cyrilzakka/clinical-trials huggingface dataset:
A Real-Time Ultrasound Guided Approach For Spinal Anesthesia

Our goal was to compare the number of attempts to perform spinal anesthesia using real-time ultrasound guidance versus landmark technique in patients meeting predefined criteria for difficult spinal anesthesia.

Patients who consent to receive spinal anesthesia (as opposed to some other anesthetic technique) and who meet the inclusion/exclusion criteria for the study (given below) will be randomized on day of surgery after obtaining informed consent to either ultrasound-guided or standard spinal anesthesia technique.

A block randomization scheme with random block sizes ranging from 2-8 patients will be used. The outcomes will be recorded by a third party observer in the block room/operating room who might be a nurse or resident or clinical research fellow not directly involved with performing the block. The post procedure outcomes will also be recorded by a clinical research fellow or resident who was not directly involved with performing the block.

No sample size estimation methodology currently exists for the right-censored count data models. We expect less number of attempts in the ultrasound group a 20 % difference between the two groups which we feel is a minimum of a clinically-relevant effect. At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group,therefore we plan to recruit 40 patients in total.

The analysis will be conducted by a statistician who will be blinded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 55 or older
2. BMI more than 40
3. Scoliosis

Exclusion criterion:

1 Patients who have undergone previous Spine Surgery
Aneurysm Embolization System for Intracranial Aneurysms

The purpose of this clinical study was to evaluate the safety and efficacy of the aneurysm embolization system produced by Jiangsu Changyida Medical Technology Co., Ltd. in patients with intracranial aneurysms (including ruptured aneurysms)


Eligibility Criteria:
Inclusion Criteria:

* (1) Age ≥18 years old, and ≤75 years old, male or female; (2) There was an unruptured aneurysm or a single ruptured aneurysm requiring treatment, and the Hunt-Hess score was grade I-III; (3) The target aneurysm to be treated must have the following characteristics:

  1. sacculate;
  2. aneurysms located in anterior communicating artery, middle cerebral artery bifurcation aneurysms and basilar artery apex aneurysms;
  3. The diameter of the aneurysm is in accordance with the instruction manual of the aneurysm embolization system for treatment;
  4. Aneurysm diameter from 2mm to 15mm;
  5. Tumor body/neck (D/N) ratio ≥1;
  6. Tumor neck ≥4mm or tumor body/neck (D/N) ratio \< 2; (4) The target aneurysm is suitable for aneurysm embolization system treatment; (5) The subject is able to understand the purpose of the study, demonstrates sufficient adherence to the study protocol, and is able and willing to sign the informed consent.

Exclusion Criteria:

* (1) Patients with aneurysms who are not suitable for endovascular therapy; (2) The microcatheter could not reach the target aneurysm of the patient after being shaped, and could not be treated with research instruments; (3) There are risk factors for ischemic stroke, or ischemic symptoms that have occurred within the last 30 days, such as transient ischemic attack, minor stroke, or progressive stroke; (4) The presence of cerebrovascular, cardiovascular or neurological diseases that cause instability of neurological symptoms; (5) mRS≥ 2 before the onset of symptoms or rupture of the aneurysm (if applicable); (6) Patients with intracranial hypertension or other intracranial hematoma within 90 days requiring elective surgery; (7) Patients who are being treated with anticoagulants or who currently have malignant diseases of the blood system, coagulation diseases or hemoglobinopathy; (8) Patients who are allergic to any component of the research instrument, surgical material or drugs used during the operation and cannot be effectively treated; (9) Patients whose life expectancy is less than 2 years due to other diseases or conditions (other than intracranial aneurysms); (10) Patients with mental disorders; (11) Women who are pregnant or breastfeeding, or who have a birth plan in the next 3 months; (12) Patients who are participating in any other drug or medical device clinical trial, or who may participate in any other drug or medical device clinical trial after enrollment in this clinical trial; (13) The investigator determines that there are other conditions that are not suitable for participation in this clinical trial.
Postoperative Balloninflation After Evacuation of cSDH

In this prospective, randomized, multicenter trial shall patients with chronic subdural hematoma (cSDH) recruited, who were surgically treated. Initially, we would divide the patients randomized into two groups: Patients with supervised blow-maneuver and without. After surgical treatment of cSDH with insertion of a subdural drain, one group would perform a supervised blow maneuver ("Valsalva maneuver") every hour for five minutes from 10:00 to 20:00. In the other group, the standard care would be performed. The subdural drain would be explanted 2days after operation and a postoperative CT scan would routinely be performed. After hospital discharge, the patient would be rechecked in an ambulant setting and would receive CT scan as clinical standard. Recurrence of hematoma is defined as recurrent hematoma which should be reoperated. After 3 and 6 months we would evaluate the outcome of patients.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* surgically treated cSDH
* patients with an operatively implanted subdural drainage

