cyrilzakka/clinical-trials huggingface dataset:
Upper Limb Mirror Therapy with Bilateral Transcutaneous Electrical Nerve Stimulation to Improve Upper Limb Functions in Patients with Stroke

This study compare the effectiveness of 2 rehabilitation programmes that use (1) MT with Bilateral TENS (Bi-TENS), (2) sham-MT with Bi-TENS (Bi-TENS), respectively, in addition to conventional rehabilitation of standardized upper limb training, in improving upper limb motor functions, activities of daily living, community integration, and quality of life in patients with stroke.

The principal aim of the proposed study will be to demonstrate whether MT with Bi-TENS is more effective than sham-MT with Bi-TENS in improving upper limb motor functions, activities of daily living, community integration and quality of life in patients with stroke.

The null hypothesis will be that MT with Bi-TENS is not significantly different from sham-MT with Bi-TENS in improving upper limb motor functions, activities of daily living, community integration, and quality of life in patients with stroke.

Eligibility Criteria:
Inclusion Criteria:

1. have been diagnosed with ischemic brain injury or intracerebral hemorrhage by MRI or computed tomography within three weeks to 10 years after the first onset of stroke;
2. have volitional control of the non-paretic arm, and at least minimal antigravity movement in the shoulder of the paretic arm;
3. have at least 5 degrees in wrist extension of the paretic arm in the antigravity position
4. are able to score \> 6 of 10 of abbreviated Mental Test;
5. are able to follow instruction and give informed consent of the study.

Exclusion Criteria:

1. Have any additional medical, cardiovascular and orthopedic condition that would hinder the proper assessment and treatment;
2. Use cardiac pacemakers;
3. Have receptive dysphasia;
4. Have a significant upper limb peripheral neuropathy (e.g., diabetic polyneuropathy);
5. Have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm;
6. Have skin allergy that would prevent electrical stimulation;
7. Are involved in drug studies or other clinical trials.
Early Recognition and Dynamic Risk Warning System of Multiple Organ Dysfunction Syndrome Caused by Sepsis

Background Sepsis still the main challenge of ICU patients, because of its high morbidity and mortality. The proportion of sepsis, severe sepsis, and septic shock in china were 3.10%, 43.6%, and 53.3% with a 2.78%, 17.69%, and 51.94%, of 90-day mortality, respectively.

Besides, according to the latest definition of sepsis- "a life-threatening organ dysfunction caused by a dysregulated host response to infection. ", it is a disease with intrinsic heterogeneity. Sepsis as a syndrome with such great heterogeneity, there will be significant differences in the severity of sepsis. As a result, there will be significant differences in the treatment and monitoring intensity required by patients with severe sepsis and mild sepsis. No matter from the economic perspective or from the risk of treatment, a proper level of treatment will be the best chose of patient. However, the evaluation of the sepsis severity was not satisfied. Such of SOFA, the AUC of predict patients' mortality was only 69%. Weather these patients occurred multiple organ dysfunction syndrome (MODS) may had totally different outcome and needed totally different treatment. All these treatments need early interference, in order to achieve a good prognosis. Hence, early recognition of MODS caused by sepsis became an imperious demand.

Study design On the base of regional critical medicine clinical information platform, a multi-center, sepsis big data platform (including clinical information database and biological sample database) and a long-term follow-up database will be established. Thereafter, an early identification, risk classification and dynamic early warning system of sepsis induced MODS will be established. This system was based on the real-time dynamic vital signs and clinical information, combined with biomarker and multi-omics information. And this system was evaluated sepsis patients via artificial intelligence, machine learning, bioinformatics analysis techniques.

Finally, optimize the early diagnosis of sepsis induced MODS, standardized the treatment strategy, reduce the morbidity and mortality of MODS through this system.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with sepsis3.0

Exclusion Criteria:

* Patients' data missing is greater than 20%
Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section

The cesarean section is one of the most commonly performed surgeries in the world and it represents 20% of the births in France. Postoperative pain is moderate-to-severe during the first 48 hours after this procedure. Thereby its control is prominent for the medical team in order to shorten the duration of hospital stay as well as to permit an early return to daily activities for these surgical patients.

Pain control after cesarean section is usually based on non-opioids and epidural administration of morphine if an epidural catheter has been previously placed for the procedure. However epidural morphine is associated with a number of side effects. Wound infiltration with local anesthetics has been widely used in the multimodal management of postoperative pain and it may reduce postoperative morphine consumption.

