cyrilzakka/clinical-trials huggingface dataset:
Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy

In this study, the investigators hypothesize that preemptive scalp block in neurosurgical patients may decrease incidence of PONV after craniotomy through decreasing intraoperative inhalational agents' concentration and decreasing intraoperative opioids requirements, with better intraoperative hemodynamics and lesser recovery time

Patients will be recruited after admission to the hospital for surgery. Randomization will be performed using computer-generated random number tables in opaque sealed envelopes prepared by an anesthesiologist who will be not part of the study

Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C received scalp block using 20 mL normal saline and will be considered as control group.

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II patients,
* aged 18 to 50 years,
* 70-80 kg,
* undergoing elective supratentorial craniotomy

Exclusion Criteria:

* patients under 18 years of age,
* pregnancy,
* emergency surgery,
* patients with a Glasgow Coma Score (GCS) less than 15,
* those with documented allergy to bupivacaine,
* regular communication not possible,
* Patients requiring prolonged mechanical ventilation (\> 2 hours after end of surgery) will be also excluded
Intervention Study on Hypertension Management Combined With Health Promotion at Commune Level

A quasi-experimental study design was chosen to compare the model of hypertension management at commune-level with conventional management for people with high blood pressure in two communes (one for intervention versus one for reference).

A intervention model included the commune-based programme on hypertension management combined with comprehensive health promotion campaigns

A quasi-experimental study design was chosen: two communes were purposively selected from Ba-Vi setting: Phu-Phuong for reference and Phu-Cuong for intervention communes A hypertension management programme and the nested comprehensive health promotion campaigns were implemented simultaneously in Phu-Cuong while nothing performed in Phu-Phuong except for local conventional healthcare services.

The health promotion campaigns aimed at smoking cessation, reduction of alcohol consumption, encourage of unsalted diet and physical activity, all of which targeted to every local inhabitants.

The hypertension management programme focused on monthly check-ups, drug delivery and individual lifestyle consultation, all of which targeted to hypertensives only.

Baseline cross-sectional survey was used to assess cardiovascular pattern in local community before intervention and recruit people with high blood pressure for the management programme in intervention commune Repeated cross-sectional surveys were used to evaluate the impacts of health promotion.

Cohort study on hypertensives was used to evaluate the impacts of the management programme.

Eligibility Criteria:
Inclusion Criteria:

* Adult people above 25

Exclusion Criteria:

* People deny to join the study
Safety and Performance of ENTACT Septal Staple System for Septoplasty

This is a prospective, multi-center, single arm PMCF study to evaluate the safety and performance of the ENTACT (Next Generation) resorbable staple system for septoplasty in 40 subjects. The study purpose is to provide evidence to satisfy the PMCF requirements of CE Marking to market this device in Europe (data may be used to support registrations on other countries as well).

The primary objective of this study is to demonstrate clinical success of the ENTACT (Next Generation) resorbable septal staple system by examining the patient's nasal cavity at the 21 day follow-up visit.

The secondary objectives are to generate performance and health economics data to support the use of ENTACT (Next Generation) resorbable septal staple.

Eligibility Criteria:
Inclusion Criteria:

The patient will be eligible for the study if he or she meets all of the following inclusion criteria at the baseline screening:

1. Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board (IRB);
2. Clinically significant deviation of the nasal septum;
3. Willing and able to make all required study visits;
4. Able to read and understand the approved informed consent form and patient reported outcome assessments (written and oral)

Exclusion Criteria:

The patient will be ineligible for the study if he or she meets any of the following exclusion criteria at the baseline screening or during surgery:

1. Prolonged tissue approximation beyond that needed for normal tissue closure is necessary or desired;
2. Traditional suturing techniques are necessary;
3. Radiopacity is necessary or desired since ENTACT septal staples are radiotransparent;
4. Known to be allergic to foreign body of materials of investigational product;
5. Concomitant procedures other than turbinectomy, turbinate reduction, and/or sinus surgery;
6. Pregnancy at time of procedure;
7. Presence of infection at the site;
8. Severe drug and alcohol abusers;
9. Autoimmune disease deemed clinically significant by Principal Investigator (PI).
Early Mobilization in the ICU

To study all ICU patients with an independent baseline functional status , who experience a critical illness requiring intubation and mechanical ventilation evaluating long-term cognitive and executive function and long term cost effectiveness in survivors who required mechanical ventilation.