Exclusion Criteria:

* age under 18 years
* Admission in critical clinical state, e.g. already to light unresponsive pupils for about 2 hours
* conservative treatment of cSDH
* patients without an operatively implanted subdural drainage
* patient cannot be consented
* participation in other clinical trials
Targeted Ballet Class for Cerebral Palsy

This study aims to investigate the effect of the targeted ballet dance on participants with cerebral palsy

Cerebral palsy (CP) is the most common motor disorder in childhood, with a prevalence of 3.1 to 3.6 cases per 1000 living births in the United States. The motor signs of CP include abnormal muscle tone and motor control, preventing individuals with CP from participating in normal daily activity. The most common type of CP is spastic CP, in which spasticity is present and range of motion in the joints is reduced. Physical therapy is one fundamental method of rehabilitation that attempts to recover motor function via exercises, while the effects of physical therapy are still elusive due to the lack of comprehensive evidence. This study uses a targeted ballet class to promote balance, increased range of motion, and reduced spasticity. The combination of qualitative clinical measures and quantitative assessment spasticity aims to demonstrate the benefits brought by the dance class.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with spastic cerebral palsy
* is between 3 to 64 years old
* have no uncorrected vision
* have no other neuromuscular or musculoskeletal condition
* have not had surgical procedures within six months of enrollment in the study
* participate in stable school and/or private physical therapy with a frequency no greater than one session per week
* have no changes in medication for the last six months
* have the ability to pay attention and follow three-step directions
* be medically stable, (8) have no other concurrent illness
* have not received any Botox treatment within three months previous to the initiation of the study, and have Gross Motor System Classification Scale (GMFCS) I-IV (NOT V).

Exclusion Criteria:

* Not meeting ALL of the criteria
Activin A and Inhibin A in Predicting Outcome of Pregnancies of Unknown Location After Assisted Reproductive Technology

The purpose of this study is to determine the predictive value of a single serum determination of activin A and inhibin A for the prognosis of ectopic pregnancy after in Vitro Fertilization (IVF) cycles, in both native and donated oocytes.

Ectopic pregnancy (EP) is one of the most common pathologies seen in emergency gynaecology practice. Early diagnostic of this situation is a clinical objective because it remains an important cause of maternal morbidity and mortality worldwide. Currently, transvaginal ultrasound scan (TVS) allow ascertain the location of the pregnancy. However, the diagnosis of EP is complicated by a nonspecific clinical presentation and the inconclusive results in some cases of transvaginal ultrasound at first presentation. For this reason several biomarkers have been investigated to accurately detect the establishment of pregnancy and predict its outcome as early as possible.

These biomarkers include: markers of abnormal embryo/trophoblast growth (β-subunit of HCG, Activin A, etc), markers of abnormal corpus luteum function (progesterone, inhibin A, etc), markers of a growing pregnancy in the Fallopian tube (creatine kinase, vascular endothelial growth factor, etc), markers of inflammation and peritoneal irritation (cancer antigen 125, interleukin-6, etc), and uterine markers of normal implantation (leukaemia inhibitory factor and glycodelin). Β-HCG and progesterone are usually used in clinical practice and activin A and inhibin A have recently shown promising results.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pregnancy of unknown location (PUL) diagnosed 22 - 27 days after oocyte retrieval, at first ultrasound routine control (A "pregnancy of unknown location" (PUL) is a term used to classify a women with a positive pregnancy test and an empty uterus with no signs of an intrauterine or extrauterine pregnancy on a transvaginal ultrasound scan.)
* Patients with Intrauterine pregnancy : Viable intrauterine pregnancy (IUP) An intrauterine gestational sac containing a fetal pole with visible cardiac activity
* Patients with Ectopic pregnancy (Tubal ectopic pregnancy): An empty endometrial cavity with: (i) an inhomogeneous adnexal mass or (ii) an empty extrauterine gestational sac seen as hyperechoic ring or (iii) an extrauterine gestational sac with a yolk sac and/or fetal pole with or without cardiac activity
Impact of Helicobacter Pylori Infection on Prolactin Levels in Reproductive-Age Women to Determine Whether H. Pylori Infection is Associated with Elevated Prolactin Levels and Assess the Clinical Implications

The research is a cross-sectional observational study conducted at Assiut University Hospital. It will involve 75 women aged 18-45 with confirmed H. pylori infection. The study will measure serum prolactin levels and H. pylori infection status through stool antigen tests. The primary outcome is comparing prolactin levels between H. pylori-positive and negative women. Secondary outcomes include analyzing correlations with clinical symptoms and demographic factors.