In patients enrolled for emergency cesarean delivery with epidural catheter, the objective of this study will be to compare the analgesia provided by a local anesthetic wound 48-hours infusion through a multiorifice catheter (ropivacaine 2 mg/mL) versus epidural analgesia (epidural morphine bolus). Quality of pain control will be assessed with the measurements of morphine consumption and pain scores at rest and during mobilisation over 48 hours. At 3 months, patients will be interviewed to assess their residual pain and their satisfaction.

It is hypothesized that local anesthetic wound infusion would be non-inferior than epidural morphine analgesia to control pain after cesarean section, and be associated with a reduction of side effects related to the analgesics.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age 18 years
* ASA-1 and 2 Parturient
* Emergency Cesarean delivery under epidural anesthesia
* Suprapubic incision used for cesarean section
* Functional epidural Catheter before the cesarean decision

(ASA Scores : Physical Status score)

Exclusion Criteria:

* ASA-3 and 4 Parturient
* BMI \> 35 (before pregnancy)
* Existing chronic pain
* Contra-indication to study treatments
* Chronic use of analgesics or morphinic
* Preeclampsia
* Infection
* \< 37 weeks pregnant +/- 3 days
Tooth Borne Versus Temporary Anchorage Devices (TAD) Based Intrusion Systems for the Correction of Anterior Deep Overbite

Compare the tooth borne versus fixed orthodontic intrusive system (TADs) for the correction of anterior deep overbite

this study determined which method was more compliant, efficacy and comfortable. It was performed to evaluate intrusion of upper incisors with applying tooth borne system as Connecticut Intrusion Arch (CIA) and temporary anchorage devices (TADs) \[miniscrew\] and evaluate the dental and skeletal cephalometric effects of these intrusion methods on individuals with deep bite caused by supraocclusion of upper incisors. It also evaluated oral hygiene and pain sensation in the two groups during the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Class I or Class II malocclusion with minimal crowding.
2. 70% to 100% overbite.
3. High lip line with gingival display on smiling and super-eruption of maxillary incisors.
4. All patients had permanent dentition with average to vertical growth pattern and curve of Spee of 4mm or less.

Exclusion Criteria:

1. Having missing teeth on the anterior maxillary area.
2. Any history of trauma or root canal treatment.
3. Previous orthodontic treatment.
4. Low lip line duing social smile.
5. Having any hormonal disorder or syndromes.
Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)

The purpose of the study is to to assess the effect of multiple oral doses of ZD4054 (Zibotentan) on the pharmacokinetics of a CYP450 3A Probe (midazolam) in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Normal resting ECG with QTcB interval \<450ms

Exclusion Criteria:

* Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
* Healthy volunteer has a known hypersensitivity to midazolam or any of the excipients of the midazolam tablet
* Medical diagnosis of migraine with an attack during the 12 months prior to Screening
Study to Understand Clinical Characteristics, Treatment Pathway in Chronic Lymphocytic Leukemia

A Multicenter Retrospective Study to understand the clinical characteristics, treatment pathway and resource utilization for patients with chronic lymphocytic leukemia A retrospective, multi-centre, observational study to describe disease characteristics, treatment patterns, treatment-related outcomes, and resource utilization for Chronic Lymphocytic Leukemia (CLL) patients in multiple international regions

CREEK is a retrospective, observational, registry-based study including patients with an incidental diagnosis of CLL and started treatment (1st line, 2nd line, or Subsequent lines of treatment) within the period between 01 June 2016 and 12 months before data collection as identified from the patient records (from participating hospitals across the GCC States and the International region countries) with at least 12 months of follow-up, after starting on treatment.

Moreover, the study will include a pilot cohort in the GCC as an exploratory objective to describe the clinical and patient characteristics for the treatment-naive CLL patient

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Chronic Lymphocytic Leukemia (CLL)
* Initiated CLL treatment (including 1st line, 2nd line, or Subsequent lines of treatment) within the period between 01 June 2016, and 12 months before data collection

  - For GCC pilot cohort patients: treatment-naive CLL patients diagnosed between 01 June 2016, and 12 months before data collection.
* Available medical records at the participating site reflecting at least 12 months of follow-up after starting on treatment (except in the case of the participant death within one year following treatment initiation).
* Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver was granted), according to local regulations.
* Adult male or female ≥18 years old at the time of diagnosis or according to the age of majority as defined by local regulations).

