cyrilzakka/clinical-trials huggingface dataset:
Sit-to-stand Training in Stroke Patient

Background: It is unknown whether the self-initiated sit-to-stand training with assistive device is effective to regain the independence of sit-to-stand in stroke patients.

Objective: To compare the effectiveness of self-initiated sit-to-stand training by assistive device, with manual sit-to-stand training.

Design: Parallel randomised controlled and assessor blinded trial between Jan 2015 and May 2018. Randomisation was performed by drawing lots to allocate treatment to patient.

Setting: A rehabilitation hospital in Hong Kong

Participants: 69 patients in medical wards with unilateral hemiparetic stroke. 52 patients fulfilled the study requirements.

Intervention: Ten sessions of intervention with conventional physiotherapy program followed, by self-initiated sit-to-stand training with assistive device, or by manual sit-to-stand training.

Main outcome measure: Number of patients regained the independence of sit-to-stand, Sit-to-stand test from the balance master® and Five-repetitions sit-to-stand test.

Results: 69 patients (intervention n=36; control n=33) were randomized (mean age 69.8 (SD, 10.6), mean post stroke days 18.6 (SD 16.0)) for intention to treat analysis. 17 patients were excluded because of dropout before 10 sessions of training, leaving 52 (n=26; n=26) patients for per protocol analysis. 18 patients in intervention group and 10 patients in control group had regained the independence of sit-to-stand (Phil and Cramer's V: -0.31 and 0.31). The patients in intervention group were faster to complete the Five-repetition sit-to-stand test than the control group (32.7 secs (SD, 1.93) v 48.4 secs (SD, 6.8); 95% confidence interval, -30.8 to -0.7; p\<0.05). No adverse side effects occurred during and after the training across groups.

Conclusions: Self-initiated sit-to-stand training by assistive device can help more stroke patients regain the independence of sit-to-stand.


Eligibility Criteria:
Inclusion Criteria:

* first episode of unilateral stroke with hemiparesis,
* able to understand and follow simple verbal instructions,
* able to sit unsupported for at least two minutes
* require lifting assistance to stand up from a 18 inches high plinth

Exclusion Criteria:

* severe pain in the lower extremities when weight bearing or performing movement
* any other acute comorbid diseases such as unstable angina, recent myocardial infarction
* unstable medical / psychological condition
The Exploration of the Regulatory Effect of Magnesium on Intestinal Flora in Healthy Adults

In this A Single-center, Prospective, Self-controlled trial, subjects should avoid a high-magnesium diet for 1-3 weeks and take magnesium supplements for 4-6 weeks.

Investigational drug# Oral magnesium Study title# To explore the regulatory effect of magnesium on intestinal flora in healthy adults # A Single-center, Prospective, Self-controlled trial.

Principal Investigator# Professor Yu Chen, Department of Gastroenterology, The Seventh Affiliated Hospital, Southern Medical University.

Professor Peng Chen, Department of Pathophysiology, School of Basic Medical Sciences, Southern Medical University.

Study subjects# Healthy adult, Age 20-30 years Study phase# Investigator Initiated Trial(IIT) Study objectives# The objective of the study is to explore the regulatory effect of magnesium on intestinal flora in healthy adults Study design# A Single-center, Prospective, Self-controlled trial. Medication method# Subjects should avoid high magnesium diet for 1-3 weeks, and take magnesium supplement (food grade magnesium citrate: three capsules a day, after meals, 400mg magnesium) in 4-6 weeks. Peripheral blood and stool samples were collected from 60 subjects on day 0, day 21, and day 42 of the study period for routine blood tests, blood biochemical tests, and 16s rDNA sequencing analysis of gut microbiota.

Course#42days Sample size#60.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 20-30 years in the general community
* Without gender or ethnic requirements, who did not participate in other trials at the same time, volunteered to participate in this study
* No underlying diseases.

