

* Signed informed consent
* Greater than 18 years of age
* Proof of breast cancer, multiple myeloma or prostate cancer
* Diagnosis of at least one cancer-related bone lesion
* If patient is of child-bearing potential, negative pregnancy test and on a medically recognized form of contraception
* ECOG performance status of 0,1 or 2
* Ability to read, understand and write English or Spanish language
* Normal renal function
* Corrected serum calcium equal to or greater than 8mg/dl Exclusion Criteria
* clinically symptomatic brain metastases
* hypersensitivity to Zometa or other bisphosphonates
* pregnant or lactating
Vaginal Microbiota Among Postmenopausal Women

It is known that vaginal bacteria have an impact upon the health status of the host, in some cases protecting against infection and in other cases causing infection, depending on the bacterial types present. This study will compare the composition of vaginal bacteria to symptoms of vaginal dryness in order to try and identify if certain bacteria might cause some of the problems associated with vaginal dryness among post-menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Between 30 and 80 years old.
* Postmenopausal = 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
* Prepared not to take hormone replacement therapy during 8 weeks follow-up and not taking estrogen alone or estrogen/progestin containing drug products at the time of screening.
Effects of the Interventions Using Multiple Sensory Integrations on Preterm Infants' Stress-Related Outcomes

Frequent pain and distress may affect infants' brain and neural development, and highlight the need for relieve pain interventions. Peripheral venous puncture procedures are an important source of preterm infants' pain and distress. Brain development is mainly created by infant sensory experience. It becomes important, therefore, to relieve preterm infants' pain and distress using multiple sensory integrations during peripheral venous puncture procedures.The proposed 2-year study has specific aim: to compare the effects of different combination of sensory integrations on preterm infants' pain and distress before, during, and after peripheral venous puncture procedures.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age (GA) 28-37 weeks
* Post-menstrual age (PMA) 29-38 weeks
* Postnatal age 3-28 days
* Sable condition (NTISSscore ≦ 22)
* Apgar scores≧7 at 5 minutes after birth

Exclusion Criteria:

* Neurologic impairment
* Congenital anomalies
* Surgery
* Severe growth restriction at birth
* Severe medical conditions requiring treatments
Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population

The purpose of the pilot study is to compare new laryngoscopes for infants by assessing the equipment best suited to assist the intubation, with the best overview, shortest time to intubation and use these numbers to make a sample size calculation for the full protocol. The investigators hypothesis is that the Storz videolaryngoscope® has a better success rate than infants (\<2 years). The patients will be optimally anaesthetized with neuromuscular blockade for the intubation. All patient will be evaluated with af Macintosh blade laryngoscope, with an Airtraq® or a Storz videolaryngoscope®, and finally intubated with the other one of the later, which the patient was randomized to.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgical patients ASA-class 1-2 below the age of 2 years, with indication for intubation.
* Informed consent from parent.
* The parents must have legal custody of the child.
* The parents must be able to read and understand Danish.

Exclusion Criteria:

* Expected difficult airway.
Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section

The patients were recruited from women attending labor ward to undergo cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Women with one or more of the following conditions undergoing cesarean section for obstetric indication were included:
* Maternal anemia (not less than 7 gm %).
* Macrosomic baby \>4kgs.
* Twin pregnancy and high order pregnancy.
* Polyhydramnios.
* Grand multipara.
* Previous history of atonic postpartum hemorrhage.
* Prolonged vaginal delivery.
* Emergency cesarean.
* Chorioamnionitis.

Exclusion Criteria:

* - Placenta previa.
* Patients with bleeding tendency (congenital or acquired)
* Ante-partum hemorrhage.
* Patients with no risk for uterine atony.
Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis

IPXELOX will investigate the safety, tolerability, and antitumor activity of intraperitoneal paclitaxel in combination with chemotherapy in patients with advanced gastric cancer with peritoneal metastasis.

