cyrilzakka/clinical-trials huggingface dataset:
Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy

Patient satisfaction and safety with propofol based sedation with or without fentanyl for gastrointestinal endoscopy

This study divide patients into two groups, one will be given propofol midazolam and fentanyl; another group was given propofol with midazolam without fentanyl; to observe two groups of patients blood pressure, body movement, and propofol dosage , and the difference in operator satisfaction, and how many people need to give fentanyl again; and two groups of patients after the operation of the reaction, if there are dizziness, nausea, and other adverse reactions; finally, the differences of these two schemes in different populations were analyzed, and the rationalization and individualized medication will be put forward.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older
* Patients scheduled for an outpatient gastrointestinal endoscopy by the principal investigator.

Exclusion Criteria:

* Patients with a history of colorectal surgery
* Patients with ASA class 4 or 5,
* Patients with pre-existing hypoxaemia (SpO2\<90%),
* Patients with hypotension (SBP\<90mmHg)
* Patients with bradycardia (HR\<50 bpm)
* patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
* patients with uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* patients with pregnancy or lactation
* Patients hemodynamically unstable
* Patients unable to give informed consent
* Patients with a history of drug allergies;
A Study of the Relationship of Psychosocial Function With Mood Symptoms in Offspring of Parents With Bipolar Disorder

The primary purpose of this study is to compare, over 24 months, the time spent with clinically significant mood symptoms (ie, mania, depression), as measured by the Longitudinal Interval Follow-Up Evaluation (LIFE) and the Psychiatric Status Rating Scale (PSR), in offspring of bipolar parents with and without at least mild impairment in psychosocial functioning.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have at least one parent who meets the criteria for diagnosis of Bipolar I disorder (BD-I) or Bipolar II disorder (BD-II), as confirmed by the Mini International Neuropsychiatric Interview (MINI) administered to the parent. MINI will be administered to parent if the history of BD is endorsed by Family Index of Risk for Mood (FIRM) or other medical information (psychiatrist, medical records). The MINI can be administered to the parent remotely through the telephone or video call if an in-person interview is not feasible due to logistical reasons. A diagnosis Bipolar Disorder Not Otherwise Specified in the parent would not qualify for eligibility
* Participants must be either drug-naive, or on stable treatment for at least 4 weeks.
* Participants (and/or their parents as applicable) must sign an Informed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements and/or sponsor policy. Adolescents (minors) who in the judgment of the investigator are capable of understanding the nature of the study can be enrolled only after obtaining consent of a legally acceptable representative. Assent must be obtained from any participating adolescents (minors), if applicable
* Participants must be willing and able to complete self-reported assessments via mobile electronic device, and to wear a wrist actigraphy device for the duration of the study

Exclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV Diagnosis of bipolar I or bipolar II disorder
* DSM-IV Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
* DSM-IV Diagnosis of neurodevelopmental disorders
* An intelligence quotient (IQ) score less than (\<) 80 as determined by Kaufman Brief Intelligence Test (K-BIT)
* Uncorrected hypothyroidism or hyperthyroidism
Rewards for Cannabis Abstinence-study

The goal of this clinical trial is to investigate the (cost-)effectiveness of contingency management (CM) compared with Cognitive Behavioural Therapy (CBT) for the treatment of cannabis use disorder (CUD) in youth (16-22 years).

The main questions it aims to answer are:

* What is the efficacy of 12 weeks outpatient CM versus CBT in youths with a CUD, in terms of cannabis abstinence during the intervention period?
* What is the long-term efficacy of CM versus CBT at 6- and 12-months follow-up (FU)?
* What is the cost-effectiveness of CM versus CBT at 12-months FU from a societal perspective?

Study hypotheses are:

1. CM will result in more cannabis-abstinent days than CBT during the intervention; 2. CM is more effective and cost-effective than CBT at 12 months follow-up.

Eligible patients (n=154) will be randomly assigned to either 12 weeks of outpatient CM or CBT. Assessments are conducted by trained research-assistants at baseline, after 6, 12, 26 and 52 weeks, and twice-weekly during treatment and consist of questionnaires, a computer task and collection of urine samples. Primary endpoint is the number of biochemically verified cannabis abstinent days in the 12-week treatment period. Key secondary endpoint: Treatment response: 50% or more reduction in cannabis use days in the past 4 weeks, compared with baseline.