Exclusion Criteria:

* Failure to meet one or more of the inclusion criteria.
* Any diagnosis of B-cell malignancies other than CLL.
* Current or prior use of "acalabrutinib" treatment.
* Currently/previously receiving treatment in an interventional clinical trial at the time of entry into this study for indications CLL.
Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting

The goal of this randomized controlled study is to assess the effect of guided imagery on chemotherapy-related nausea and vomiting in pediatric oncology patients.

Participants will receive either guided imagery+routine care or routine care. The researchers will compare nausea and vomiting and vital signs between groups.

Despite significant advances in anti-emetic treatment, chemotherapy induced nausea and vomiting (CINV) is considered a major side-effect that significantly reduces the quality of life of children diagnosed with cancer. Guided imagery is one of the methods of distraction that allows the individual to go to an environment or scene that will make the individual comfortable, peaceful, happy, and focused. In this study, the participants will be randomized in a single blind manner (participant) to either intervention or control groups.

Eligibility Criteria:
Inclusion Criteria:

* 7 to 18 years old,
* who will receive intravenous chemotherapy,
* no cognitive or neurological disease that would prevent communication,
* receiving a chemotherapy protocol with a high or moderate emetogenic effect according to the MASCC/ESMO Antiemetic Guideline Classification,
* no verbal, visual and auditory communication disabilities (ability to speak Turkish, no mental deficiency),
* children whose parents and themselves volunteered to participate in the study

Exclusion Criteria:

* Children receiving radiotherapy,
* taking ginger powder or vitamins to reduce nausea,
* children who did not want to participate in the study
Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy

In minimally sedated Asian patients in a community setting the investigators showed that a limited volume of water infusion instead of air insufflation in either the rectal sigmoid colon or the whole colon significantly reduced pain score during colonoscopy. Cecal intubation rate was not compromised. The reduction of pain score ranges from 25% to 32 % in our previous studies.1, 2 In contrast, several US reports described the successful use larger volumes of water infused throughout the entire colon in patients undergoing colonoscopy which result in a greater reduction of the pain score, averaging about 56%.3-5 A recent review suggested that the cause of the difference might lies in the timing of water removal.6 Specifically, the investigators group removed the infused water predominantly during withdrawal phase (water immersion) and the U.S. group removed water during insertion phase (water exchange).

This prospective, randomized controlled trial compared water exchange or water immersion with traditional air insufflation in patients undergoing minimally sedated colonoscopy. The investigators test the hypothesis that water exchange can reduce more pain than water immersion in the investigators clinical setting.

All procedures will be recorded and stored as digital files.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing minimally sedated colonoscopy

Exclusion Criteria:

* Obstructive lesions of the colon, inadequate bowel preparation, allergy to meperidine, massive ascites, past history of partial colectomy, or refusal to provide written informed consent.
Em-power: Maximizing Functional Independence for Children with Severe Cerebral Palsy

For children with severe cerebral palsy, a powered wheelchair (PWC) may provide their only option for functional mobility and independence. PWC use is often restricted to a small percentage of children who can quickly demonstrate proficient PWC skills within a single 30-minute PWC trial. This 2-arm, parallel group, single blinded, pre-test-post-test randomized controlled trial will test our hypothesis that an 8-week PWC skills training intervention will produce greater improvements in children's PWC skills capacity immediately after the intervention and at an 8-week follow-up assessment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe CP (Gross Motor Function Classification System Level IV or V)
* Inability to functionally walk or functionally propel a manual wheelchair as assessed by the Principal Investigator a licensed physical therapist
* Demonstrate cause and effect skills in the IndieTrainer consistent with an Assessment of Learning Powered mobility use (ALP Assessment) Phase 4 or higher (i.e., understand that they are moving the IndieTrainer using the switch(es) or joystick) as assessed by the Principal Investigator, a licensed physical therapist.
* In addition, one parent/caregiver must be conversant in English and be able to provide their child's medical and health history and be willing to take on the parent participant role.