Study hypotheses: Intraperitoneal paclitaxel administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and anti-tumor efficacy with systemic capecitabine and oxaliplatin in advanced gastric cancer with peritoneal metastasis.


Eligibility Criteria:
1. Inclusion Criteria:

   * ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1
   * pathologically proven primary gastric adenocarcinoma
   * peritoneal metastasis confirmed by laparoscopy or diagnostic imaging
   * written informed consent
   * adequate function of important organs (within 14 days before registration)

   Absolute neutrophil count ≥1.5 x 10\^9/L, Platelet \>=100,000/mm3, Hemoglobin \>=8.0g/dL, Total bilirubin \<= ≤ 2.0mg/dl or ULN(Upper Limit of Normal) x 1.5, AST(aspartate aminotransferase) \<=100IU/L(International Unit/Liter), ALT(alanine transaminase) \<=100IU/L, Creatinine clearance ≥ 50mL/min (milliliter/minute),
2. Exclusion Criteria:

   * other active concomitant malignancies
   * HER2(human epidermal growth factor receptor 2) positive (Immunohistochemistry 3+ or 2+ with in situ hybridization positive)
   * no investigational anticancer therapy within 30 days prior to the first dose of study treatment
   * recent (within 6 months) acute coronary syndrome, severe heart failure or severe pulmonary disease
   * uncontrolled acute or chronic disease
   * uncontrolled infection or inflammation
   * uncontrolled psychiatric disorder or central neurologic disease
   * not fully recovered from previous surgery
   * prior anticancer therapy (chemotherapy, immunotherapy, radiation) within 6 months
   * intolerable to oral administration or a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome
   * fertile males and females who are unwilling to use effective contraceptive methods.
   * pregnancy, breast feeding or intention to become pregnant
   * interstitial pneumonia or pulmonary fibrosis
   * peripheral neuropathy with functional impairment
   * hypersensitivity to paclitaxel, oxaliplatin, capecitabine, fluoropyrimidine or Cremophor EL.
   * concomitant therapy with any substrate or inhibitor of Cytochrome P450 2C8 or 3A4
   * concomitant therapy with sorivudine or brivudine
   * Dihydropyrimidine dehydrogenase (DPD) deficiency.
   * current or recent (within the 7 days prior to enrollment) treatment of tegafur-gimeracil-oteracil potassium
Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation

The purpose of this study is to collect device and procedure experience in everyday clinical practice. The patients are being asked to participate in this study because they are a surgical candidate for the treatment of a broken shoulder and are considering treatment with the PH Cage device.

The Conventus CAGE™ PH (PH Cage) System Post-Approval Prospective Study (Study) is a multi-center, prospective, post-approval clinical study designed to collect device and procedure experience in everyday clinical practice.

Specifically, the study will provide:

1. Device safety and patient outcome data.
2. Device usage data.
3. Performance data for the implant procedure.
4. Publications.
5. Early economic benefit data.

Patient Assessments Demographic and general health data will be collected on all patients at the baseline appointment to ensure subjects meet inclusion/exclusion criteria. In addition, to these data, x-rays and adverse event reports related to the implanted device, surgical procedure and/or study data collection methods will be collected.

Patients will be seen at baseline, 2-, 6- and 12-week, 1- and 2-year post op.

Patient participation in this study is voluntary. However, post-implant patient follow-up adds to the medical community's understanding of proximal humerus fracture patient outcomes, as well as the safety and performance of the PH Cage.

Eligibility Criteria:
Inclusion Criteria:

The following criteria, in accordance with the product labelling (Instructions For Use), should be considered when selecting patients for inclusion in this Study:

* Patient must be of at least legal age of consent according to applicable State Law.
* Patient is able to understand and provide written consent.
* Patient is willing and able to cooperate with post-operative instructions, including follow-up examinations and limitations of strenuous activities involving the injured extremity.

