cyrilzakka/clinical-trials huggingface dataset:
Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke

On the basis that the combined use of Uni-TENS and TRT is an effective intervention in upper limb recovery, and the advantage of Bi-TENS eliciting extra neural pathway in the intact hemisphere to facilitate the motor recovery, There is a research gap in whether the Bi-TENS over both the paretic and non-paretic limbs could probably augment the treatment effects of TOT in upper limb motor control in people with stroke.

The purpose of this study is to determine whether Bi-TENS+TOT was superior to Uni-TENS+TOT, Placebo-TENS+TOT alone and no active treatment in improving the upper limb motor control and upper limb function and community integration in people with chronic stroke.

The null hypothesis will be that Bi-TENS+TOT is not significantly different from Uni-TENS+TOT,Placebo-TENS+TOT alone and no active treatment in improving the upper limb motor control and upper limb function and community integration in people with chronic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be recruited from local self-help groups through poster advertising.
* Subjects will be included if they are between 50 and 80 years of age
* Have been diagnosed with ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography within the previous 1 to 10 years
* have volitional control of the non-paretic arm and at least minimal antigravity movement in the shoulder of the paretic arm,
* have at least 5º in wrist extension in the antigravity position,
* score \> 6 out of 10 in the Abbreviated Mental Test, and
* are able to follow instructions and give informed consent.

Exclusion Criteria:

* • have any additional medical, cardiovascular or orthopedic condition

  * use a cardiac pacemaker
  * have receptive dysphasia
  * have a significant upper limb peripheral neuropathy
  * are involved in drug studies or other clinical trials, or
  * have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm, and
  * have a skin allergy that would prevent electrical stimulation.
Impact of an Integrated Obesity Management System on Patient's Care

The investigators developed a program aimed at enhancing primary care physician (PCP) teams' expertise, self-efficacy and attitudes with respect to obesity management. The investigators implemented and evaluated this obesity management system based on a preceptorship combined with a virtual learning community favouring continuous support of family medicine groups (FMGs, Groupes de Médecine Familiale) by a team of experts in obesity management; significant improvements regarding their attitudes and perception of self-efficacy were observed immediately after the preceptorship and maintained after one year. Furthermore, the investigators observed significant changes in their practice that were maintained one year later.

The investigators hypothesize that their program combining preceptorships with a virtual community will improve: (1) management and weight loss of obese/overweight subjects who are treated by PCPs for hypertension (HTN), type 2 diabetes (DM2) or impaired glucose tolerance (IGT); and (2) screening and initial management of obesity among unselected patients of PCPs who practice in FMGs.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have, during the past 2 years, at least 4 documented visits for the targeted diseases group and at least 2 visits for the regular follow-up group

Exclusion Criteria:

* Active mental health problem
* Active psychiatric disorder
* Cancer in the last five years
* Patient with medication that changed in the last 6 months
Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis

This is a prospective, randomized, single-blinded,multi-center trial to compare the efficacy of an Estrogen-intrauterine stent system with foley balloon combined with intrauterine cross-linked sodium hyaluronate gel in the prevention of intrauterine adhsion recurrence after hysteroscopic adhesiolysis.

Patients suspect to be suffering from IUA will be recruited following a systematic pre-operative assessment process. This will include a detailed history of the menstrual pattern, previous intrauterine surgery, and reproductive history, as well as 3D transvaginal ultrasound. The severity and extent of intrauterine adhesions will be scored according to the AFS score. All patients will receive hysteroscopic adhesiolysis with the aid of ultrasound guidance as necessary. After adhesiolyis, the patients will assigned to two groups randomly,namely,the E-IUS(estrogen intrauterine stent system) group and the control group. Adhesion will be evaluated by hysteroscopy at second-look hysteroscopy before 60 after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 18-40 years;

  * Meets the diagnostic criteria for moderate to severe uterine adhesions;

    * Has the indication for TCRA surgery and is intending to undergo TCRA surgery;

      * Female subjects are not breastfeeding at the time of the screening visit; ⑤ Voluntary acceptance of the treatment and has signed the informed consent form.

