cyrilzakka/clinical-trials huggingface dataset:
The Safety and Performence of ShockPulse-10 in Patients with Coronary Artery Calcification

This study is an exploratory, multicenter, single-group clinical trial aimed to evaluate the clinical outcomes of using ShockPulse-10 in the treatment of coronary artery calcification .

The study will be conducted at 8 sites in China and up to 205 participants will be followed for 180 days post procedure.

Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate procedure success,procedure success defined as successful stent implantation, residual stenosis degree ≤30% , and no major adverse cardiac events (MACE) occurring during hospitalization.

Eligibility Criteria:
Key Inclusion Criteria:

1. Patient is ≥ 18 years of age;
2. Patients with significant coronary artery disease (including stable or unstable angina and asymptomatic myocardial ischemia) who are suitable for PCI treatment;
3. A single newly developed stenosis of the target vessel, which is the left anterior descending artery, right coronary artery, or circumflex artery (or its branches), with stenosis degree ≥70% or ≥50% (Visually inspect ) and accompanied by evidence of ischemia;
4. The target lesion is a primary, in situ coronary artery lesion;
5. The reference vessel diameter for the target lesion is 2.0-4.0mm, and the length of the target lesion is ≤40mm (Visually inspect);
6. Visual assessment indicates that the lesion site can accommodate the passage of a pre-dilator or trial instrument through the lesion;
7. The target lesion site has moderate to severe calcification (meeting one of the following conditions)：

   ① Angiography: Moderate calcification :clearer and more easily visible high-density shadows during cardiac pulsation; Severe calcification :clear high-density shadows both during and at rest;

   ② IVUS calcium score ≥2 points for superficial intimal, deep medial, and mixed calcification;
8. TIMI grade 3 in target vessel before registration (pre-dilation is allowed);

Key exclusion Criteria:

1. Left ventricular ejection fraction \< 40%；
2. NYHA class III or IV heart failure；
3. Patients with single coronary artery supply;
4. Patients with evidence of dissection at the site of the lesion on imaging;
5. The imaging suggests that the vascular pathway is tortuous, making it difficult for the pre-dilatation device to reach the target location or to be retrieved;
6. Patients with active systemic infections;
7. Patients with uncontrollable severe hypertension (systolic pressure \> 180 mmHg or diastolic pressure \> 110 mmHg);
8. Patients with coagulopathy, hypercoagulable state or significant bleeding tendency (hemoglobin \<10g/dL or platelet count \<80×10\^9/L);
Effect of Fast Inpatient Rehabilitation After TKA

Rehabilitation is an important part of the post-operative treatment after TKA by consensus. This study intends to analysis whether fast inpatient rehabilitation after TKA can improve knee joint or general function, and ultimately explore for effects and values of fast inpatient rehabilitation after TKA.

Rehabilitation, which is an important part of the post-operative treatment after TKA, could effectively alleviate symptoms of pain and swell, as well as improve knee joint and general function. It has reached a consensus that post-TKA rehabilitation should contain muscle strengthening, ROM, proprioceptive, balance training and physical factor therapy, etc. This study intends to use observational cohort study methods with exposure factor of fast inpatient rehabilitation after TKA, establish a TKA exposure group and a control group of TKA without inpatient rehabilitation, analysis whether fast inpatient rehabilitation after TKA can improve knee joint or general function, and ultimately explore for effects and values of fast inpatient rehabilitation after TKA.

Eligibility Criteria:
Inclusion Criteria:

* Initial unilateral TKA patients due to osteoarthritis, rheumatoid arthritis, etc.
* Satisfactory operative knee joint ROM: knee flexion ≥120° and extension ≥ 0°.
* Prior informed consent by patients.

