cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg

Study to evaluate the overall performance of the Zalviso System™ (sufentanil sublingual tablet system) 15 mcg

320 adult postoperative in-patients, who met all study entry requirements, and were expected to require opioid analgesia for at least 24 hours, and up to 72 hours, after surgery were enrolled. Patients used the Zalviso™ (sufentanil sublingual tablet system) 15 mcg to self-administer a tablet of study drug as needed for pain. The System was evaluated for usability and functionality for up to 72 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients who were 18 years of age or older.
2. Patients who were scheduled to undergo surgery under general or spinal anesthesia that does not include intrathecal opioids during the operation.
3. Patients classified as American Society of Anesthesiologists (ASA) class I - III (Appendix I).
4. Female patients of childbearing potential must have been using an effective method of birth control at the time of screening visit and for 30 days following the end of the study period. Acceptable methods of birth control included oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-child bearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for \> 1 year, was specified. Patients using hormonal forms of contraception were also willing to use a barrier method of contraception from screening through 30 days following the study period.
5. Post-surgical patients who had been admitted to the PACU, and were expected to have acute pain requiring opioids for 24 - 72 hours after surgery.

Exclusion Criteria:

1. Patients who had taken an opioid for more than 30 consecutive days, at a daily dose of 15 mg or more of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
2. Patients who were currently taking monoamine oxidase inhibitors (MAOIs) or had taken MAOIs within 14 days of the first dose of study drug.
3. Patients with current sleep apnea that had been documented by a sleep laboratory study or were on home continuous positive airway pressure (CPAP).
4. Patients with an allergy or hypersensitivity to opioids.
5. Patients who were currently taking monoamine oxidase inhibitors (MAOIs) or had taken MAOIs within 14 days of the first dose of study drug.
6. Patients with current sleep apnea that had been documented by a sleep laboratory study or were on home continuous positive airway pressure (CPAP).
7. Patients who were receiving oxygen therapy at the time of screening.
Hidradenitis Suppurativa (HS) Tunneling Wounds

The purpose of this study is to look at the change in the microbiome (bacterial composition) of an HS tunneling wound and examine if treatment with an antibiofilm surfactant wound gel (ABWG) (a topical medication that will fight bacteria attached to the surface of those tunnels) changes the bacterial composition of the wounds.


Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 years old and older
2. Have diagnosis of HS confirmed by a dermatologist
3. Have at least one HS related tunneling wound that is at least 2 centimeters in length
4. Able to provide informed consent

Exclusion Criteria:

1. Individuals who are not yet adults
2. Women known to be pregnant
3. Prisoners
4. Subjects, who in the opinion of the PI, cannot comply with home application of the treatment.
A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers

The purpose of this study is to investigate safety and toleration of single oral doses as well as the time course of PF-04418948 concentration in the blood following dosing by oral solution.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males.
Representation of the Body for Patients With Cancer

The project aims to understand better how patients live the event of cancer and live its consequences on their bodily representations. In the study, the dynamic of the body image is not restricted to appearance but include sensations and visions of the inner body, what explains the choice of peritoneal cancer, and the treatment by cytoreductive surgery and HIPEC.

The three objectives of the study are:

* identifying the impact of the representations of the treated body on the psychological strategies to cope with the disease, the bodily changes and the prospects of life;
* making explicit the positive or negative impacts of these representations on the relationship between patients and health professionals (easing factors, misunderstandings, negotiations, etc.);
* associating the health professionals with the study in its course and evaluation in order to elaborate a methodological collaborative approach between patients, health professionals and researchers in social sciences.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible to treatment of cancer by cytoreductive surgery and HIPEC
* Primary (pseudomyxoma, mesothelioma) and secondary (colorectal, gastric, ovarian) peritoneal cancer
* Free consent
* Male or Female
* Age \> 18 years
* Affiliate to social security

Exclusion Criteria:

* Age \< 18 years, no french speaking
* Cerebrals metastasis
* Psychiatrics diseases
Effect of Different Water Injection Temperatures on the Safety and Comfort of Patients Undergoing Ultrasound Endoscopy of Small Probes Under Intravenous Anesthesia

Small probe endoscopy is currently the best way to diagnose submucosal lesions of the digestive tract. Ultrasonic endoscopy of small probes requires filling the probe and the air in the lumen with water to eliminate gas. Water injection may cause patients with nausea and vomiting, choking cough, abdominal pain, bloating and other uncomfortable symptoms, and in severe cases, it may cause adverse consequences such as breath holding, arrhythmia, and increased blood pressure. At present, some studies have improved patient discomfort by changing the water injection method and developing new acoustic media during the ultrasonic endoscopy of small probes. At present, there are no studies on the impact of different water injection temperatures on the safety and comfort of patients undergoing small probe ultrasound endoscopy under intravenous anesthesia.