Study Design and Setting Cross-sectional observational study

Conducted at Assiut University Hospital

Sample size: 75 women

Participants Inclusion criteria: Women aged 18-45, confirmed H. pylori infection, reproductive age

Exclusion criteria: Recent antibiotic or PPI use, endocrine disorders, chronic illnesses affecting prolactin

Data Collection Participant recruitment from outpatient clinics

Laboratory assessments:

Stool antigen test for H. pylori using ELISA method

Serum prolactin measurement via chemiluminescent immunoassay

Questionnaire for demographic information and medical history

Outcome Measures Primary: Serum prolactin levels in H. pylori-positive vs. negative women

Secondary: Correlation with clinical symptoms and demographic factors

Analysis The study will compare prolactin levels between H. pylori-positive and negative groups, analyze correlations with symptoms, and assess the influence of demographic factors on prolactin levels and H. pylori prevalence.

Eligibility Criteria:
Inclusion Criteria:

- 1. Age Range: Women aged 18 to 45 years. 2. Diagnosis of H. pylori Infection: Participants must have a confirmed diagnosis of H. pylori infection through non-invasive methods such as stool antigen tests or breath tests and IgM serum.

3. Reproductive Age: Women must be within reproductive age and not currently pregnant or breastfeeding

Exclusion Criteria:

* 1. Recent Antibiotic Use: Individuals who have taken antibiotics within the last month will be excluded to avoid interference with H. pylori detection.

  2. Use of Proton Pump Inhibitors (PPIs): Patients using PPIs or other medications that affect gastric acid secretion within the last month will be excluded.

  3. Endocrine Disorders: Women with known endocrine disorders such as hyperprolactinemia from other causes will be excluded.

  4. Chronic Illnesses: Individuals with chronic illnesses that could affect prolactin levels (e.g., renal failure, liver disease) will also be excluded.
Ultrasound Guided Rectus Sheath Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Open Total Abdominal Hysterectomy

This study aims to compare the effectiveness and safety of ultrasound-guided rectus sheath block versus intrathecal morphine for postoperative analgesia in patients undergoing open total abdominal hysterectomy.

Effective postoperative analgesia is crucial for enhancing recovery and patient satisfaction following major surgical procedures, such as total abdominal hysterectomy (TAH).

Rectus sheath block (RSB), an ultrasound-guided regional anesthesia technique, involves the injection of local anesthetic into the rectus sheath, providing analgesia to the anterior abdominal wall. RSB is used to block the sensory nerves of the anterior abdominal wall and thereby contributing to pain relief after lower abdominal surgeries.

Intrathecal morphine (ITM) provides a highly effective method of analgesia by delivering the medication directly into the cerebrospinal fluid (CSF).

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 65 years old.
* American Society of Anesthesiologists (ASA) physical status (I -II).
* Patients undergoing open total abdominal hysterectomy.

Exclusion Criteria:

* Hepatic, renal, or cardiac disease.
* Any known allergy to local anesthetic.
* Physical or mental conditions which may vague measuring postoperative pain following surgery.
* History of chronic use of analgesic as nonsteroidal anti-inflammatory drugs (NSAIDs) or central nervous system (CNS) depressants as antiepileptic, and bleeding disorders.
Epidural Stimulation After Neurologic Damage

This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.

Epidural spinal cord stimulation for the purpose of facilitating volitional movement is a new and novel neuromodulatory treatment. Epidural SCS has a long history of use for chronic pain with established medical device platforms. The purpose of this study is to investigate and establish the use of SCS for volitional movement. Specifically, establishing the disinhibitory effect of SCS in a greater population with inherent greater variability.

In addition to establishing the disinhibitory effect of SCS for cSCI, our study attempts to explore the parameter space of the spinal cord stimulator platforms in order to optimize stimulation settings for patients through the creation of a clinical decision support system (CDSS). Preliminary evidence suggests benefit to autonomic function, and this study also begins to explore the effects of SCS on cardiovascular function, urinary function, psychiatric outcomes, and quality of life, which all offer significant potential for patients suffering from chronic spinal cord injury.

Eligibility Criteria:
Inclusion Criteria:

* 22 years of age or older
* Able to undergo the informed consent/assent process
* Stable, motor-complete paraplegia
* Discrete spinal cord injury between C6 and T10
* ASIA A or B Spinal Cord Injury Classification
* Medically stable in the judgement of the principal investigator
* Intact segmental reflexes below the lesion of injury
* Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation
* Willing to attend all scheduled appointments

Exclusion Criteria:

* Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues)
* Inability to withhold antiplatelet/anticoagulation agents perioperatively
* Significant dysautonomia that would prohibit rehabilitation or assisted standing or any history of CVA or MI associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP \< 50 or \>200.
* Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator
* Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the principal investigator
* Clinically significant mental illness in the judgement of the principal investigator
* Botulinum toxin injections in the previous 6 months
* Volitional movements present during EMG testing in bilateral lower extremities
* Unhealed spinal fracture
* Presence of significant contracture
* Presence of pressure ulcers
* Recurrent urinary tract infection refractory to antibiotics
* Current Pregnancy
Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer

This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a single intravenous dose of TS23 in healthy adults.