Exclusion Criteria:

* The inability to sit in their own manual wheelchair or adaptive stroller for 60 minutes (as this would preclude them safely using the IndieTrainer System for the 60-minute intervention sessions)
* Their manual wheelchair or adaptive stroller cannot be safely used with the IndieTrainer System
* They already have an individually prescribed power wheelchair
* If the Principal Investigator, a licensed physical therapist, determines that based on the child's medical and health history, that they cannot safely participate in power wheelchair skills training.
Rural-urban Disparities in the Nutritional Status of Younger Adolescents in Tanzania.

Africa faces rapid urbanization, has the second highest population growth rate, makes up one-fifth of the world's youth population, and experiences stagnant rates of undernutrition. These challenges point to the need for country-specific data on rural-urban health disparities to inform development policies. This cross-sectional study examined disparities in body mass index-for-age-and-sex (BAZ) and height-for-age-and-sex z-scores (HAZ) among 1125 adolescents in Tanzania. Rural-urban disparities in nutritional status were significant and gendered. Findings confirm place of residence as a key determinant of BAZ, HAZ, and stunting among adolescents in Tanzania. Targeted gender-sensitive interventions among adolescents, particularly in rural areas, are needed to limit growth faltering and improve health outcomes.

Africa faces rapid urbanization, has the second highest population growth rate, makes up one-fifth of the world's youth population, and experiences stagnant rates of undernutrition. These challenges point to the need for country-specific data on rural-urban health disparities to inform development policies. This cross-sectional study examined disparities in body mass index-for-age-and-sex (BAZ) and height-for-age-and-sex z-scores (HAZ) among 1125 adolescents in Tanzania. Pearson's chi-square tested associations between rural/urban residence and undernutrition (BAZ \<-2SD), stunting (HAZ \<-2SD), anthropometric, socioeconomic, and health indicators. Multivariate linear regression identified predictors of BAZ and HAZ.

Funding: UNICEF/ Tanzania; United States National Institute of Mental Health (R01 MH66801).

Eligibility Criteria:
Inclusion Criteria:

* Adolescents between 10 and 14 years of age

Exclusion Criteria:

* Adolescents living away from the districts and not physically present at the time of the study
Study of the Treatment of Articular Repair (STAR)

This study is a prospective, longitudinal, multi-center, within patient evaluation of patients with articular cartilage defects of the knee who have had an inadequate response to a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months up to 48-months.


Eligibility Criteria:
Inclusion Criteria:

* Provided written informed consent
* Documented history of at least one Grade III or Grade IV defect (modified Outerbridge classification) on the medial or lateral femoral condyle or trochlea
* Failed prior treatment for articular cartilage defects of the knee, e.g. inadequate response to a non- ACI surgical procedure to treat the lesion, within past 3 yrs
* Patient reported overall knee condition of 5 or less on the Modified Cinn Rating System
* patients must have had a cartilage defect located on the medial or lateral femoral condyle or trochlea which had an inadequate response to a prior arthroscopic or other non-Carticel surgical repair procedure

Exclusion Criteria:

* see above
Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male who are ≥19, \<50 years old
* Man who weights over 55kg and whose BMI is 18\~30(kg/m2)
* Man who doesn't have any chronic disease or history of disease

Exclusion Criteria:

* man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry
MEN-10755 in Treating Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating patients who have solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose of MEN-10755 in patients with solid tumors. II. Determine the qualitative and quantitative toxic effects of this drug and study the predictability, duration, intensity, onset, reversibility and dose relationship of the toxic effects in this patient population. III. Propose a safe dose for phase II study. IV. Study the pharmacokinetics of this drug at different dose levels in this patient population. V. Document any possible antitumor activity of this drug in this patient population.

OUTLINE: This is a dose escalation study. Patients receive MEN-10755 IV over 15 minutes on days 1, 8, and 15. Treatment continues every 4 weeks, or upon recovery of toxicity, whichever comes later. Treatment continues for at least 2 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of MEN-10755 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for at least 3 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor that is not amenable to standard therapy Measurable or evaluable disease No brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Liver function tests no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: LVEF at least 50% (by MUGA) Other: Not pregnant or nursing Fertile patients must use effective contraception No active infections No other nonmalignant disease that precludes study No history of alcoholism, drug addiction, or psychotic disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, and high dose carboplatin) No other concurrent antitumor drugs Endocrine therapy: No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) No concurrent radiotherapy Surgery: Not specified Other: No prior anthracyclines or anthracenediones No other concurrent investigational drugs