Exclusion Criteria:

* (1) Patients who have taken antibiotics orally in the past 3 months or have acute or chronic inflammation;
* (2) Those who have taken hormones within 3 months;
* (3) Those who have taken drugs that may interfere with glucose and lipid metabolism (such as insulin, glyburide, indomethacin, phentolamine, fuuside, phenytoin sodium, cortisone, etc.) and those who have taken probiotics within 1 month;
* (4) smokers and drinkers;
* (5) Uncontrollable mental disorders (including hospitalization history of mental illness);
* (6) Currently attending a weight loss or weight management course;
* (7) prescribed diet for specific or other reasons (e.g. celiac disease);
* (8) pregnant or lactating women;
* (9) Patients with cardiac and renal insufficiency;
* (10) Long-term constipation.
MDs on Botox Utility (MOBILITY)

The MOBILITY Project is a prospective, non-randomized, observational, multi-centre evaluation of Health Utility via the SF-12® Health Survey Scores and the SF-6D in patients receiving BOTOX® for therapeutic use.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible for BOTOX® treatment deemed medically necessary by their physician
* Patient (and/or patient's authorized legal representative) should provide written informed consent; a patient under the age of 18 must review and sign the Patient Assent Form
* Patients at the age of or over 14

Exclusion Criteria:

* Patient is participating in a clinical trial for any BOTOX® indication
* Patient with any contraindications to use botulinum toxin A
Safety Evaluation of Linear and Macrocyclic Gadolinium Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging

The purpose of this study is to evaluate the safety of linear and macrocyclic gadolinium-based contrast agents for patients with mild to moderate renal insufficiency. The study will compare the incidence of adverse events of gadodiamide and gadoteric Acid Meglumine Salt for patients with mild to moderate renal insufficiency undergoing enhanced magnetic resonance imaging.

According to the requirements of the study, 600 cases of patients with mild to moderate renal insufficiency were enrolled. Gadodiamide and Gadoteric acid meglumine salt were used for enhanced MRI. Observe the adverse reactions within 60 minutes of using the gadolinium contrast agents; follow up by telephone at 3, 6, 12, and 24 months after the inspection. The primary endpoint is the incidence of the various adverse events, and the secondary endpoints are changes of serum creatinine and inflammatory factors (TNF-α, hs-CRP, IL-6) before and after CE-MRI, patient skin examination and evaluation (evaluation of relevant indicators of skin biopsy).

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 80 years old who require gadolinium-based CE-MRI;
2. Patients with renal function 30ml/min/1.73m2≤eGFR\<90/min/1.73m2;
3. Patients who are able and willing to comply with the required inspection requirements.

Exclusion Criteria:

1. Patient who experienced allergic reactions to previous gadolinium-based contrast agents;
2. Patient who had used gadolinium-based contrast agents within 3 months;
3. Patient with acute renal failure;
4. Patient who cannot comply with or cannot tolerate the necessary fluid replenishment procedures;
5. Patient with major mental illness, impaired consciousness, or other diseases considered by researchers to affect observation.
Effect of Physical Activity on Depressive Symptoms With a 5 Month Follow-up

The main objective of this study is to evaluate the effect of a 12 weeks adapted physical activity program (active walking) on depression by analyzing the dynamics of emotional and cognitive functioning. The secondary objectives are to test the effects of a physical activity on functional performance and to highlight psychological mechanisms.

Primary outcomes:

Self evaluations concerning global self-esteem, a perception of competence and satisfaction in the physical self and four sub-domains that are perceived physical endurance, perceived competence in sports, perceived physical force and perceived physical appearance, are performed.

Assessment of depressive symptomatology is also realised including momentary levels of depression, anxiety, rumination, efficacy of coping strategies and quality of life.