The primary outcome will be modelled in the intention-to-treat population in a (negative binomial) regression analysis with treatment group as independent variable and stratification variables as covariates.

Cost-effectiveness and cost-utility analysis (CEA; CUA) will be performed from a societal perspective. CEA: Treatment response is the central clinical endpoint for calculations of incremental costs per responder. CUA: Incremental costs per QALY (based on EuroQoL).


Eligibility Criteria:
Inclusion Criteria:

* Youths (16-22 years) seeking treatment for a primary CUD
* Regular cannabis use (≥14 days) in past 4 weeks
* Intention to cease cannabis use during intervention
* Able and willing to attend the treatment center and submit urine samples under supervision twice-weekly
* Informed consent.

Exclusion Criteria:

* Health contra-indications (e.g., acute psychosis/suicidality)
* Insufficient Dutch language.
Ultrasound-guided Sciatic Nerve Block in Below Knee Amputation Surgery

56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach or a sub gluteal approach. Patients in both groups received same amount of LA and additional ultrasound guided femoral nerve block to ensure sensory block of the medial side of the leg. Success of the block was considered when the block is solid and doesn't require shifting to GA

56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach (group P, n 28) or a sub gluteal approach (group G, n 28). Patients in both groups received same amount of LA (25 ml of bupivacaine 0.5 %) and additional ultrasound guided femoral nerve block by 10 ml of bupivacaine 0.5% to ensure sensory block of the medial side of the leg. Time to complete sensory and motor block, time taken to perform the block, block-related complications, block duration, time for asking for rescue analgesia in the first 24 h were recorded and both patients and surgeons were asked about their level of satisfaction. Success of the block was considered when the block is solid and doesn't require shifting to GA

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status II and III patients
* aged 45-75 years,
* undergoing elective below knee amputation

Exclusion Criteria:

* patients who refused to participate in the study,
* those having allergy to local anaesthetics,
* or having contraindications to regional anaesthesia (having neurologic or neuromuscular disease, on anticoagulation therapy, or having skin infection at the site of needle insertion).
Influence of Shunt Occlusion on Organ Functions in Hyperammonemic Patients With Cirrhosis Having Porto-systemic Shunt.

The spontaneous Porto-systemic shunt is occluded by intervention procedures like Balloon Occluded Retrograde Transvenous Obliteration (BRTO), Plug-assisted Retrograde Transvenous Obliteration (PARTO) and shunt occlusion procedures resulting in diversion of blood flow towards the portal circulation and in turn the liver. According to this investigator hypothesized that shunt occlusion improves liver volume and function along with beneficial effect on other organ systems by decreasing ammonia and improving hepatopetal flow. All patients with cirrhosis having large shunt(\>10mm) and raised ammonia levels and will be randomized to receive standard medical treatment and those receiving shunt occlusion procedures. Investigator will assess organ functions and liver regenerative potential pre and post (after 3 to 15 months) procedure.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent to participate in the study
* Age 18 to 70 years
* Cirrhotic patients with large shunts (\>10mm) and hyperammonemia (arterial ammonia \>1.5 x N)

Exclusion Criteria:

* Intractable ascites
* Hepatocellular Carcinoma
* Portal Vein Thrombosis or splenic vein thrombosis
* High risk esophageal varices
* Pregnant and lactation
* Significant heart or respiratory failure
* Active gastrointestinal bleeding
* Refusal to participate in study
Study of Effectiveness of GEMDOX in Relapsed Osteosarcoma

A retrospective observational study of the effectiveness of gemcitabine - docetaxel in patients with relapsed osteosarcoma who have been treated with HD IFO in first line treatment


Eligibility Criteria:
Inclusion Criteria:

* Age at diagnosis of high grade osteosarcoma \>= 4
* Received first line treatment with HD IFO
* Following HD IFO treatment, they have been diagnosed refractory disease and they satisfy at least one of the following criteria :

  1. Relapsed in the first 24 month following the initial diagnosis, regardless of location and resectability
  2. Lung relapsed disease with more than 2 nodules diagnosed over 24 months from the initial diagnosis
  3. Non resectable relapsed disease diagnosed over 24 months from the initial diagnosis Before or during GEMDOX treatment, eligible patients may have been subject to metastasectomy

Exclusion Criteria: none
Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects

The purpose of this study is to evaluate the safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution used four times daily in a population of adult and geriatric subjects