Immediate mobilization of mechanically ventilated (MV) ICU patients is not part of usual care in the U.S. or internationally. Our previous work supports that early mobilization through physical and occupational therapy for ICU patients on the ventilator can help them experience less delirium, spend less time in the ICU and hospital, and become more independent when they leave. To advance our knowledge in this area, large longitudinal studies are needed to understand the long-term physical, cognitive and mental health status of survivors and to test how specific ICU therapies may affect these outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Intubated and MV \> 24, \< 96 hours
* Baseline Barthel Index Functional Score \> 70, functional at home

Exclusion Criteria:

* Rapidly changing neurological conditions (e.g. stroke)
* Cardiac arrest as cause for respiratory failure
* Elevated intracranial pressure
* Pregnancy (due to inability to provide continuous fetal monitoring)
* Terminal condition (life expectancy \< 6 months)
* Traumatic brain injury, multiple limb fractures, pelvic fractures,
* Severe chronic pain syndrome on admission
Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients

The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.

Allocation: Randomized nonstratified

Intervention model: Parallel versus comparator

Eligibility Criteria:
Key Inclusion Criteria

* Current treatment regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus any third agent for at least 3 months immediately prior to screening
* Virologic suppression (HIV-1 RNA \<50 c/mL) for at least 3 months immediately prior to screening
* Virologic suppression (HIV-1 RNA \<40 c/mL) using the Abbott m2000rt® polymerase chain reaction assay during screening period
* Treatment-related safety and/or tolerability issues to a regimen consisting of 2 NRTIs plus any third agent

Key Exclusion Criteria

* History of switch in highly active antiretroviral therapy due to virologic failure
* History of genotypic resistance to any component of the study regimen (atazanavir, raltegravir, tenofovir/emtricitabine)
* History of exposure to atazanavir/ritonavir or raltegravir prior to entering the study
* Experiencing safety and/or tolerability issues to tenofovir/emtricitabine or raltegravir
* Switch of any component of HIV antiretroviral medication regimen in the last 3 months immediately prior to or during the screening period
Effects of Treadmill Gait Training With Loading in Individuals With Stroke

The purpose of this study is to determine whether the add load on non-paretic lower limb of individuals that suffer a stroke, while walking on a treadmill, is effective for restore gait symmetry of these individuals, in a subacute phase of stroke.

This is a randomized and blinded clinical trial, in which participants are being randomly divided into experimental group and control group, in order to verify the effects of adding load on gait symmetry after stroke. 40 individuals will participate, and the calculation of sample size was performed from the ratio variable symmetry of swing time, based on previous study. Whereas about 15% of individuals could give up to participate in the study during their course (dropout rate), we determined a number of 20 participants in each group.

Eligibility Criteria:
Inclusion Criteria:

* First episode of stroke (ischemic or hemorrhagic) which determined unilateral hemiparesis
* Time of lesion less one year
* Able to walk independently by 10 feet on flat surface without the use of assistive devices
* Gait speed less than 0.8 m / s
* Ability to understand and obey simple commands

Exclusion Criteria:

* Instability of cardiac conditions
* Adverse clinical conditions affecting balance and / or gait
* Pain and / or severe discomfort that impede the realization of the proposed activities
* Decompensation in systemic blood pressure, with the systolic and diastolic values above 200 mmHg and 110 mmHg, respectively, before and / or after training
* Submaximal heart rate above the allowed values during training
Renal Transplant Injury and the Renin-Angiotensin System in Kids (RETASK)

In pediatric kidney transplant patients, rejection, medication toxicity and ischemia cause early and chronic renal allograft injury, which reduces graft lifespan and patient survival. Early detection of injury would facilitate prevention and treatment. The gold standard surveillance biopsy has limitations including delayed discovery of injury. No noninvasive test identifies graft injury before it is clinically apparent. This project's goal is to develop a novel early marker of subclinical graft injury to facilitate prompt recognition and treatment.