Exclusion Criteria:

* Complication of other medical conditions and disability to cooperate with rehabilitation.
* Complication of other conditions affecting bilateral lower limbs such as fracture, tumor, neurologic disorder, etc.
* Deep venous thrombosis of lower limbs with exception of inter-muscular venous thrombosis.
Distribution of FMT After Delivery by · Lower GI Endoscopy vs Enema With and Without Positioning of the Patient

While delivery of an FMT-treatment to the cecum is visualized in a lower GI-endoscopy, it is uncertain whether delivery by enema distributes the FMT to the proximal segments of the colon. Positioning of the patient during the enema procedure may improve distribution to the proximal colon. Differences in distribution may explain the wide effect range and inferiority when enema is compared to delivery by lower GI endoscopy. Thus, in this study we will compare the distribution of FMT from delivery by lower GI endoscopy versus enema with and without positioning of the patient. We will use contrast fluid as a surrogate liquid for FMT to project the distribution on colon X-ray pictures. To our knowledge this is not done in any previous study.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for colonoscopy at the medical department at UNN Harstad
* Able to complete the positioning procedure during the enema

Exclusion Criteria:

* Confirmed malignancy
* Inflammatory bowel disease
* Referral highly suspicious of cancer, inflammatory bowel disease or obstructive GI disease
* Contraindications for rectal catheter insertion (including known damage to pelvic floor, sphincter or the pudendal nerve)
* Use of anticoagulants. Use of acetylsalicylic acid is allowed
* Symptomatic cardiovascular or lung disease
* Kidney failure
* Known allergic reaction to any component in Liquid Polibar Plus
* Pregnant, lactating or planning pregnancy
* Asthma
Comparative Effect of Functional Task Training Versus Function Therapy Program

cerebral palsy is the brain injury or brain malformation occur before, during and immediately after birth (while brain is still under development) and its effect muscle tone, reflexes, posture coordination gross and fine motor skill and oral motor functioning. The functional training is the physiotherapist and occupational therapy rehabilitation technique focus on strength and function of musculoskeletal system and its help the patients to making their daily life activity easier. The functional task training program consisted of non-walking (i-iii) and walking (iv-v) activities: (i) standing from a seated position; (ii) reaching for an object overhead, which required ankle plantar flexion from the standing position, and returning to the initial position with the heel leaning on the floor; (iii) stepping on and off a bench; (iv) walking up and down stairs; and (v) walking on flat surfaces and ramps. Children with cerebral palsy frequently receive. functional therapy programs the children participated in activities pertaining to everyday skills such as eating, playing, communication, and mobility. To optimize the child's opportunities to practice towards the goals, parents and preschool staff were guided on efficiently encouraging the child. Support and instructions from the professional to help them to develop better motor skills and increase independence in tasks like self-care, play, and recreational activities.so the study aimsto improve balance, gross motor function, and range of motion by using these functional training task and functional therapy program. In my study compare the compare task training versus functional therapy programsm on gross motor function, range of motion on, and balance in cerebral palsy children.

The randomized control trial will be conducted through convenient sampling. There will be two group the experimental group will receive functional task training. according to GMFS, Pediatric balance scale and goniometer to assess the gross motor function, ROM and balance in cerebral palsy, while control group will receive functional therapy program (bobath technique) to improve gross motor function, ROM and balance in cerebral palsy. The duration of the treatment will be 8 weeks. Gross motor function, pediatric balance scale, and goniometer will be used as outcome measure. Data will be analyzed on spss version 29, normality of the data will be checked and test will be applied according to the normality of the data either in will be parametric test or nonparametric based on the normality

Eligibility Criteria:
Inclusion Criteria:

* Both gender
* GMFCS (Gross Motor Function Classification System) score is in between 1-2,
* Ability to follow command
* Cerebral palsy diagnosed child (
* Age 6-12yr

Exclusion Criteria:

* • Deformity like scoliosis. pelvic, oblique, and hip deformity

  * Age more than 16
  * Visual disorder
  * Mental retardation
Registry of First-line Treatments in Patients With Critical Limb Ischemia

The principal research question is which treatment modality between open surgical, endovascular and conservative therapy is the most effective in terms of limb salvage, survival and reinterventions in patients with critical limb ischemia

The target population consists of patients suffering from critical limb ischemia (CLI) lasting more than 2 weeks. CLI is defined as rest pain or tissue loss (Fontaine stages III-IV or Rutherford classes 4 to 6) and/or ankle-brachial index \< 0.40. Patient with acute limb-threatening ischemia, bone fractures in the relevant areas, nonatherosclerotic disease (e.g. arteriitis) and documented hypercoagulable diseases will be excluded from this study. There will be no experimental or control groups. The comparison groups will be:

Group 1: Best endovascular treatment (angioplasty +/- stent) Group 2: Best surgical treatment \[bypass (vein or prosthetic)\] Group 3: Femoral artery patchplasty +/- profundoplasty (+/- endovascular treatment) Group 4: Best conservative treatment

The proposed sample size amounts to 1200 patients.