Exclusion Criteria:

* The PH Cage should not be implanted in patients with suspected or known allergies to titanium or nickel.
* Patients with open wound fractures.
* Patients with ipsilateral injures or concomitant operation(s) that will have a material impact on the study. Such injuries/ operations are those that affect general health status or the function of the injured extremity.
* Pregnant patients.
* Patients with current or history of mental illness and/or dementia.
* Patients with current or history of alcoholism and/or chemical substance abuse.
* Patient has a medical condition(s) that precludes cooperation with the rehabilitation regimen.
* Patient has active infection at the operative site or other active systemic infection.
* Patient has a pathologic proximal humerus fracture.
* Patients proximal humerus fracture extends into the diaphysis.
* Patient has associated glenohumeral dislocation.
* Patient has ipsilateral injury or concomitant surgery that will have a material impact on the study, such that the injury/surgery affects the patients' health status or the function of the injured extremity.
Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention

Stroke-like migraine attacks after radiation therapy-also known as SMART syndrome-constitute a rare condition typically characterized by headache, seizures, vision abnormalities, hemiparesis, and aphasia. The condition usually resolves within a few days or weeks of onset with no residual impairments. However, resolution in some cases extends over a period of months rather than weeks and may be incomplete. The purpose of this case report is to provide an in-depth description of the progression of changes in cognitive and language functioning for a person exhibiting SMART syndrome characterized by slow recovery.


Eligibility Criteria:
Inclusion Criteria:

* exhibit cognitive and language deficits secondary to SMART syndrome
* be a former or current client of Quality Living, Inc., Omaha, Nebraska
* be a native speaker of English

Exclusion Criteria:

-
EMG Biofeedback Training to Improve Balance in Individuals with Multiple Sclerosis

The goal of this clinical trial is to test the impact of a novel dual-task EMG Biofeedback training method for improving balance in individuals living with multiple sclerosis. The main question\[s\] it aims to answer are:

* Does dual-task EMG biofeedback training deliver lasting balance benefits up to 3 months following the intervention?
* Are the benefits greater than those for participation in traditional balance training exercises?
* Do the benefits vary with the severity of disability?

Participants will receive either EMG Biofeedback (EMG-BF) training or traditional balance exercise (BAL-EX) training. Both treatments involve three 30-minute sessions of the training every week for 6 weeks (18 sessions). During the sessions, participants in the EMG-BF treatment group will perform targeted exercises using feedback from adhesive (sticker) sensors on their arms and legs. Participants in the BAL-EX treatment group will following an instructor through balance training movements that are traditionally prescribed by physiotherapists to improve balance. Measurements will be taken at the beginning of the study, after six weeks of training, and three months after the end of training.

Researchers will compare the groups to see if balance and related outcomes are improved more by 6-weeks of EMG-BF training than BAL-EX.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-80 years with a formal diagnosis of MS.
* Participants must be ambulatory and report problems with walking and/or balance.
* Have stable disease with no relapses in the last 3 months.
* Agreement to not introduce or change the dosage of pharmaceutical treatments during the study period. This includes intramuscular injections (e.g., Botox), intravenous, and orally administered drugs.
* Agreement to maintain the frequency, duration and intensity of physical therapy or any alternate therapies (e.g., massage, osteopathic, chiropractic, etc.) for the duration of the trial.

Exclusion Criteria:

* Unable to follow instructions due to cognitive deficit or language barrier
* Presence of visual disorders that prevent meaningful interaction with the intervention interface.
* Unable to maintain stable pharmaceutical treatment for the duration of the study.
* Unable to maintain the frequency, duration and intensity of physical therapy or alternate therapies outside of the trial for the duration of the trial.
* Received Botox treatment within 3 months of the onset of the study.
Artificial Intelligence Self Harm Application

This is a mixed-methods study. The quantitative component will comprise of a multicentre rater-blind, randomized controlled trial to evaluate the feasibility and acceptability of AISHA in addition to treatment as usual (TAU) compared to TAU alone in Pakistan.

In-depth interviews and focus groups with other stakeholders will take place to consider the wider implementation of AISHA in mental health services in Pakistan.

