cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Adverse Events and How Oral ABBV-552 Capsules Moves Through the Body of Healthy Adult Japanese and Han Chinese Participants

This study will assess how safe ABBV-552 is and how ABBV-552 moves through the body of adult healthy Japanese and Han Chinese participants. Adverse Events will be assessed.

ABBV-552 is an investigational drug being developed for potential treatment of Alzheimer's disease (AD). Approximately 18 adult healthy Japanese and Han Chinese volunteers will be enrolled in 2 sites in the United States.

Japanese participants assigned to Arm 1 will receive ascending doses of ABBV-552 oral capsules once every week for 3 weeks. Han Chinese participants assigned to Arm 2 will receive oral ABBV-552 capsules on Day 1. All participants will be followed for 30 days after their last dose.

Participants will be confined for 22 days or 8 days depending on the Arm they are assigned to. Adverse Events and blood tests will be performed.


Eligibility Criteria:
Inclusion Criteria:

- Japanese participants must be first- or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.

OR

* Han Chinese participants must be first-generation Han Chinese of full Chinese parentage residing outside of China for less than 5 years. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.

Exclusion Criteria:

- Has no other clinically significant and/or unstable medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive ABBV-552.
The Effect of Intraoperative Tramadol on Postoperative Opioid

Postoperative pain remains a very UNPLEASENTevent, particularly in morbidly obese patients that may be associated with obstructive sleep apnea. Bariatric surgery patients must get safe and efficient analgesia, which is essential given that up to 45 % of patients report substantial pain in the first two days following surgery. The study's purpose was to compare the efficacy and safety of combined tramadol with pethidine versus pethidine alone and to assess their impact on postoperative pethidine requirements after LSG for morbidly obese patients

This multicenter cohort research included patients with morbid obesity who had LSG between January 2021 and December 2022. The patients included in the study were allocated to one of two treatment groups that were not randomized but the patients were categorized according to the time of surgery: Group A received Pethidine alone in the period between January 2021 and December 2021, while Group B got Tramadol with pethidine in the period between January 2022 and December 2022. Doses were based on the patient's actual body weight.

Eligibility Criteria:
Inclusion Criteria:

* Patients with morbid obesity defined as a BMI of more than 40 or
* BMI less than 35 with at least one comorbidity and
* ages ranging from 16 to 65, were patients

Exclusion Criteria:

* Patients under the age of 16 or over 65,
* Those with severe GERD, leakage
* pregnancy, or
* inflammatory bowel disease,
Hypercoagulability Study Using Haemostatic Techniques in Patients With Inflammatory Bowel Disease

Descriptive study, in which the haemostatic profile of ambulatory patients with IBD will be analyzed by means of ROTEM and other techniques, such as the thrombin generation test and the study of platelet function by flow cytometry.

Descriptive study, in which the haemostatic profile of ambulatory patients with IBD will be analyzed by rotational thromboelastometry (ROTEM) and other techniques, such as thrombin generation test and platelet function study by flow cytometry. The results of these measurements will be subsequently compared between the different IBD patient groups, stratified by activity and other risk factors, as well as with healthy controls, in order to define in which of these situations a significant prothrombotic risk exists, and which part of the coagulation cascade conditions that risk. After this, we will describe the incidence and prevalence of thromboembolic events in the follow-up of these patient groups. Finally, an attempt will be made to determine, according to the results of the study if any of the situations outside the classic recommendations would be subsidiary to receive chemoprophylaxis for the thromboembolic events.

The aim of this study is to determine the possible state of hypercoagulability of ambulatory patients with Inflammatory Bowel Disease, stratified according to the characteristics of their disease, by using ROTEM as well as the thrombin generation test. Platelet function will also be evaluated by flow cytometry.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patients diagnosed with UC according to ECCO criteria, in ambulatory follow-up in the IBD unit, stratified in remission and mild or moderate ambulatory management activity, determined by clinical (Simple Clinical Colitis Activity Index: SCCAI), biological (fecal calprotectin: CF), and/or endoscopic (Mayo Index) criteria: Remission: defined as a SCCAI \< 2 and/or CF \< 150 and/or May 0 index Activity: defined as an SCCAI \>2, and/or CF \> 150, and/or May Index \>= 1 and \<3.
* Patients diagnosed with CD according to ECCO criteria, in ambulatory follow-up in the IBD unit, stratified according to remission and mild or moderate ambulatory management activity, determined by clinical criteria (Harvey-Bradshaw index: HBI), biological criteria (CF) and/or endoscopic criteria (Simple Endoscopic Score-CD: SES-CD):

Remission: HBI \< 5, and/or CF \< 150, and/or SES CD \< 3. Activity: HBI \>=6 and \<16, and/or CF \> 150, and/or SES-CD \>=3 (\>4 if isolated ileal affectation) and \<=15.

