cyrilzakka/clinical-trials huggingface dataset:
Stellate Ganglion Block to Reduce Hot Flushes

To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

Hot flushes are the most common symptom of menopause for which postmenopausal (PMP) women seek medical help, in 20% of PMP women hot flushes can persist for up to 15 years.

A possible treatment for hot flushes is stellate ganglion block (SGB), used as a means to interrupt parts of the sympathetic nervous system involved in temperature regulation.

Single centre randomized double blind placebo controlled intervention study Study period of 6 months in which patients will fill out on set time points 5 questionnaires regarding quality of life and keep a diary on hot flush frequency and severity during1 week on the same time points.

Study population:

Postmenopausal women aged 30-70 years old with no other causes of flushing present. Intervention (if applicable) Intervention: Stellate ganglion block versus sham procedure

Follow up with questionnaires during 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age: 30-70 years
* Mean daily flush frequency of 10 or more and a hot flush score of 15 or more
* Absence of any non-menopausal cause of flushing
* Post-menopause amenorrhea for more than 1 year in healthy postmenopausal women
* In case of breast cancer or ovariectomy induced menopause: ovariectomy for \> 6 months. Adjuvant therapy with estrogen-receptor blocker or an aromatase inhibitor.

Exclusion Criteria:

* Use of medication that affects flushing:oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteïniserend hormone releasing hormones receptor antagonist
* Receiving chemotherapy of radiotherapy
* Active psychiatric disease
* Active concurrent disease
* Allergic reactions against local anesthetics of the 'amide' type or contrast media.
ROSCAP: Reduction of Smoking in Cardiac Patients Study

Background. The ROSCAP Study was a randomized controlled trial in heart disease patients to test the effect of a smoking reduction intervention on cigarettes per day (cpd) and biochemical and clinical indicators of tobacco exposure. .


Eligibility Criteria:
Inclusion Criteria:

* smoked at least 15 cigarettes per day and had one of 11 cardiovascular disorders: history of myocardial infarction, coronary artery bypass surgery, angioplasty, stent placement, thrombolytic therapy, angina, arrhythmia, a history of cardiac arrest, greater than 50% coronary artery stenosis by angiography, ischemia on exercise tolerance testing or congestive heart failure, required to confirm that they were unwilling or uninterested in setting a stop smoking date in the next 30 days.

Exclusion Criteria:

* 1) unstable angina within the past 2 weeks, 2) unstable psychiatric or substance use disorders or 3) contraindications to nicotine replacement therapy (including pregnancy or intention to become pregnant)
Cosmetic Outcomes and Patient Satisfaction After Facial Laceration Repair in the Emergency Department

Facial lacerations are commonly treated in the emergency department. The nature of the injury leads to a great deal of concern about the long-term cosmetic appearance of the wounds.

Research Questions

1. What is the association between wound characteristics, wound management in the ED, patient satisfaction in the ED, and patient-rated cosmetic appearance of sutured wounds?
2. Is there a difference noted among ED providers with different levels of training?
3. Is there an association between initial satisfaction scores and wound outcome?
4. Is there an association between short term and long term wound scores?

Design This is a non-randomized, prospective, observational study of patients who present to the ED seeking treatment for facial laceration repair.


Eligibility Criteria:
Inclusion Criteria:

* Families presenting to the ED for repair of facial laceration will be approached for study inclusion if:

  * Their child seeking treatment is less than 18 years of age
  * The laceration was sustained less than 12 hours prior to presentation to Children's ED
  * They speak English

Exclusion Criteria:

* Families presenting to the ED for repair of facial laceration will be excluded from study participation if they:

  * Are medically complex children
  * Have a history of pre-existing coagulopathy or collagen vascular disease
  * Have a history of immunodeficiency or diabetes mellitus
  * Are suspected of non-accidental trauma
  * Have wounds that could be approximated by tissue adhesives
  * Have animal or human bites
  * Have gross contamination
  * Have puncture wounds
  * Have lacerations of tendon/nerve/cartilage
  * Have scalp lacerations
  * Do not speak English
Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery

The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.