To be assessed for eligibility (n=1200) To be allocated to trial (n=1000) To be analysed (n=900)

In CRITISCH registry, randomization or blinding is not feasible, because optimized standard care will be performed as established at each participating centre (best medical treatment). Data storage, validation, monitoring, update, backup and analysis will be performed centrally following established procedures. Web-based software will be used to develop a data model representing the data structure. The data validation will include standard data validation techniques such as the manual review of selected variables and the routine check of missing and outlying data points. Regional staff will be instructed and supervised by study nurse, who will perform the study monitoring. Assessment of relevant prognostic factors during the statistical analysis will prevent biased results due to the non-randomized design and the potential structural inequality.

Eligibility Criteria:
Inclusion Criteria:

* Rest pain or tissue loss (Fontaine stages III-IV or Rutherford classes 4 to 6) and/or ankle-brachial index \< 0.40

Exclusion Criteria:

* Acute limb-threatening ischemia
* Bone fractures in the relevant areas
* Non-atherosclerotic disease (e.g. arteriitis)
* Documented hypercoagulable diseases
Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients

Postoperative agitation (hyperactive delirium) is common following major surgery(incidence was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine is useful on reducing postoperative delirium. The hypothesis of present study: intraoperative application of dexmedetomidine (0.2ug/kg/h) is is effective (50% reduce) than placebo for reducing of early postoperative delirium and increase postoperative quality of recovery within 24 postoperative hours.

After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of adult patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I-III, undergoing selective major surgery under general anesthesia. All the patients were randomly assigned to receive dexmedetomidine or placebo during the operation. The primary outcome measure was postoperative delirium assessed by Nursing Delirium Screening Scale (Nu-DESC) every 8 hours within 24 postoperative hours. The secondary outcome was length of postanesthesia care unit (PACU) stay,postoperative hospital length of stay, hemodynamic parameters, the incidence of postoperative nausea and vomiting, and quality of recovery determined by quality of recovery (QOR40; maximum score 200)and Post-operative Quality Recovery Scale (PQRS) in the first 24 h after surgery.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status class I-III
* Aged 60 years or above
* Elective major surgery under general anesthesia

Exclusion Criteria:

* ASA-PS\>=IV
* Aged under 60 yr old
* Body mass index (BMI) \>30
* Neurologic disease
* Cardiac surgery and neurologic surgery
* Anticonvulsant drugs
* Chronic analgesics intake
* Participating in the investigation of another study
Probiotics Improve Adult Allergic Rhinitis and Regulate Gut Microbiota

Assessing the clinical efficacy of weizmannia coagulans BC99 in alleviating allergic rhinitis symptoms, improving gut microbiota, and reducing adverse reactions in patients.


Eligibility Criteria:
Inclusion Criteria:

Voluntarily and in writing, sign an informed consent form agreeing to participate in this study; Able to complete the study as required by the trial protocol; Age between 18 and 65 years old; Meet the diagnostic criteria for allergic rhinitis established in the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022 Revised Edition)"; Symptoms: Presence of two or more symptoms such as sneezing, watery rhinorrhea, nasal itching, and nasal congestion, with daily symptoms lasting or accumulating for more than 1 hour, which may be accompanied by eye itching, tearing, and redness of the eyes and other ocular symptoms; Signs: Pale and edematous nasal mucosa, which may be accompanied by watery secretions.-

Exclusion Criteria:

Use of drugs affecting the gut microbiota (including antimicrobial agents, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines, etc.) for more than 1 week within 1 month prior to screening; Patients with coexisting pulmonary tuberculosis; Patients with coexisting allergic asthma; Patients with nasal polyps or severe nasal septum deviation; Patients with severe systemic diseases or malignant tumors; Individuals with congenital genetic diseases or congenital immunodeficiency diseases; Regular use of probiotics or prebiotics within 6 months prior to the screening period; Patients with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel diseases, etc.); Individuals with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.); Patients with sinusitis, otitis media, or respiratory tract infections; Individuals allergic to any components of the probiotics used in this trial; Pregnant or lactating women or those planning to conceive in the near future; Those who discontinue the test sample or take other medications midway, making it impossible to determine efficacy or with incomplete data; Recent use of products similar to the test function, affecting the judgment of the results; Participants who cannot participate in the trial due to their own reasons; Other participants deemed ineligible by the researcher. -
Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed Multiple Myeloma

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with cyclophosphamide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with cyclophosphamide works in treating patients with high risk, refractory, or relapsed multiple myeloma.