Mental health resources in LMICs, including Pakistan, do not match the burden of mental illness, resulting in a massive mental health treatment gap. Interventions delivered on mobile platforms (M-Health) have the potential to overcome these barriers. Evidence supports the acceptability and efficacy of interventions delivered on digital platforms for a variety of mental disorders. Mobile-based interventions have been developed to target self-harm, however, there is paucity of research supporting their efficacy in LMIC.

To our knowledge there are currently no clinical trials examining the feasibility, acceptability and preliminary efficacy of a culturally adapted CBT informed problem solving intervention delivered on a digital platform for self-harm prevention.We have developed an Artificial Intelligence Self-Harm prevention Application (AISHA) to deliver an evidence-based problem solving intervention (CMAP) for people presenting with self-harm.

Eligibility Criteria:
Inclusion Criteria:

* All patients presented to the participating family physicians, community health centres, emergency departments or admitted to a general hospital after an episode of self-harm at participating sites.
* Age 16 to 25 years
* Participants must be familiar with functioning of handheld mobile devices (mobile phones, tablets).
* Able to read Urdu or English language.
* Individuals able to provide written informed consent.
* Have an android mobile phone/device

Exclusion Criteria:

* Participants with ICD-I0 mental disorder; due to a general medical condition or substance misuse, dementia, delirium, alcohol or drug dependence, schizophrenia, bipolar disorder, learning disability which prevents participation.
* Participants needing inpatient psychiatric treatment as determined by their clinical teams
Protocol for the Evaluation of Dario™ BGMS Performance at Elevated Altitude

The purpose of this study is to assess the performance of the Dario Blood Glucose Monitor (BGMS), at elevated altitudes, by obtaining whole blood fingerstick samples from individuals and analyzing the blood on the Dario Blood Glucose Monitor (BGMS) and comparing the readings to readings obtained from the YSI 2300 STAT Plus glucose analyzer.

The study will be performed with 50 fresh capillary blood samples, collected by fingerstick using Dario single use lancet. Additional fingerstick with dedicated disposable lancets will be used to collect sufficient capillary fresh blood to be analyzed by the YSI 2300 STAT Plus analyzer. Additional fingersticks may be necessary if volume of blood from first fingerstick is insufficient.

Eligibility Criteria:
Inclusion Criteria:

* Age of subject is 18 years or older
* Able to speak and read English

Exclusion Criteria:

* Pregnant
* Has any condition that the principal investigator believes may interfere in the subject's participation in the trial.
Treatment and Vaccine Development of Mycoplasma Pneumoniae

A randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline for pediatric Mycoplasma pneumonia.

Mycoplasma pneumoniae accounts for 10-30% of community-acquired pneumonia (CAP) in children. Proportionally, M. pneumoniae has become the most important pathogen for childhood pneumonia after the widespread use of Streptococcus pneumoniae vaccines. M. pneumoniae is routinely treated with antibiotics, and the macrolides antibiotics are the drug of choice for M. pneumonia infection. However, macrolide-resistance rates have increased to 20 and 100% in Asia. In previous studies, the most common mutation point, A2063G, was detected from 23% of local strains in Taiwan. The evolution and spreading of Mycoplasma in Taiwan and different countries are unknown. While the macrolide-resistance is increasing, the optimal therapy remains unclear. Both tetracyclines and fluoroquinolones showed promises in treating macrolide-resistant M. pneumoniae in adults. However, their use in children is not recommended due to safety concerns. Recently, evidence are accumulating that doxycycline, unlike other tetracyclines, does not cause staining of teeth. In the current study, the investigators are going to carry out a randomized control trial to compare the efficacy and safety of doxycycline against macrolide-resistant M. pneumoniae.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-18 years, admitted due to lower respiratory tract infections. Mycoplamsa pneumonia is diagnosed.
* The diagnosis is made within 72 hours after fever onset.
* The patient and his/her guardians are willing to participate the study and able to follow the instruction.

Exclusion Criteria:

* None