Exclusion Criteria:

* Patients with a previous history of venous or arterial thromboembolism
* Patients with recent hospitalization or surgery in the last 3 months.
* Women who are pregnant, undergoing treatment with oral contraceptives or who have received oral contraceptives in the last 3 months.
* Patients undergoing anticoagulation and/or active antiaggregation treatment
* Patients with severe activity criteria
* Patients with other concomitant conditions that favor thrombosis events
Effects of Effleurage Abdominal Massage on Pain and Quality of Life in Primary Dysmenorrhea Among Students in Lahore

To find out the answer of the study question that effleurage abdominal massage has any effect on pain and quality of life in primary dysmenorrhea among university students or nota study will be conducted with an objective to evaluate the effects of effleurage abdominal massage on pain and quality of life in primary dysmenorrhea among university students

Primary dysmenorrhea, the commonly occurring gynecological issue faced by young girls. It severely affects quality of female life. It leads to fatigue, psychological issues, lack of interest in selfcare and daily activities that results in absenteeism at work and educational institutes. It also badly affects academic performance and extra-curricular activities. Different pharmacological and non-pharmacological interventions are being used for reducing its negative effects, such as effleurage abdominal massage intend to decrease the problems faced by students as a result of this frightening issue. Here the question arises for health professionals that effleurage abdominal massage has any effect on pain and quality of life in primary dysmenorrhea among university students or not? To find out the answer of this question a study will be conducted with an objective to evaluate the effects of effleurage abdominal massage on pain and quality of life in primary dysmenorrhea among university students. This study holds considerable implications in addressing potential adverse effects associated with pharmacological analgesic agents, thereby mitigating pain, lack of interest in work and enhancing functional capacity, hence improving quality of life. Moreover, it is anticipated to contribute to the reduction of healthcare costs.

Eligibility Criteria:
Inclusion Criteria:

* Unmarried female university students from Lahore
* Aged between 18-25 years
* Diagnosed patients by gynecologist with primary dysmenorrhea for three previous consecutive cycles.
* Regular menstrual cycles ranging 21-35 days lasting for 3-7 days.
* Having pain score of 6 or more than 6 on Numeric Pain Rating Scale

Exclusion Criteria:

* Presence of any known abdominal or pelvic disease.
* Obstructive vaginal or uterine congenital anomalies.
* Presence of known or suspected secondary dysmenorrhea.
* History of major abdominal or pelvic surgery in the previous three months.
* History of hormonal therapy in the last six months.
* History of using analgesics during menstruation.
* History of having any medical disease i.e. cardiac and renal disease.
* Participants doing regular exercise.
Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression

The objectives of this study are to evaluate the safety and efficacy of applying electrical stimulation on the promontorium (EPS) for the suppression of tinnitus in a sub-chronic stimulation regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Total score on the Handicap Inventory (THI) of at least 40.
2. Visual scale over 5.
3. Tinnitus origin is peripheral (related to long term noise exposure, or to a sudden exposure to a very loud noise etc.)
4. Tinnitus is on-going; present for more than 50% of the time over the past 12 months.
5. Unilateral tinnitus
6. Tinnitus prevalent at least 12 months.
7. Willingness to abstain from part taking in other, non-study procedures indicated to lessen tinnitus and/or its perception.
8. Willing and able to refrain from engaging in activities or work involving loud noise exposure.
9. Male or females 18-60 years of age

Exclusion Criteria:

1. Prior history of sudden hearing loss and/or fluctuating hearing levels.
2. Tinnitus prevalent more than 3 years.
3. History of frequent middle ear infections
4. Patient under immunosuppressant therapy
5. Auditory nerve damage.
6. Vestibular Schwannoma
7. Cochlear implant.
8. Pregnant or lactating.
9. Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements.
10. Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss.
11. Not being physically or geographically capable of returning for scheduled follow-up visits.
12. Any physical, psychological, or emotional disorder that would interfere with the planned surgical operations
13. Mentally retarded, developmentally delayed or suffering from organic brain dysfunction.
Surgery for Pancreatic Cancer With Oligo-Metastasis

Pancreatic cancer is increasing in incidence and will be the second leading cause of cancer-related deaths in 2030 in the West. Only 10 to 15% of patients are eligible for curative resection with long-term survival rarely exceeding 20% at 5 years. The management of metastatic or recurrent diseases can not, unfortunately, be recommended to date because of limited data available (INCA 2019).

However, recent, low-strength publications have reported encouraging results on the long-term survival of stage IV or recurrent patients.