This is a first-in-human, Phase 1 study of the safety, pharmacokinetics and pharmacodynamics of TS23 in healthy male volunteers.TS23 is a monoclonal antibody that inactivates alpha 2-antiplasmin. Four dose cohorts of six subjects will be studied in a single ascending dose trial at one clinical center.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Healthy males age 18 years to 60 years of age
* Body mass index ≥ 20 and ≤ 33 kg/m squared

Exclusion Criteria:

* Known allergies or hypersensitivities to blood products or derivatives or therapeutic proteins or product excipients or components of CHO cells
* Current alcohol or drug abuse or history of alcohol or drug abuse
* Participation in any trial with an investigational drug within 90 days prior to dosing
* Blood donation of more than 500 mL of blood within 90 days prior to dosing
* Any history of a bleeding or thrombotic disorder
* Any history of significant cardiac, pulmonary, renal, hepatic, neurologic, or immunologic disorder
* Over-the-counter medications, dietary supplements and herbal products (except a daily vitamin) within 14 days of drug administration or during the study
* No prescription medication for at least 14 days or 5-half-lives, whichever is longer, prior to study drug administration.
* Use of anticoagulants, fibrinolytic agents or non-steroidal anti-inflammatory medicines (except aspirin doses of 82 mg per day or less) for 2 weeks prior to and during the study
* Known hereditary fructosemia (due to sorbitol in the formulation)
* Any previous or current monoclonal antibody therapy
* History of trauma or surgery within the past 60 days or planned surgery within 30 days
* Abnormal baseline laboratory values or any laboratory values deemed clinically significant by the Investigator
* Recent history of head trauma in last 30 days prior to receiving TS23
* Unwillingness or inability to avoid contact sports or other activities with more than a small risk of head or facial trauma within 30 days of receiving TS23
* History of or risk of falls (e.g., due to dementia, frailty, etc.)
* Sexually active subjects must agree to use a reliable method of birth control (abstinence, condoms, vasectomy) and to not donate sperm for 3 months after receiving TS23
Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome

The purpose of this study is to test the efficacy and safety of a traditional Chinese medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome (IBS-D).

Participants: The sample size of this trial is 118, to test an odds ratio of 3.5 at a significance of 0.05 and power of 0.8.

Intervention: Tong-Xie-Yao-Fang versus placebo Data collection: Standard operation procedure will be developed for how to interviewing the participants, how to use the IBS diary, how to enter the data into the electronic case report forms.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed as IBS according to the Rome III criteria;
* Diarrhea was present for at least 75% of the time;
* With a TCM differentiation as "liver stagnation and spleen defficiency"
* Had a colonoscopy within a year to rule out other bowel diseases.

Exclusion Criteria:

* Organic gastrointestinal disease, such as colorectal cancer, inflammatory bowel disease, advanced colonic polyp;
* Had gastrointestinal surgery within a year;
* Used durgs that affect gastrointestinal motility;
* Had psychological disorder;
* Serious disease in other system, which may bias the outcome measures.
Treatment of Chronic Mountain Sickness

This study aims to assess the effect of two drugs for the treatment of chronic mountain sickness in highlanders.

About 100 million individuals reside at high altitude (\>2500m) worldwide, with the largest populations of highlanders being found in South America (Andean), central Asia (Tibetan and Sherpa) and East Africa (Ethiopian). Despite unique adaptations to hypoxia in these populations, chronic mountain sickness (CMS) is a clinical syndrome which is observed in 5-33% of individuals residing permanently at high altitude.Several pharmacological approaches have been proposed in the treatment of EE and CMS. However, few studies show sufficient clinical evidence for safety and efficacy in CMS treatment and most highlanders with CMS remain untreated. The present project aims to better characterize chronic hypoxic responses in highlanders and to evaluate the interest of acetazolamide and statins as potential treatments for chronic mountain sickness.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 18 and 55 yrs
* Body mass index \<30kg/m²
* Born at \>3500 m, living for \>3 years at the local high altitude
* No diagnosis of cardiorespiratory, metabolic or neurological diseases
* No drug intake
* No smoker
* Chronic mountain sickness score ≥6

Exclusion Criteria:

* Diagnosis of cardiorespiratory, metabolic and neurological diseases
* Systolic \> 130 mmHg and/or diastolic \> 85 mmHg blood pressure
* Drug intake
* Smoker
* Chronic mountain sickness score \<6