In order to improve patient comfort and cooperation, the vast majority of patients currently undergo ultrasound endoscopy under intravenous anesthesia. Under the action of anesthesia and sedative drugs, the patient's thermoregulation center is inhibited, and the change of external temperature is often more obvious to the patient's hemodynamics. Previous studies have found that the temperature of ingested water has an effect on human hemodynamics, digestive tract peristalsis, and visceral body temperature receptors. Injection of relatively low temperature water may reduce the patient's cardiopulmonary load, delay gastrointestinal motility, and shorten the duration of examination; Injecting room or center temperature water may reduce patient coldness and improve patient comfort. Therefore, it is interesting to explore the effects of different water injection temperatures on the safety and comfort of patients with small probe ultrasound endoscopy under intravenous anesthesia, and aim to identify an optimal water injection temperature that can ensure the safety of patient examination and improve patient comfort.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old, ≤ 75 years old;
* Gastrointestinal tract raised lesions can be seen in gastrointestinal microscopy;
* Ultrasonic endoscopy of small probes under intravenous anesthesia is proposed;
* Clearly understand and voluntarily participate in the study, and sign an informed consent form.

Exclusion Criteria:

* Exclude patients who do not meet the requirements of conventional small probe ultrasound endoscopy and sedation due to their own conditions: for example, arrhythmias, heart failure, acute myocardial infarction, bronchial asthma during attacks, cervical and thoracic spinal deformities, delirium, mental disorders, duodenal perforations with acute inflammation, etc.;
* Exclude patients with long-term use of opioids and benzodiazepines;
* Elimination of pregnant and breastfeeding patients.
Camrelizumab Combined with Rivoceranib and Hepatic Arterial Infusion Chemotherapy (HAIC) As Conversion Therapy for Potentially Resectable Hepatocellular Carcinoma(HCC)

The purpose of this phase 2/3 study is to investigate the efficacy and safety of camrelizumab combined with rivoceranib and hepatic arterial infusion chemotherapy (HAIC) as conversion therapy for Potentially Resectable HCC.

This is a multicenter, open-label, randomized study designed to evaluate the efficacy and safety of camrelizumab combined with rivoceranib and HAIC as conversion therapy.

Eligible patients will be randomized into camrelizumab + rivoceranib + HAIC group and camrelizumab + rivoceranib group. Patients in camrelizumab + rivoceranib + HAIC group will receive systemic therapy and no more than 6 cycles HAIC procedure. Tumor response assessment using CT and/or MRI will be conducted according to RECIST v1.1. Those who are assessed as CR/PR or SD and considered suitable for curative hepatic resection will receive surgry. Surgical approaches will be tailored to the individual patient according to local standards with the goal of achieving R0 resection.The first administration of postoperative camrelizumab + rivoceranib treatment is recommended to start within 4-6 weeks after surgery, requiring full recovery from the surgery prior to post-operative camrelizumab + rivoceranib treatment. Patients in camrelizumab + rivoceranib group will receive the systemic therapy until progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form (ICF)
2. Aged ≥18 years and ≤75 years at time of signing ICF
3. Documented diagnosis of HCC confirmed by histology/cytology or clinically
4. Patients with BCLC stage B (the sum of number of tumors and the maximum diameter of the largest tumor exceeding Up-to-7 criteria) and BCLC stage C without extrahepatic metastasis: ① tumors confined to one lobe (left, right, or middle lobe), or tumors in one lobe are present alongside a single tumor with diameter ≤5 cm or up to three tumors each with diameter ≤3 cm in the remaining lobes; ②No PVTT involving the contralateral liver lobe or reaching the superior mesenteric vein. And no tumor thrombus of the inferior vena cava reaching right atrium
5. At least one measurable lesion (per RECIST v1.1) untreated lesion
6. ECOG performance status of 0 or 1
7. Child-Pugh ≤7 score
8. Life expectancy ≥12 weeks
9. Adequate organ function
10. No prior anti-tumor systemic therapies for HCC

Exclusion Criteria:

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
2. Other active malignant tumor except HCC within 5 years or simultaneously
3. Prior locoregional therapy (such as TACE、TAE、HAIC、TARE)
4. There is an absolute contraindication to HAIC
5. History of hepatic encephalopathy
6. Diffuse HCC, intrahepatic tumor burden \> 50%
7. PVTT reaching the superior mesenteric vein, and bilateral PVTT are present
8. Clinically significant ascites
9. Prior allogeneic stem cell or solid organ transplantation
Oxygenation Via Frova Bougie and Ambu Bag

We will conduct this study to show that it is possible to deliver air through a Frova bougie and an Ambu® bag.