Exclusion Criteria:

* Known allergic reactions to or contraindications for silicone rubber materials, estradiol and its metabolites, Foley balloon catheters and/or intrauterine cross-linked sodium hyaluronate gel;

  * Presence of contraindications for TCRA surgery;

    * Requires oral hormonal medications for a prolonged period of time;

      * Has used high-dose estrogen medication within one month prior to surgery;

        * Suffering from diseases such as genital tract tuberculosis, acute genital tract inflammation, pelvic inflammatory disease, abnormal uterine bleeding caused by systemic disease or malignant tumours of the genital organs; ⑥ Perimenopausal and menopausal females;

          ⑦ Comorbid with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal or hematopoietic system, or peptic ulcer disease, or severe diseases affecting patient survival (such as tumours or AIDS), or mental illness;

          ⑧ Drug or alcohol dependence;

          ⑨ Has enrolled in other clinical trials within the last 1 month;

          ⑩ Patients with factors considered by the investigators to be unsuitable for enrollment.
The Effect of NN1250 in Subjects With Type 2 Diabetes of Different Race and/or Ethnic Origin

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the pharmacodynamic (effect) and pharmacokinetic (exposure of drug) properties of NN1250 (insulin degludec, IDeg) in subjects with type 2 diabetes of different race and/or ethnicity.


Eligibility Criteria:
Inclusion Criteria:

* Either - Black or African American not of Hispanic or Latino origin or - White of Hispanic or Latino origin or - White not of Hispanic or Latino origin
* Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Treated with insulin for at least 3 months, alone or in combination with maximum 2 oral antidiabetic drugs (OADs)
* Body mass index maximum 40.0 kg/m\^2

Exclusion Criteria:

* Use of GLP-1 receptor agonists (exenatide, liraglutide), thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors within 3 months prior to screening
* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Efficiency of Budesonide Combined With Formoterol and Tiotropium in the Treatment of Acute Exacerbation of ACO

This study evaluates the efficiency of ICS(budesonide) combined with LABA (formoterol) and LAMA(tiotropium) in the treatment of acute exacerbation of asthma-chronic obstructive pulmonary overlap. Half of participants will receive budesonide,formoterol and tiotropium in combination, while the other half will receive budesonide and formoterol only.

ACO(asthma-chronic obstructive pulmonary overlap) is a relatively new proposed clinical form of chronic airway disease. Guideline or preferring therapy for ACO is still evolving. Current clinical solution is when ACO presents like asthma, initial treatment will accord to the guideline for asthma , while it presents like COPD, COPD recommendation treatment (not alone ICS,but ICS in addition of LABA with or without LAMA) will be chosen, which are subjective. Although present guidelines has recommended that ACO should be treated with at last two inhalant, but limited date have proven it.

A random controlled trial will be conducted to evaluate the efficiency of ICS(budesonide) combined with LABA (formoterol) and LAMA(tiotropium bromide) in the treatment of acute exacerbation of ACO,compared with the control group receiving tiotropium bromide with formoterol only.

Eligibility Criteria:
Inclusion Criteria:

* subject has ACO

Exclusion Criteria:

* acute exacerbation of ACO;
* acute infection;
* postbrochodilator FEV1/FVC\> 0.7;
* pulmonary complications: bronchiectasis, active tuberculosis, pulmonary fungal disease or lung cancer
* history of other malignant tumor
* with rheumatic diseases;
* with some serious heart, cerebrovascular, liver, kidney or hematopoietic system diseases
* with tachyarrhythmias；
* mental patients;
* with moderate to severe renal insufficiency (creatinine clearance ≤ 50ml / h)
* allergic to the budesonide, formoterol or tiotropium bromide;
* history of acute gastrointestinal bleeding within 3 months;
* with severe angle closure glaucoma patients;
* pregnancy,lactation;
* have participated in other clinical trials in 3 months；
* hospital staff and their relatives
Efficacy and Safety of EsoDuo®

Clinical Trial to Evaluate the Effects of EsoDuo® in Controlling Reflux Symptoms Related to the Acid

The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study \[RACER Study\]

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female aged ≥ 19 years
2. Patients diagnosed with non-erosive reflux disease or mild erosive reflux disease
3. Episode of heartburn the GERD symptom(either heartburn or gastric acid reflux)

Exclusion Criteria:

1. Surgery history on stomach or esophagus
2. Barrett's esophagus (over 3cm), esophageal varices, esophageal stricture, esophageal achalasia, eosinophilic esophagitis, and primary motility disorders
3. Patients diagnosed with Grade C or Grade D according to the LA Classification system during upper gastrointestinal endoscopy
4. Patients with a history of malignancy within the past 5 years prior to the screening visit (Visit 1)
5. Patients who have taken prohibited concomitant medications within 14 days prior to the screening visit or require continuous administration of prohibited medications during the trial period.
6. Clinically significant Abnormal Lab test
7. Pregnant woman, Breastfeeding woman.
Neural Glide Technique on the Sciatic Nerve and the Passive Stretching Technique in the Short Hamstring Muscles

The project consists of studying the differences between neural gliding techniques of the sciatic nerve and passive stretching of the hamstring muscles in football players.

Study of hamstring shortening in football players through passive muscle stretching and the use of the neurodynamic technique of longitudinal sliding of the sciatic nerve.