OBJECTIVES:

* Determine the effect of rituximab and high-dose cyclophosphamide on the growth of myeloma stem cells in patients with high-risk, refractory, or relapsed multiple myeloma.

OUTLINE: Patients receive rituximab IV on days -10 and -7; once weekly for 4 weeks (after completion of high-dose cyclophosphamide); and then once in months 3, 6, 9, and 12. Patients also receive high-dose cyclophosphamide on days -3 to 0.

PROJECTED ACCRUAL: Not specified.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of multiple myeloma, meeting 1 of the following criteria:

  * High-risk disease in first remission, as defined by the following:

    * Beta-2 microglobulin \> 5.0 mg/dL
    * Chromosome 13 deletion
  * Primary refractory disease
  * Relapsed disease after achieving a response to prior chemotherapy
* The following diagnoses are not allowed:

  * POEMS syndrome
  * Plasma cell leukemia
  * Amyloidosis
  * Nonsecretory myeloma
* No evidence of spinal cord compression

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* Has good organ function
* Is in good physical condition
* No active infection requiring antibiotics
* No other malignancy within the past 2 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No persistently detectable donor cells after prior allogeneic stem cell transplantation
* No prior rituximab

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 28 days since prior therapy
Sit-to-stand With Feedback in SCI Patients

* Does the utility of external feedback in terms of goal-directed LLL approach during STS training immediately improve functional ability relating to walking in ambulatory patients with SCI?
* Does the utility of LLL feedback improve functional ability relating to walking in ambulatory patients with SCI after 2-week training?

* To compare immediate effects of STS training with and without LLL feedback on functional ability relating to walking in ambulatory patients with SCI
* To compare 2 weeks effects of STS training with and without LLL feedback on functional ability relating to walking in ambulatory patients with SCI.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory spinal cord injury patients

Exclusion Criteria:

* Deformity of musculoskeletal system
MBCGT and Psycho-physiological Stress Regulation Group for Depression and Psycho-physiological Stress Patient

Cases of physical and psychological stress problems is the need to prevent the risk of depression, primary care model will help to prevent depression. Many scholars have advocated for depression treatment not only concern symptom control and relief, prevention of recurrence should also be aware. The literature found cases had depression, with cognitive strategy bias , may cause recurrence of depression, under the influence of stress. The study was to assist the physical and mental disorder patient caused by stress and depression patient having cognitive and emotional regulation, and increased adapting Ability by ongoing two separate treatment groups ,Mindfulness-based Cognitive Group Therapy and psycho-physiological stress regulation Group Therapy. In addition, psychological groups can also help regulation daily Trivia stress, study will try to know about how group therapy's effects on patient's immune system.Research has three purposes,to validation 2 group model's results in assisting psycho-physiological stressed and depression patient, to establish group leader training center and prepare groups' standard procedure manuals,and to understand the patient's psycho-physical stress reaction on the immune system and fat cell hormone.

The study was to assist the physical and mental disorder patient caused by stress and depression patient having cognitive and emotional regulation, and increased adapting Ability by ongoing two separate treatment groups ,Mindfulness-based Cognitive Group Therapy and psycho-physiological stress regulation Group Therapy. In addition, psychological groups can also help regulation daily Trivia stress, study will try to know about how group therapy's effects on patient's immune system.Research has three purposes,to validation 2 group model's results in assisting psycho-physiological stressed and depression patient, to establish group leader training center and prepare groups' standard procedure manuals,and to understand the patient's psycho-physical stress reaction on the immune system and fat cell hormone.

Eligibility Criteria:
Inclusion Criteria:

* Physical and mental condition caused by stress, physician diagnosed
* suffered from major depression, in remission more than three months , and had moderate or mild depressed mood

Exclusion Criteria:

* Suffering from schizophrenia or anxiety disorder .
* Chronic diseases (such as diabetes, stroke, heart disease, cancer, etc.) or major injury (such as a car accident brain injury)