Kidney damage activates the traditional renin-angiotensin (Ang) system (RAS), characterized by Ang-converting enzyme (ACE)/Ang II/Ang II type 1 receptor. The Ang-converting enzyme 2 (ACE2)/Ang-(1-7)/Mas pathway counteracts this damage. The balance, or ratio, between levels of the ACE/Ang II and ACE2/Ang-(1-7) pathways may be clinically important because Ang-(1-7) counteracts Ang II-mediated injury. An increase in ACE and Ang II expression and a decrease in ACE2 and Ang-(1-7) expression on tubular cells may promote renal injury. Tubular damage may increase urinary loss of protective ACE2 and Ang-(1-7), propagating renal damage by allowing ACE and Ang II to stimulate inflammation and fibrosis unopposed. The investigators hypothesis is that a shift in the urinary ACE-to-ACE2 and Ang II-to-Ang-(1-7) ratios towards ACE2 and Ang-(1-7) predicts acute graft injury diagnosed on renal biopsy and predicts chronic graft damage on renal biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Ages 1 - 20 years
* Actively listed on the transplant list at Lucile Packard Children's Hospital at Stanford and received a renal transplant during the study enrollment period

Exclusion Criteria:

* Transplanted at a center other than Lucile Packard Children's Hospital at Stanford
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of a 200-mcg Dose

To determine the safety of and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) at a dose of 200 mcg in human volunteers; to evaluate duration of antibody response and its relationship to the dose and frequency of inoculation.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that the ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that the ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Healthy, adult volunteers without identifiable high-risk behavior for HIV-1 infection are randomly assigned to receive three injections of either 200 mcg gp160 vaccine or a placebo. At each participating site, four volunteers receive vaccine and two volunteers receive placebo. Primary immunization and two booster immunizations at day 30 and day 180 are done in an outpatient setting. Volunteers are closely monitored for the first 2 weeks postimmunization (primary and boosters), and extensively followed for 2 years. Volunteers may be offered an additional booster of the same preparation at 12 months.

Eligibility Criteria:
Inclusion Criteria

Patients must be:

* Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
* Available for 2 years of follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* History of positive PPD (tuberculin test) and abnormal chest x-ray.
* Positive syphilis serology (e.g., RPR).
* Positive for circulating hepatitis B surface antigen.

Patients with the following are excluded:

* They or their sexual partners have identifiable high-risk behavior for HIV infection.
* History of immunodeficiency or chronic illness.
* Evidence of psychological or psychiatric problems that may lead to noncompliance.

Prior Medication:

Excluded:

* Immunosuppressive medications.

Prior Treatment:

Excluded:

* Blood transfusions or cryoprecipitates within the past 6 months.
Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients

A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.


Eligibility Criteria:
Inclusion Criteria:

* Recipient of a first-time kidney transplant
* Between the ages of 18 and 70 years, inclusive

Exclusion Criteria:

* Recipient of any non-kidney transplant
Preemptive Oral Gabapentin 600 mg in Reducing Morphine Requirement After Non Obstetric Lower Abdominal Surgery

This study aimed to get the information about the effectiveness of preemptive oral gabapentin 600 mg in reducing morphine requirement after non obstetric lower abdominal surgery

Seventy-two subjects were given informed consent before enrolling the study and randomized into two groups; gabapentin and placebo. Two hours before the incision, patients were given preemptive analgesia, either gabapentin or placebo. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse oxymetry were set on the subjects in the operating room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with atracurium 0.5 mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. After surgery, patients were extubated until fully conscious. Patients will be transported to recovery room postoperatively. Besides paracetamol as the postoperative analgesia, we also attached patient controlled analgesia (PCA) system to patients' intravenous line using continuous ambulatory delivery device (CADD) contained morphine 1 mg/ml with settings 1 mg per requirement, interval limit within 5 minutes, maximum dose 6 mg/hour intravenously. Cumulative morphine requirement, mean visual analogue scale, and time interval after surgery to the first administration of morphine will be assessed in this study.

Eligibility Criteria:
Inclusion criteria:

* Male or female
* Age: 18-65 years old
* Weigh in range around 20% of the ideal body weight
* Physical status ASA I-II
* Scheduled for elective non-obstetric lower abdominal surgery with general anesthesia
* Duration of surgery less than 4 hours
* Patients who agreed to participate in this study and sign informed consent

Exclusion criteria:

* Patients who have history of allergy or hypersensitivity to gabapentin, paracetamol, morphine, or the other opioids
* Patients who consumed analgesia and NSAID less than 12 hours before surgery
* Patients who experienced physical trauma less than 4 days before surgery
* Patients who have contraindications to gabapentin, morphine, and paracetamol
* Patients who were treated with neuraxial block or peripheral nerve block before and during surgery
* Patients who have history of diabetes, severe live or renal disease
* Patients who were treated with antihypertension, sedatives, hypnotics, antidepressants, and the other drugs that have effects on nervous system
* Patients who have psychiatric disorders
* Patients who consumed gabapentin before perioperative period
* Pregnant or breastfeeding patients
Phase II Study Evaluating the Efficacy and Safety of KX-826

This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 in Chinese adult male patients with AGA.