Eligibility Criteria:
Inclusion Criteria:

* Be at least 40 years of age
* Must have normal ocular health
* Must have history of redness relief drop use or desire to use

Exclusion Criteria:

* Must not have any ocular/systemic health problems
* Must agree to avoid disallowed medications
Botulinum Toxin A for Shoulder Pain After Stroke

Shoulder pain after stroke is a very common, causing significant morbidity disease. Subacromial and subdeltoid (SASD) bursitis are common causes of pain or disability of the shoulder joint in stroke patients. Traditional therapeutic approaches for the shoulder pain therapy including pharmacotherapy, injection therapy, physical therapy, and behavioural modification. Unfortunately, these therapy methods may not be effective in many patients and long term benefit after treatment is transient, the outcomes may also be incomplete or non-existent. Botulinum toxin A (BoNT-A) is a neurotoxin that can inhibit not only the acetylcholine at the neuromuscular junctions but also other neurotransmitters such as glutamate, substance P and calcitonin gene related peptide, all of which have been indicated in pain transmission. Despite the therapeutic benefit of BTX in alleviating painful muscle spasms, its efficacy in SASD bursitis conditions is less clear. So we perform this study to examine the efficacy of ultrasound guided SASD injection with BoNT-A in reducing refractory shoulder pain after stroke.


Eligibility Criteria:
Inclusion Criteria:

1. Stroke patients with pain around the shoulder or lateral deltoid area and deteriorated during active or passive overhead activity;
2. Neer and/or Hawkins tests (+);
3. NRS\>5 at rest;
4. Symptoms lasted for at least for 2 months and were unresponsive to analgesic medication or physical therapy for 1 month.
5. Subjects voluntarily sign the informed consent.
6. Age between 18 and 80 years old. -

Exclusion Criteria:

1. Received earlier subacromial injections of corticosteroids or botulinuim toxin in the last 6 months;
2. Shoulder fracture, glenohumeral osteoarthritis, bone tumors or osteonecrosis in plain radiographs.
3. Known allergy or sensitivity to study medication or its components.
4. Infection or dermatological condition at the injection sites.
5. Any medical condition that may put the subject at increased risk with exposure , including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might have interfered with neuromuscular function.
6. QTc criteria: QTc ≥ 450 millisecond (msec) or≥480msec for subjects with Bundle Branch Block-values based on either single electrocardiogram (ECG) values or triplicate ECG averaged QTc values obtained over a brief recording period
7. Liver function tests: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥2xULN; alkaline phosphatase and bilirubin \>1.5xULN (isolated bilirubin \>1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
8. Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function.
9. Patients with severe cognitive impairment or neurological diseases affecting the implementation or evaluation of the test, and drug-dependent patients.
10. Presence of clinically unstable severe cardiovascular, renal or respiratory disease
11. Researchers believe there are other factors unfit to participate in this study of patients.

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Fracture Healing Assessed by HR-pQCT After Administration of Calcium and Vitamin D

This study is designed as a single-blind RCT in 80 postmenopausal women to compare the effect of immediate administration of daily calcium supplementation (1000 mg calcium) or two daily dosages of calcium + vitamin D (1000 mg calcium + 880 IU vitamin D or 1000 mg calcium + 1760 IU vitamin D) to standard care (administration of vitamin D3 12 weeks after fracture) in terms of calculated bone strength based on analysis of cortical and trabecular bone parameters using HR-pQCT, fracture healing and functional outcome.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women older than 50 years who present themselves in clinic with a distal radius fracture due to a trauma.
* Patients with a stable distal radius fracture treated by cast immobilization.
* Patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical and radiographic evaluations and the prescribed rehabilitation.
* Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.

Exclusion Criteria:

* Patients who underwent surgery of the wrist or radius on a previous occasion on the same side or who need surgery this time.
* Patients with active or suspected infection such as pneumonia or complicated urinary tract infection in the last 3 months.
* Patients with malignancy or a pathological fracture in the last 12 months.
* Patients with a neuromuscular or neurosensory deficit, e.g. Parkinson's disease, which would limit the ability to assess the performance during the healing period.
* Patients with known systemic or metabolic disorders leading to progressive bone deterioration, such as: hyperthyroidism, hyperparathyroidism, chronic kidney disease with eGFR\<30 ml/min, sarcoidosis, hypercalcemia,
* Patients with an active inflammatory disease during the last year such as rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease, e.g. Crohn's disease and ulcerative colitis.
* The use of glucocorticoids during the last 12 months.
* Patients with an allergy to calcium, calcium carbonate, cholecalciferol, aspartame, citric-acid, lactose, dimethicone, methylcellulose, sorbic acid, macrogole, polyvidone, mannitol, orange flavour, natriumsaccharine, starch or sucrose.
* Patients, who as judged by the principal Investigator, are mentally incompetent or are unlikely to be compliant with the follow-up evaluation schedule.
* Patients with other severe concurrent joint involvements that can affect their outcome.
* Patients who are already selected for another trial concerning distal radius fractures.
Translation of Pritikin Program to the Community

The broad, long-term aims of this scope of work are to investigate the effects of the Pritikin Program to the general population. The study will test the effects on individuals from the community with dysfunctional lipids, blood pressure and glycemic control. To assess the effectiveness of the Pritikin Program in the community, the effects of Pritikin lifestyle intervention on overall health will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Dysfunctional lipids, blood pressure and glycemic control determined at a screening visit:

  * Triglycerides \> 150 mg/dL OR HDL \<50 in females, \<40 mg/dL in males
  * Systolic blood pressure ≥130 mmHg OR diastolic blood pressure ≥80 mmHg (or on hypertension medication)
  * HbA1c ≥5.7% or higher
* No diagnosis or treatment for cancer in the past year
* No diagnosis of mild cognitive impairment or dementia in the past year
* Ability to perform daily exercise, including aerobic activity and resistance exercise
* Non-smoker in the past year

Exclusion Criteria:

* Positive exercise stress test
Effects of Dual Task Training on Balance, Activity and Participation in Children With Cerebral Palsy

Cerebral palsy is a non progressive neurodevelopmental disorder that usually effects the muscles of the patients effecting its tone, strength and eventually ability to move. Dual tasking training incorporates more than one task at a time, it can b either physical task with movement or mental tasks. Backward walking is used to challenge the proprioception.

The study is a randomized controlled trial to assess the effects of Dual task training with and without Backward walking on balance, activity and participations on children with cerebral palsy. Study will be conducted in PSRD and Rehab care. Sample will be recruited randomly and then divided into two groups control and experimental group. Control group will receive dual task training and experimental group will receive both dual task training and backward walking. This treatment would continue for 4 weeks. Patient will be assessed both at the start and end of 4 weeks. The outcome tools for assessment of balance, activity and participation will be following: Pediatric Berg Balance Scale, Time up and Go test and Participation of daily life PODCI Questionnaire. Ethical consideration will be followed and informed consent will be taken from legal guardians.

The randomized control trail includes two groups; Control and experimental group. Control group will receive Dual task training. Dual task training incorporates cognitive and motor task. motor task like waking on balance beam is combined with visual memory tasks like pointing towards an object the therapists asks, ask the patient to collect the hanging stars while different shapes are hanging above him, name the object in the picture shown to patient. This treatment will continue for 4 weeks, 4 times a week for 40 minutes.

Experimental group will receive both Dual task training and Backward walking. with the activities mentioned above patient will be asked to walk backward with any obstacle firstly with complete physiotherapist assistance and then gradually with less assistance. Secondly patients will be asked to cover a distance of 15 m through the treatment room's hallway while holding a safety bar with the hand on the unaffected side. Third, without using a safety bar, the participants were urged to walk freely. Lastly, the participants tried to walk backwards at a reasonable pace while progressively increasing their distance travelled and speed. the duration of the treatment will be the same. The patients will be assessed first at the start of treatment and then at the end of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy who have already received a diagnosis
* Children with GMFCS Level I-II
* Children between the ages of 6 and 12

Exclusion Criteria:

* Being unable to complete the cognitive task, which involves counting back one after each number between 0 and 100
* Posing a behavioral issue that makes it challenging to engage in the study
* Being unable to walk independently
* Children with concomitant cardiac conditions
* Any musculoskeletal surgery performed during the previous six months
Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database

This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.

Non-interventional, retrospective data collection on standard treatments of haemophilia A and B patients with inhibitors in the UK.

Eligibility Criteria:
Inclusion Criteria:

* All haemophilia A or B patients with inhibitors treated with NovoSeven are included

Exclusion Criteria:

* No exclusion criteria beyond the contraindications described in the approved product information text