Secondary outcomes:

Assessment of postural control

Eligibility Criteria:
Inclusion Criteria:

* Speaking French
* Aged between 18 and 65 years
* Diagnosed with current major depressive disorder
* BDI II score ≥ 12
* IPAQ score \<600

Exclusion Criteria:

* Alcohol or substance(s) dependence(s)
* Psychotic disorders
* Anti-social personality
* Pregnant or nursing women
* Physical inability to perform active walking
Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease

Randomized clinical trial to test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease

This is a single center randomized controlled clinical trial consisting in 2 treatment groups.

All patients admitted at University Hospital of Tarragona Joan XXIII with Sacrococcygeal pilonidal disease were likely to enter in the study. All patients with uncomplicated sacrococcygeal disease, localized in the midline and with only 1 fistulous orifice.

When the patients met the criteria and after consenting the admission in the study, they were included and were operated. The patients were randomly assigned to the phenolization group or conventional-surgery group. A unique anesthetic and surgical protocol were established for both groups.

Patients in the phenolization group underwent curettage with an otorhinolaryngology spatula and endocavitary phenol with an abocath needle until complete coagulation of the cyst. Patients in the conventional-surgery group were referred to conventional surgery consisting of complete excision of the cyst and closure by second intention. Both groups were managed without admission and discharged within a few hours if they met ALDRETE criteria. They were followed daily by the home hospitalization team

The main endpoint was short or medium-term recurrence of sacrococcygeal disease. The number of recurrences per group and the time from surgery to recurrence were assessed. Secondary endpoints included degree of satisfaction and sick leave

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* ASA (american society anesthesiologists) less than or equal to 3
* patients who live accompanied in a home at a maximum distance of 30 minutes from the hospital
* adequate cognitive capacity

Exclusion Criteria:

* pregnancy or breastfeeding
* complicated Sacrococcygeal pilonidal disease
* non-randomized surgical management
Accuracy of a Continuous Ketone Monitoring (CKM) System in Individuals with Type 1 Diabetes on Insulin Pump Therapy.

The goal of this 14-day randomized pilot trial is to assess the accuracy of a continuous ketone monitoring (CKM) system when compared to standard point-of-care capillary ketone monitors in individuals with type 1 diabetes on insulin pump therapy. The main question it aims to answer is:

- Can a CKM system demonstrate equivalent ketone monitoring compared to a capillary ketone monitor with accuracy within a mean absolute difference of no more than ± 0.1 mmol/L.

Participants will be asked to wear the SiBio KS1 CKM system for 14-days while undergoing two sequential ketogenic diets which are interspaced by an inpatient insulin-suspension period.

In this study, all study participants will wear the CKM system and collect multiple standard point-of-care capillary ketone measurements. Therefore, there will be two groups in terms of measurements methods, one acting as an active comparator (the CKM system) and, the other serving as a control (point-of-care capillary ketone measurements). Both groups of measurement methods will be assessed in all study participants for both the outpatient phase (sequential ketogenic diets) and, the inpatient phase (insulin-suspension period) of the study to evaluate the accuracy of the CKM system.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 18 years of age.
2. A clinical diagnosis of type 1 diabetes (T1D) for at least one year, as per their treating diabetes physician in agreement with the primary investigator's clinical judgment (confirmatory C-peptide and antibodies will not be required).
3. On stable, commercial closed-loop pump therapy for the past 30 days.
4. Stable use of continuous glucose monitor system for the past 30 days.
5. Cellular phone with Android OS operating system 8.1 and above or iOS11 and above operating system, for data compatibility with continuous ketone monitor mobile app (SiCKM app).
6. Able to perform study related tasks.