Eligibility Criteria:
Inclusion criteria:

* Footballers with shortening of the hamstring musculature.
* Age between 16 and 18 years.
* Subjects who agree to participate in the study.

Exclusion criteria:

* Subjects with significant nerve involvement.
* Subjects with scars or wounds affecting the assessment.
* Subjects with muscle injuries in the lower limb.
* Subjects with herniated discs or chronic acute low back pain.
* Subjects with pain or paresthesia in the lower limbs.
Results of a Program of Newborn Hearing Screening (NHS) in Cuiaba-Brazil

The study aims to demonstrate the indices of quality of a Newborn Hearing Screening (NHS).

The data refer to infants underwent newborn hearing screening by evoked otoacoustic emissions by transient stimulation, using the analyzer EOA Biologic. Examinations archived in the computer's service were analyzed for the amount of infants who passed or failed the screening, as well as the correlations with the same age and gender.

Eligibility Criteria:
Inclusion Criteria:

* middle ear conditions integrates

Exclusion Criteria:

* middle ear conditions inadequate
A Retrospective Study of the Relationship Between White Matter Hyperintensities(WMHs) Within the Cholinergic Pathways and the Cognition of PD Patients After Bilateral STN DBS

To retrospectively investigate the relationship between the Cholinergic Pathways Hyperintensities Scale (CHIPS) score and the change of cognitive status of Parkinson's disease (PD) patients after bilateral subthalamic nucleus deep brain stimulation (STN DBS).

In this observational study, we will retrospectively analyze 38 PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University during the year of 2008-2012. All patients will be evaluated by Unified Parkinson's Disease Rating Scale part III(UPDRSIII) before and after operation. Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment(MoCA) in the on medication condition pre-operation and on stimulation on medication condition post-operation. The follow-up time points are one week pre-operation and 6, 12, 24 months post-operation. Before operation, white matter hyperintensities（WMHs）in the cholinergic pathways will be determined on a 3.0 Tesla MRI, using the visual rating scale of Cholinergic Pathways Hyperintensities Scale (CHIPS). A correlation analysis will be conducted to investigate the relationship between CHIPS score and the change of cognitive status of PD patients after bilateral STN DBS retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease according to United Kingdom Parkinson's Disease Brain Bank Criteria
* Experience bilateral STN DBS surgery in the First Affiliated Hospital, Sun Yat-sen University, China.
* Preoperative 3.0 Tesla MRI scanning.

Exclusion Criteria:

* Loss to follow-up
* Participation in other clinical trials
Resistive Co-contraction Training After Anterior Cruciate Ligament Reconstruction

This study investigates different resistive co-contraction trainings effect on knee strength recovery after ACL reconstruction. Participants will be divided into three groups. Group 1 will receive standard ACL rehabilitation with 8 week co-contraction training in open kinetic chain position, Group 2 will receive standard ACL rehabilitation with 8 week co-contraction training in open kinetic chain position and Group 3 (control group) will only receive standard ACL rehabilitation.

Co-contraction trainings can enhance joint stability via improving proprioceptive ability and stimulates muscle activity after injury and/or surgery. The participants will be assigned to the different groups one month after surgery. They will receive 8-week-treatment. Isometric strength of quadriceps and hamstring muscles will be measured at first,third and sixth months after surgery. Concentric and eccentric strength of quadriceps and hamstring muscles will be measured only at sixth months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* ACL reconstruction with hamstring autograft
* starting PT program within one week after surgery

Exclusion Criteria:

* Revision surgery
* serious cartilage damage and/or cartilage repair
* ACL reconstruction with allograft and patellar tendon graft
* Having systemic and/or neurological problems
Bowel Prep vs Non-Bowel Prep for Laparoscopic Colorectal Surgery

Research Question: Are anastomotic leak and surgical site infection rates equivalent in patients having laparoscopic bowel resections without bowel preparation vs those having bowel preparation?

Bowel preparation is a distressing and uncomfortable procedure for patients undergoing laparoscopic colorectal surgery, and also carries some risk of morbidity due to dehydration, electrolyte inbalance and possible infectious complications. If it is found that there is no difference between those patients who have preoperative bowel preps and those who do not have them, then we can save these patients this additional distress and risk at the time of their surgery.

Rationale: The question of whether a bowel prep is needed for colon resection in open surgery has been answered. However, in laparoscopic colorectal resections, it has not been prospectively investigated. Usually, reasons for still using a bowel prep in laparoscopic colon resections is that small instruments grasping the colon can tear it, and without a prep, stool spillage can result. As well, it may be difficult to manipulate a colon filled with stool, and difficult to identify lesions to be resected.