Eligibility Criteria:
Inclusion Criteria:

* Requires bilateral myringotomy and tympanostomy tube insertion;
* Provides informed consent (parent/legal guardian);
* Signs assent form where applicable (subject);
* Accompanied by parent/legal guardian at each visit;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Menarcheal females;
* Current or recent history of any disease which, in the opinion of the Principal Investigator, may place the subject at risk or interfere with study;
* Use of excluded medications within one week prior to surgery and for the duration of the study;
* Requires another surgical procedure in addition to the myringotomy;
* Clinically relevant otic condition which, in the opinion of the Principal Investigator, would preclude the safe administration of the study medication;
* Participation in any other investigational study within 30 days before entry into this study or along with this study;
* Known or suspected allergy or hypersensitivity to any active or inactive ingredient in the test article;
* Other protocol-defined exclusion criteria may apply.
Magnetic Resonance Imaging Study of Acute Pancreatitis

To quantitatively analyze the T2\* values of the head, body, and tail of normal pancreas, and observe the value of GRE T2\*-weighted MRI in the diagnosis of acute pancreatitis and the relationship between the T2\* value and the severity of AP.

1. We design a prospective study about "Magetic Resonance Imaging Study of Acute Pancreatitis".
2. We apply for an account and register our study on the clinicalTrials.
3. In patients with acute pancreatitis, imaging is recommended to confirm the clinical diagnosis, investigate the etiology, and grade the severity of the disease . MR had the excellent resolution of soft tissue，and it has earned an ever more important role in the diagnosis of AP. With the continuous development of MR scanning techniques, the sequence of a multi-echo gradient recalled echo (GRE) T2\*-weighted imaging (T2\*WI), which acquires a spin echo signal, T2\* relaxation acquires a gradient echo signal, is a relatively new MRI technique. The sequence of a GRE T2\*WI requires high uniformity of the magnetic field, plus it can provide the T2\* value, which can indirectly reflect changes in tissue biochemical components, thus it can be used for the early diagnosis quantitative diagnosis of some diseases .
4. This calculation process for T2\* value is completed using post-processing software on the workstation(Advantage workstation 4.4; GE Halthcare) directly after scanning.
5. AP is a process of inflammation diffusion, in which cell edema will lead to hydrogen proton increase. In the inflammatory exudation process, T2\* value will change. So we conduct our research. In this study, we will observe pancreas in the normal pancreas and AP, and discuss the relationship between T2\* value and that of AP graded by the MR severity index (MRSI) and Acute Physiology And Chronic Healthy Evaluation II (APACHE II) scores.
6. However, until now, there is no research on the sequence applied in the patients with AP.

Eligibility Criteria:
Inclusion Criteria:

* acute onset of abdominal pain;
* pancreatitis at first onset;
* three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and
* abdominal MR examination.

Exclusion Criteria:

* inability to cooperate when MR imaging was performed;
* a history of chronic pancreatitis;
* AP due to pancreatic carcinoma;
* hypoproteinemia;
* with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ;
* with iron deposition disorder (e.g. diabetes or blood system diseases).
Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics

The study objective was to determine whether liver injury develops in alcoholic patients who ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3 consecutive days and remain in the facility an additional 2 days for monitoring. The primary measures were aminotransferase measures taken at baseline and Days 2-5. We hypothesized that there would be no difference in aminotransferase measures between the acetaminophen and placebo study groups.


Eligibility Criteria:
Inclusion Criteria

Any patient, regardless of gender or ethnicity, who was:

1. 18 years or older
2. admitted to one of the two controlled access alcohol detoxification centers with a positive BAL at the time of admittance
3. signed a written informed consent form.

Patients were excluded from the study at baseline if any of the following were present:

1. serum acetaminophen level greater than 20 mcg/ml
2. serum AST or ALT levels greater than 200 IU/L
3. INR greater than 1.5
4. if female, positive for beta-subunit of chorionic gonadotropin
5. clinically intoxicated, psychiatrically impaired or unable to give informed consent
6. known hypersensitivity to acetaminophen
7. history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment
8. currently enrolled in another trial or had been enrolled in another trial in the preceding three months.
Acute Effects of Juice Consumption With Biofunctional Compounds and Probiotics on Glucose Metabolism

This study investigated the short-term effects of fruit juice enriched with Vitamin D3 or n-3 PUFA or probiotics and the combination of the three ingredients on glucose metabolism.