Based on the results of the Phase I studies of KX-826 in Androgenetic Alopecia and the pre-clinical PD studies, the investigational product will be administered at 2.5 mg BID (0.25%), 5 mg QD (0.5%), and 5 mg BID (0.5%) in treatment groups A, B, and C, respectively, with 30 patients/group; a total of 30 patients will be administered in the placebo QD group (10) and placebo BID group (20). The investigational product will be administered in the evening once daily for all QD dose groups, and once in the morning and once in the evening for the BID dose groups.

Eligibility Criteria:
Inclusion Criteria:

1. Agreeing to follow the study treatment regimen and visit plan, voluntarily enroll the study, and sign the informed consent form (ICF) in writing;
2. Male, aged ≥ 18 years, in good general health;
3. Clinical diagnosis of AGA;
4. Stage IIIv, IV and V according to Hamilton-Norwood scale.

Exclusion Criteria:

1. Patients who have used external topical drugs for alopecia sites within 3 months prior to screening;
2. Patients who have taken androgen replacement therapy； immunosuppressants, corticosteroids and other drugs that may interfere with the efficacy evaluation within 3 months prior to screening;
3. Minoxidil use within 6 months prior to screening;
4. Treatment with finasteride or dutasteride within 12 months prior to screening; Scalp radiation and/or laser or surgical therapy within 12 months prior to screening; History of malignancy;
5. Other conditions that may affect compliance or ineligibility for participation of the study.
Clinical Study of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma

The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation therapy for hepatic carcinoma.

A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 10-6-10minutes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of liver cancer based on histology or the current accepted radiological measures.
* Single Tumor size ≤5.0 cm in greatest diameter, or multiple tumor number≤3 and each tumor size≤ 3cm.
* Life expectancy: Greater than 3 months.
* Patients' liver function is Child-pugh A or B.
* Ability to understand the study protocol and a willingness to sign a written informed consent document.
* Unable to receive operative surgery.

Exclusion Criteria:

* Patients with other primary tumor except liver cancer.
* History of coagulation disorders or anemia.
Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer

This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel combined with bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.


Eligibility Criteria:
Inclusion Criteria

1. Aged 18\~75 years old
2. Histologically confirmed platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
3. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
5. Sufficient bone marrow function;
6. Sufficient liver and renal function;
7. Patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative serum or urine pregnancy test result; non-lactating women;
8. Patients had no disturbance of consciousness and volunteered to participate in the study.

Exclusion Criteria

1. Uncontrolled hypertension
2. Tumor invading vital blood vessels
3. With contraindications to chemotherapy
4. With uncontrolled infection
5. Patients had received anticancer therapy within 3 weeks before enrollment
6. Patients were allergic or intolerant to investigational drugs or its ingredients
7. Patients are not suitable for this trial as judged by investigators
Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

Molecular testing of the gut microbiome and enteric pathogens is rapidly moving beyond targeted PCR testing to next generation sequencing techniques. In addition, the current state of monitoring for soil-transmitted helminth infections is moving increasingly from microscopic techniques to molecular techniques. The targeted PCR test for soil transmitted helminth diagnosis has been validated on stool samples, but not rectal swabs. Bulk stool samples are logistically challenging and time-intensive to collect, thus participation is often far from optimal. Rectal swabs are more efficient and may result in higher participation. In this study, children will be randomized to either albendazole, azithromycin, or both drugs, after which both rectal swabs and bulk stool samples will be collected. The investigators will compare the PCR test for soil transmitted helminth infections using both the rectal swabs and the bulk stool samples. In addition, the investigators will analyze the gut microbiome of the children using next generation sequencing techniques to gain insight into effects of mass drug administration.


Eligibility Criteria:
Inclusion Criteria:

* all children 0 to 5 (up to 6th birthday)

Exclusion Criteria:

* individuals with a macrolide allergy
* refusal of parent/guardian