There are no previous randomized trials in the laparoscopic literature comparing laparoscopic colorectal resections with and without bowel preparations. There are a number of trials for open resections and one trial including both laparoscopic and open resections. Unfortunately this trial does not separate the data analysis for these two groups.

Primary and Secondary Outcomes: The question to be identified is whether anastomotic leaks, and surgical site infection rates are equivalent in patients having laparoscopic resections without bowel prep versus prepped patients.

Methodology: Once consent is obtained, the patients will be randomized into two groups-the study group who will eat a low residue diet prior to surgery and who will not undergo bowel preparation, or the control group who will complete the standard bowel preparation protocol. Both groups will have the scheduled surgery. All patients will be monitored for signs of anastomotic leak and surgical wound infection daily while in hospital and at routine follow up visits at 2 and 6 weeks postoperative. If these two complications are observed, standard treatment will be followed.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective laparoscopic colorectal resection for benign or malignant disease
* adults aged 18-85 years
* ASA 1-3

Exclusion Criteria:

* contraindications to laparoscopic surgery
* patients undergoing procedures that result in creation of a stoma or ileostomy or loop ileostomy
* patients with pre-operative perforation of established infection
* patients who cannot understand the directions for bowel preparation or low residue diet
* patients with GI obstructions
* patients who will not be able to attend the followup appointments
Efficacy of Pea Hull Fiber - Phase 2

The purpose of this randomized, cross-over study is to explore the effects of pea hull fiber on bowel movement frequency, transit time, appetite, gastrointestinal symptoms, microbiota composition and activity.

An 8-week randomized, cross-over study will be carried out to assess the efficacy of pea hull fiber. Participants will complete a 2-week baseline period during which appetite, stool frequency, and stool consistency (transit time) will be collected by an online questionnaire, and participants will collect a single stool. Dietary data (Automated Self-Administered 24-Hour diet recall) will be obtained at baseline and at each study visit. Participants will be randomized on or about day 15 and consume snacks without pea hull fiber for a 2-week control period, and snacks with added pea hull fiber for a 2-week treatment period separated by a 2-week washout period. In both intervention periods, participants will complete daily questionnaires to assess stool frequency and consistency (transit time). An online questionnaire assessing appetite will be administered once per week. The GSRS will be competed at each study visit. During washout periods, the same data will be collected as will be done during the baseline and intervention periods. Participants will be asked to collect one stool during baseline and during weeks 4, 6, and 8 for a total of 4 stools. Stool samples will be analyzed for changes in the microbiota.

Eligibility Criteria:
Inclusion criteria:

* Are willing to have height and weight measured and provide demographic information (e.g. age, race, sex).
* Children age between 8-15 years old.
* Are occasionally constipated.
* Are willing to consume pea hull fiber and control snacks daily each for a 2-week period
* Are willing to complete a daily questionnaire throughout the entire 8-week study.
* Are willing to complete the appetite questionnaire two times per week.
* Are willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) bi-weekly.
* Are willing to be interviewed for Automated Self-Administered 24-Hour-Kids-2014 (ASA24-Kids-2014) one time per 2-week period throughout the study.
* Are willing and be able to provide a valid social security for study payment purposes.

Exclusion criteria:

* Have any known food allergies.
* Are currently taking medications for diarrhea.
* Have taken antibiotics within the past four weeks prior to randomization.
* Have ≥ 6 bowel movements per week
* Are currently taking probiotics supplements and do not want to discontinue a minimum of two weeks prior to the study.
* Have previously or are currently being treated for any gastrointestinal diseases such as (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).
Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers

This study will test single doses of the study drug in increasing amounts to see if it is safe.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
* Subject has a body mass index of 18.5 to 32 kg/m2, inclusive.

Exclusion Criteria:

* Subject is a woman who is of childbearing potential or is breastfeeding.
* Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma

The primary objective of the study is to determine the safety profile and overall response rate of IPI 504 in patients with advanced dedifferentiated liposarcoma.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at the time of signing informed consent.
* Histologic diagnosis of dedifferentiated liposarcoma.
* Available archival pathology specimen or tissue sample from a new biopsy for confirmation of diagnosis by central pathology reading.
* At least one prior chemotherapy regimen for dedifferentiated liposarcoma.
* No more than 2 prior chemotherapy regimens for dedifferentiated liposarcoma. Note: Any number of non-chemotherapy regimens is permitted.
* Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST (version 1.1) with at least one measurable lesion.
* Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
* Life expectancy ≥6 months.

Exclusion Criteria:

* Prior treatment with any heat shock protein 90 (Hsp90) inhibitor.
* Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease
* Patients with prior hepatic resections or hepatic-directed therapy
* Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to dosing.