Participants will be invited to squeeze an Ambu® bag connected to a Frova bougie, and we will measure the volume of air delivered and peak pressure generated.

Eligibility Criteria:
Inclusion Criteria:

* staff, fellows and resident anesthesiologists

Exclusion Criteria:

* injury to hand
Effects of Functional Postural Control Training on Functional Performance in People With Parkinson's Disease With Freezing of Gait

The purpose of this single-blinded, randomized controlled study aims to establish the effects of functional postural control training on functional performance and FOG in PD individuals with FoG as compared with treadmill training.

Background and purpose: Freezing of gait (FoG), is a common sign in patients with Parkinson's disease (PD), especially at the advanced stage. Advanced functional activities, such as dual task walking, turning, or crossing a door often induce the FOG. FoG is a complex phenomenon which pathophysiology is currently unknown. However, previous studies have found that postural instability may be a risk factor for FoG. In addition, previous studies have suggested the interactions between FoG and postural instability. Treadmill training has been shown to be relatively more effective to improve FoG than other interventions. On the other hand, postural control training was demonstrated to improve the severity of FoG and postural control in freezers. However, no study has investigated the effectiveness of functional postural control training on functional performance and FOG. Therefore, this study aims to establish the effects of functional postural control training on functional performance and FOG in PD individuals with FoG as compared with treadmill training.

Methods: This study is a single-blinded randomized controlled trial. Twenty PD people with FoG will be recruited and randomized to the experimental and control group. The experimental group will receive functional postural control training, and the control group will receive treadmill training. Each intervention is 30 minutes/ session, 3 sessions/ weeks, for 4 weeks. The primary outcome is functional performance, which will measure the walking speed, cadence, and step length in the four conditions, including (1) Time up and go test, (2) Dual task Time up and go test, (3) 360º turning in place, and (4) Walking through the door. The secondary outcome is the severity of FoG which is assessed by the New Freezing of Gait Questionnaire (NFOGQ). All outcomes will be assessed before and after the training program. Demographic data at baseline will be analyzed by using Chi-square test or independent T-test. Two-way repeated ANOVA will be performed to analyze the primary and secondary outcomes. The significance level is set at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Hoehn and Yahr stage 2\~4
* Age between 50 to 80 years
* New Freezing of Gait Questionnaire score \> 1
* Able to walk independently for at least 10 meters
* MMSE score ≥24

Exclusion Criteria:

* Neurological diseases other than PD
* Any cardiovascular, pulmonary, or orthopedic conditions that would impact participation in the study
Effects of Community-based Caring Contact on Post-discharge Young Adults With Self-harm

The study will determine whether community-based caring contact via a mobile app connection with or without volunteer support in addition to treatment as usual (psychiatric and psychosocial treatments) has an effect on suicidal ideation and treatment compliance among post-discharge self-harm young adults.

The proposed study will determine whether community-based caring contact via a mobile app connection with or without volunteer support in addition to treatment as usual (TAU; psychiatric and psychosocial treatments) is effective in reducing suicidal ideation, enhancing treatment compliance, reducing thwarted belongingness and perceived burdensomeness and hopelessness among post-discharge self-harm young adults, and if personalized contact by volunteers has additional effects reducing suicidal ideation among post-discharge self-harm individuals.

108 participants aged 18-45 with an index self-harm episode will be recruited from the Accident \& Emergency Department (AED) of 4 local public hospitals, and randomized into the TAU, mobile app group with, and without volunteer support. Each participant will complete a questionnaire at the 4 measurement time points at baseline (T0), one-month (T1) and the end of the 2-month intervention period (T2), and post-intervention at the three-month point (T3) from the baseline. The primary outcomes include Suicidal ideation, hopelessness, thwarted belongingness \& perceived burdensomeness, treatment (TAU) compliance, and suicidality.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with an index episode of self-poisoning or self-injury with or without suicide intent, based on the ICD-10 codes for self-harm with and without suicide intent (i.e., X60 to X84 and R45.8)
* Admission to the AEDs at the 4 collaborating public hospitals in Hong Kong (United Christian Hospital, North District Hospital, Queen Mary Hospital, and Pamela Youde Nethersole Eastern Hospital)
* Mentally well assessed by a psychiatrist or Consultation Liaison Nurses (CLNs)
* Capable of providing written Informed Consent Form