Exclusion Criteria:

1. Current or ≤ 2 weeks use of sodium-glucose cotransporter-2 (SGLT2) inhibitor medication (e.g. empagliflozin).
2. Current use of ascorbic acid (Vitamin C) as it may impair accuracy of the sensor.
3. Severe hypoglycemic episode within one month of admission, defined as an event where glucose was \<4 mmol/L resulting in seizure, loss of consciousness, needing third party assistance, or need to present to the emergency department.
4. Diabetic ketoacidosis episode requiring medical attention or intravenous insulin within one month.
5. Planned or ongoing pregnancy or breastfeeding individuals.
6. Any serious medical or psychiatric illness likely to interfere with ability to complete the trial, as per judgement of investigators.
Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2

Vitamin D Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of CKD stage 1 and 2
* Age \>18 years
* Ability to provide informed consent

Exclusion Criteria:

* On vitamin D in past 4 weeks
* Plans to relocate out of Taixing City in the next one year
* Serum phosphate \>5.5 mg/dl in past 3 months
* Serum calcium \>10.0 mg/dl in past 3 months
* Cancer
* Transplanted organ
* Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
French Single Centre Experience of Critically Ill Patients With Covid 19

Since the outbreak of a syndrome of acute respiratory distress associated to a novel coronavirus 2 (SARS-Cov2) that began in China, Europe and France have to face a sanitary emergency with critically care support when the patient evolves to an acute respiratory distress (ARDS). In the context of supply shortages (ventilators, bed capacities) that countries have to deal with, data were lacking of characteristics and outcomes of patients admitted to intensive care unit (ICU). the purpose of this project is to report the epidemiology and the outcomes of a French cohort of critically ill patients with SARS-Cov2


Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* patient with positive rRT PCR of SARS Cov2 on a sample of nasopharyngeal swab
* admission in intensive care unit

Exclusion Criteria:

* patient under 18 years old
ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa

Study wants to explore real-world data in three distinct settings

* Patients with metachronous or de novo mCSPC treated with ADT+ARSI or ADT+ARSI+docetaxel _ARON-3S
* Patients receiving Lutetium-177 PSMA for mCRPC _ ARON-3Lu
* Patients treated with PARP inhibitors (alone or combined with ARSI) for CRPC _ ARON-3GEN


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18y
* Cytological or Histologically confirmed diagnosis of PC
* Histologically or radiologically confirmed diagnosis of metastatic disease and

For ARON-3S

▪ Treatment with ADT + Apalutamide or ADT + enzalutamide or ADT + Abiraterone or ADT + Abiraterone + Docetaxel or ADT + Darolutamide + Docetaxel (patients treated with previous docetaxel - CHAARTED - resulted eligible)

For ARON-3Lu

▪ Treatment with Luthetium-177-PSMA therapy for castration resistant PC

For ARON-3GEN

* HRD POSITIVE STATUS
* Treatment with PARP inhibitors for castration resistant PC. Treatment included: olaparib (as 1st, 2nd or 3rd line therapy), olaparib + abiraterone (as 1st line therapy) or niraparib + abiraterone (as 1st line therapy) or talazoparib + enzalutamide

Exclusion Criteria:

* Patients without histologically confirmed diagnosis of PC
* Patients without histologically or radiologically confirmed metastatic disease and

For ARON-3S

▪ Patients treated with doublets or triplets not included in the list reported in the Inclusion Criteria Section

For ARON-3Lu

▪ Patients treated with Luthetium-177-PSMA therapy for hormone/castration sensitive PC

For ARON-3GEN

* HRD NEGATIVE STATUS
* Patients treated with PARP inhibitors alone or in combination regimens not included in the ARON-3GEN study
Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players

Background and justification: Women's football has a percentage of knee injury of 31.8%, and the anterior cruciate ligament lesion is between 2 and 4 times higher than the male. Injury prevention programs seek to improve the control of the neuromuscular recruitment, dynamic valgus and lumbopelvic stabilization. Recently Cibulka and Bennett have proposed a new prevention theory based on the strengthening of the external abductor and hip rotator muscles. The objective of this study is to design and carry out a physiotherapy program based on the prevention of modifiable risks factors.

Design: Controlled clinical trial

Methodology: 2 groups were formed, the first or experimental integrated by the female players from football team called CD Oliver (CDO), and control, integrated by the female players of the first team SD Huesca (SDH). The investigators will carried out an initial and final evaluation in which they will be collected data on variables of injury incidence, muscle length and torque. A physiotherapy program will be implemented that will consider three areas of weekly action during training, preventive force sessions, compensatory force sessions and physiotherapy sessions.