This study aimed to 1. Determine the glycemic index and glycemic load of mixed fruit juice (pomegranate, grape, apple, and orange) enriched with Vitamin D3 or n-3 PUFA or probiotics, and the combination of the three bio-functional ingredients, compared to regular mixed fruit juice and the reference food (D-glucose), and 2.Examine the short-term effects of the five mixed fruit juices on postprandial blood glucose and salivary insulin responses, blood pressure, and subjective appetite, in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-smoking
* Non-diabetic men and women
* Body mass index between 18.5 and 25 kg.m2

Exclusion Criteria:

* Severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* Gastrointestinal disorders
* Pregnancy
* Lactation
* Competitive sports
* Alcohol abuse
* Drug dependency
Cost-effectiveness of PCI With Taxus vs CABG - 5 Years FUP

The objective of the present study is to analyze the cost-effectiveness of percutaneous coronary intervention (PCI) using TAXUS stents compared to the costs of coronary artery bypass surgery (CABG) in patients with multivessel coronary artery disease (CAD) in the first 5 years and then 10 years after intervention. Multivessel PCI or CABG was performed in 114 or 93 patients, respectively. Clinical outcomes, in terms of incidence of acute myocardial infarction (AMI), all-cause death, target vessel revascularization (TVR) and stroke, resource use and costs are analyzed prospectively over a 5 and 10-year follow-up (FUP) period. Overall costs consist of the baseline costs of the index procedure (PCI or CABG), clinical and angiographic procedure-related treatments during the entire FUP. The primary endpoint is cost-effectiveness and clinical effectiveness, defined as the reduction of the composite of major adverse cardiac and cerebrovascular events (MACCE).


Eligibility Criteria:
Inclusion Criteria:

* two or three-vessel disease requiring percutaneous or surgical multivessel intervention with the aim of complete revascularization
* age \> 18 years
* clinical symptoms (stable or unstable angina) or signs of myocardial ischemia
* ≥ 50% diameter stenosis of each lesion

Exclusion Criteria:

* acute myocardial infarction (\< 48 h);
* contraindications to clopidogrel, aspirin, heparin and taxol;
* pregnancy or lack of protection against pregnancy or breast-feeding during the study;
* hemorrhagic diathesis and platelet count \<100.000/ml3
China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Chinese participants with relapsed/refractory multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria.
* Previously treated with at least 1 prior line of multiple myeloma (MM) therapy and must have documented disease progression during or after their most recent therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Must have at least 1 aspect of measurable disease, defined as one of the following;

  1. Urine M-protein excretion \>=200 mg per 24-hour, or
  2. Serum M-protein concentration \>=0.5 grams per deciliter (g/dL), or
  3. Serum free light chain (FLC) assay: involved FLC level \>=10 mg per dL (\>=100 mg per liter) and an abnormal serum free light chain ratio (\<0.26 or \>1.65).
* All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\] version 5.0) must be \<=Grade 1 at the time of enrollment, except for alopecia.
* Adequate organ function

Exclusion Criteria:

* Intolerant to daratumumab.
* Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment).
* Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m\^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed.
* Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
* Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy.
* Prior allogenic stem cell transplant.
* Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies.
* Corneal epithelial disease
Quick Diagnostic Program for Head and Neck Cancer

Head and neck cancer would be suitable for quick diagnostic programs because their initial symptoms are easy detectable and the curation rates in the initial stages are very high.

Actually the stages at diagnosis are about 30% in initial stages and 70% in advanced stages.

The hypothesis of this study is that a program for quick referral of patients with symptoms of head and neck cancer would help early diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* patients with symptoms of head and neck cancer in the Hospital reference area

Exclusion Criteria:

* Patients already diagnosed when refered to Hospital
A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs

This is a phase II proof-of-concept trial study to assess the safety and efficacy of UB-421 monotherapy plus chidamide in changing the latent HIV reservoir among ART-treated HIV-1 adults with stably viral suppression who undergo ART interruption.


Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 sero-positive, with documented HIV-1 infection by official, signed, written history
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 20 years or older.
3. No breastfeeding or pregnancy for women.
4. Have been receiving ART for more than 3 years by screening visit 1 (SV1).
5. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception
6. Subjects must sign the informed consent before undergoing any study procedures.