Exclusion Criteria:

* Individuals with DSM-IV-TR Axis II disorder; or
* Individuals with severe psychotic mental illness or bipolar disorder
Pyronaridine-artesunate With Low Dose Primaquine for Preventing P. Falciparum Transmission

The purpose of this study is to assess the gametocytocidal and transmission reducing activity of pyronaridine-artesunate (PA) and dihydroartemisinin-piperaquine (DP) with and without a single low dose of primaquine (PQ; 0.25mg/kg). Outcome measures will include infectivity at 2 and 7 days after treatment, the duration of infectivity in the artemisinin combination therapy (ACT) only arms, and the production and detectability of histidine rich protein II.

Protocol will be shared on request

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 5 years and ≤ 50 years
* Absence of symptomatic falciparum malaria, defined by fever on enrolment
* Presence of ≥16 gametocytes/µL (i.e. ≥1 gametocytes recorded in the thick film against 500 white blood cells)
* No allergies to study drugs
* Use of antimalarial drugs over the past 7 days (as reported by the participant)
* Hemoglobin ≥ 9.5 g/dL
* Individuals weighing \>\< 80 kg
* No evidence of severe or chronic disease
* Written, informed consent

Exclusion Criteria:

* Age \< 5 years or \> 50 years
* Pregnancy
* Previous reaction to study drugs/known allergy to study drugs
* Signs of severe malaria
* Taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine)
* Blood transfusion within the last 90 days
* Patients with clinical signs or symptoms of hepatic injury (such as nausea and/or abdominal pain associated with jaundice) or known severe liver disease (i.e. decompensated cirrhosis, Child-Pugh stage B or C).
* Patients with clinical signs or symptoms of renal impairment or known renal impairment
* Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
* Taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes - macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride.
* Consent not given
Effects of Diaphragm Manual Therapy Verses Sustained Natural Apophyseal Glide in Mechanical Neck Pain

Mechanical neck pain is defined as pain and discomfort localized between the superior nuchal line, cervical spine, and the spinous process of the first thoracic vertebra. Some of the most typical factors include continuous use of mobile phones and computers, working in sedentary jobs, etc. Study aimed to compare diaphragm manual therapy and Sustained Natural Apophyseal Glide on pain, range of motion and functional disability in patients with mechanical neck pain.

This project will be a Randomized Clinical Trial conducted to check the effects of Diaphragm manual therapy versus sustained natural apophyseal glide on pain, range of motion and functional disability in patients with mechanical neck pain at Sehat Medical Complex Lahore through non-probability convenient sampling technique on 34 patients will be allocated using simple random sampling through Computer generated Randomization into Group A and Group B. Group A will be treated with Diaphragm Manual Therapy and baseline treatment was given and Group B with Sustained Natural Apophyseal Glide and baseline treatment was given. All Exercise were performed 3 times a week for total 4 weeks. Outcome measures will be conducted through NPRS for pain, ROM measured by Goniometer, and Neck Disability Index (NDI) for Disability after 4 weeks. Data was analyzed during SPSS software version 25. After assessing the normality of data by the Shapiro-Wilk test, it decided whether either parametric or non-parametric tests were used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age group between 18 and 40 years
* Both gender male and female
* Individuals having localized pain or stiffness in the cervical spine or both combined between C3 and C7 without upper-limb radiculopathy
* Pain reported on NPRS score ˃3 to \<7/10 in neck region for more than 3 months.
* Limited Neck ROM
* Negative Spurling's test, traction test, upper limb tension test, and shoulder abduction test

Exclusion Criteria:

Patients were excluded if they were diagnosed with the following conditions for ˃6 months

* Tuberculosis, carcinoma, heart disease, and osteoporosis
* Neural disorders due to prolapsed intervertebral disc
* Any trauma or localized infection in neck region
* Upper motor neuron disease, cervical stenosis, and metabolic diseases in bone and joint
* Hyper flexibility
* Open sores
* Ongoing radiotherapy, chemotherapy, steroid therapy, or anticoagulants
* Psychiatric diseases such as phobia/obsession and depression
* Allergy to hot pack
* Patients with history of surgery in cervical spine region with in a year.