Eligibility Criteria:
Inclusion Criteria:

* Have a valid federal license signed by the competent medical authority.
* Be part of a team registered in the federated league.
* Train 4 and a half hours a week or more.
* Compete and train in regulatory fields, with artificial grass.
* Have a staff composed of a qualified technician, registered and in possession of the corresponding validated license.
* Sign the informed consent.

Exclusion Criteria:

- Suffering a lower limb injury at the start of the study.
A Study Of CP-690,550 In Stable Kidney Transplant Patients

This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.


Eligibility Criteria:
Inclusion Criteria:

* Medically stable kidney transplant patients 6 or more months after transplantation.
* Subjects must be on mycophenolate mofetil 1-2 gm daily
* In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2, subjects must be on a calcineurin inhibitor-free regimen.

Exclusion Criteria:

* Any rejection episodes in the preceding 3 months.
* Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.
Safety and Immunogenicity of a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children

A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and immunogenicity demonstrated in the phase III trial in China. A large scale, double blind, randomized, PNEUMOVAX 23 (Merck \& Co., Inc.) controlled phase 3 clinical trial was conducted.

The World Health Organization (WHO) estimated that more than 800 000 children younger than 5 years died from pneumococcal disease in 2000, making it the leading vaccine-preventable cause of death. Pneumococcal polysaccharide vaccines have progressed from 2-valent vaccines to the current 23-valent vaccine, which has been available since the early 1980s. The 23-valent vaccine includes serotypes accounting for 72% to 95% of invasive pneumococcal disease, depending on the geographic area. Many countries have added pneumococcal polysaccharide vaccine to their existing national immunization programs or recommended it for people aged 65 years and older and for individuals aged 2-64 who are at increased risk of pneumococcal disease.

A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and immunogenicity demonstrated in the phase III trial in China. A large scale, double blind, randomized, PNEUMOVAX 23 (Merck \& Co., Inc.) controlled phase 3 clinical trial was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants older than 2 years were recruited and enrolled in September or October 2012.
* Participants with axillary temperature less than Celsius 37 degrees
* Not yet having received pneumococcal vaccine and other prevention products within 7 days.

Exclusion Criteria:

* Exclusion criteria were any known primary or secondary immunodeficiency
* Allergy
* Severe cardiovascular disease bleeding disorders
* Receipt of immunoglobulin or blood products within one month and so on.-
Effect of Class IV Laser Therapy and Pilates Exercises on Bone Density and Pain in Primary Osteoporosis: A Randomized Controlled Trial

the current study was to investigate the effect of class IV laser therapy and Pilates exercises on bone density in Osteoporosis.Sixty patients with osteoporosis (T-score values below -2.5) in lumbar spine with no evidence of vertebral compression fractures were recruited from October 6 University Hospital and Kaser El-aini Hospital, Cairo - Egypt from February 2019 to November 2019. Their age ranged from 40 to 60 years old. Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc prolapse, or any trauma to the back area were excluded from the study

They were allocated randomly into three groups: Group A consists of 20 patients received a multiwave locked system laser, group B consists of 20 patients received Pilates exercises and group C consists of 20 patients received a multiwave locked system laser and Pilates exercises. Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc prolapse, or any trauma to the back area were excluded from the study. All patients who participated in the current study did not intake any medications to accelerate bone density like vitamin D or calcium. The randomization method was applied by asking each patient to choose a piece of paper that the (A), (B), or (C) letter was written. (A) considered the LLLT group, (B) considered the Pilates exercise group, while (C) considered the LLLT and Pilates exercises group. Both patients, the examiner, and therapist were blinded from the selection process.

Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoporosis (T-score values below -2.5)

Exclusion Criteria:

* Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc prolapse, or any trauma to the back area