Exclusion Criteria:

1. Subjects with active systemic infections, except for HIV-1
2. Any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug.
3. Current receiving treatment regimen for hepatitis B, hepatitis C or latent tuberculosis
4. Any alcohol or illicit drug use
5. Receipt of any other investigational study agent(s) within 90 days before SV2.
6. Currently on the treatment for diabetes.
Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure

Researchers are trying to assess how accurately and safely NIRS non-invasive monitoring can detect changes in intracranial pressure to determine if this noninvasive device can be used instead of invasive monitoring with Licox in the future.


Eligibility Criteria:
Inclusion:

* Subjects with acute brain injury who are age ≥ 18
* Glasgow coma scale score (GCS) ≤ 8
* Neuroimaging concerning for ICP crises, or have active ICP treatment
* Have Licox Brain Tissue Oxygen monitor placed as standard of care treatment

Exclusion:

* CNS infection
* Bleeding diathesis or thrombocytopenia \< 50,000 platelets
* Subjects with subdural hematomas who have had surgical decompression and bone flap removal
Efficacy, Safety and Tolerability of DNK333 (25 mg Bid) in Women With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

The purpose of this study is to evaluate the efficacy of DNK333 compared to placebo for relieving symptoms of IBS-D in female patients.


Eligibility Criteria:
Inclusion criteria:

* Women of 18 - 65 years of age with IBS-D as defined by the Rome II criteria.
* The Rome II criteria is a system used for diagnosing functional gastrointestinal disorders such as irritable bowel syndrome. It involves completing of a questionnaire about gastrointestinal symptoms.
* Patients who are 50 years of age and older must have had a colonoscopy OR a flexible sigmoidoscopy plus a double-contrast barium enema within the past 5 years, which demonstrated no clinically significant findings.
* Clinically significant findings may include but are not limited to malignant tumors, multiple (≥3) or advanced adenomas, inflammatory bowel disease, diverticulitis, ischaemic colitis, lymphocytic colitis, or collagenous colitis.
* Patients must report ≥ 3 days with IBS-related abdominal pain/discomfort plus at least 3 days of 2 or more of the following events during the baseline period:
* ≥ 3 bowel movements/day
* Bowel urgency
* Loose or watery stool

Exclusion Criteria:

* Patients who answer "yes" to either or both of the two weekly satisfaction questions during the baseline period. The questions are: (1) Over the past week did you have satisfactory relief of your IBS-related abdominal pain/discomfort? (2) Over the last week did you have satisfactory relief of your overall IBS-D symptoms?
* Patients with hard or lumpy stools for more than one day during the baseline period.
* Lactose intolerant patients relieved on a lactose free diet.
* Use of antidepressants (tricyclic, SSRI etc), opioid analgesic drugs or drugs specifically affecting bowel motility during the course of the trial.
* Women of child-bearing potential who do not use an acceptable methods of contraception.
* Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply.
Pediatric Aquatic Occupational Therapy for Children With Sensory Processing Challenges

Children with sensory processing challenges participated in an 8-week play-based aquatic program addressing goals on behavior, sensory, and participation. It is expected that after the 8-week group, the child's goals will improve demonstrating an effective intervention to address sensory difficulties.

This study examined the effectiveness of an aquatic OT program for children with sensory processing difficulties to develop water readiness skills and improve sensory, behavior, and engagement goals. Six groups of children with deficits in various sensory systems participated in an 8-week aquatic group led by an occupational therapist and occupational therapy students. Each week consisted of a 45-minute aquatic group with a 5 min warmup on land, 30 mins of aquatic activities addressing the sensory system of the week, and 10 mins addressing a social activity with peers. Goals were developed and assessed via the Goal Attainment Scale (GAS). Parents of the participants were given the Sensory Processing Measure (SPM-2) before beginning. As a result of participating in the aquatic OT intervention, percentage of goals achieved will be analyzed. It is expected that this program proves to be beneficial and therefore aquatic OT shows potential for improving sensory processing skills, behavior, and social participation with peers.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be ages 4-9 years old
* have an identified sensory processing problem as related on the SPM assessment
* able to maintain head, neck, and trunk control
* able to follow 1-2 step directions

Exclusion Criteria:

* Participants younger than 4 years old and older than 9 years old
* requires lift to get in the water
* difficulty with following 1-step directions