The aim of the present retrospective cohort study is to analyze results of surgery/destruction of metastatic synchronous or metachronous disease or local recurrence in patients with stage IV pancreatic cancer


Eligibility Criteria:
Inclusion criteria:

- Patients who had resection or destruction of one or more synchronous or metachronous metastases or local recurrence of pancreatic adenocarcinoma

Details:

* synchronous lesions, metachrones can be included
* all distant lesions (hepatic, pulmonary) can be included
* documented lymph node involvement after analysis of the specimen (hepatic hilum, mesenteric root, retroperitoneal or inter-aortic-cellar) can be included
* patients with local recurrence who underwent surgical treatment

Exclusion Criteria:

- Patient who reject the study protocol
Cystic Fibrosis and Fit-to-Fly

Due to the hypobaric hypoxia during air travel, some patients with Cystic Fibrosis (CF) need supplemental oxygen during air travel.

The study aims to evaluate if adding exercise desaturation to the pre-flight evaluation will help predict requirements for in-flight supplemental oxygen.

According to the British Thoracic Society (BTS) recommendations regarding pre-flight evaluation in patients with pulmonary disease, pre-flight arterial oxygen saturation or lung function tests do not discriminate sufficiently between those who need supplemental oxygen during flights, and those who can do without.Therefore, more extensively use of Hypoxia Altitude Simulation test (HAST) has been advocated. However, this test is not widely available. Previous studies have shown that exercise testing is useful for the prediction of in-flight hypoxemia. The investigators have previously developed a pre-flight algorithm for patients with chronic obstructive pulmonary disease (COPD), based on oxygen saturation measured by pulse oximetry at rest and during exercise (six minute walking test (6MWT)). It remains unknown as to whether these results are applicable to the CF population.

The current study aims to validate the pre-flight algorithm for patients with CF. Since a maximum cardiopulmonary exercise test (CPET) is recommended in the routine CF-control, the investigators also aim to evaluate whether the use of CPET predicts in-flight hypoxemia with greater accuracy than 6MWT, and whether CPET may replace HAST.

Eligibility Criteria:
Inclusion Criteria:

* Adult CF patients (age from 18 years)
* Signed informed consent

Exclusion Criteria:

* Ongoing exacerbation
* Unable to fulfill a CPET or 6MWT
* Long-term oxygen treatment (LTOT)
* Severe heart disease
* Language problems that interfere with data collection
Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors

The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software.

The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software. Subjects fitted with one or two Ponto sound processors will be invited to participate in an online survey. The survey contains questions about the subjectively experienced performance and satisfaction of the device. The survey can be filled out on computer, tablet or mobile phone and should take the participants about 10 minutes to fill out.

Eligibility Criteria:
Inclusion Criteria:

Online consent form filled out Has been fitted with at least one Ponto Sound Processor

Exclusion Criteria:

No exclusion criteria
A Study of Pembrolizumab (MK-3475) With or Without V940 in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

The goal of this study is to learn if people who receive V940 and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving V940 and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American Joint Committee on Cancer (AJCC) 8th Edition\]
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
* Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
* Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\])
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Diagnosis of SCLC or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor
* Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
* Received prior neoadjuvant therapy for their current NSCLC diagnosis
* Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein \[CTLA-4\], OX-40, CD137)
* Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
* Received prior treatment with a cancer vaccine
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels

To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.

To compare the effects of rosuvastatin to protease inhibitor switching on:

* Total cholesterol through week 12
* Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy)
* Quality of life (SF-12)
* Fasting LDL cholesterol (estimated with Friedewald equation unless triglycerides \>400mg/dL, in which case LDL-C would be measured directly), HDL cholesterol, total : HDL cholesterol ratio, LDL particles sizes, triglycerides
* Fasting glucose and insulin
* Framingham cardiovascular risk score
* D:A:D 5-year estimated risk calculator

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive status
* Adults (≥18 years of age)
* Stable and well-tolerated combination ART including a ritonavir-boosted protease inhibitor for the previous 6 months
* HIV RNA \<50 copies/mL for at least the preceding 3 months
* Fasting total cholesterol ≥5.5 mmol/L (\>213 mg/dL)
* Framingham risk score ≥8% at 10 years OR diabetes mellitus OR a family history of premature coronary artery disease in a first-degree relative
* Provision of written, informed consent

Exclusion criteria:

* Any statin in the previous 12 weeks
* Previous statin-induced myopathy or hepatitis
* History of coronary artery disease, stroke or any other indication for the use of statin therapy (hyperlipidaemia: genetic, secondary or idiopathic)
* Concurrent use of:

  1. oral corticosteroids use other than for replacement therapy (i.e. prednisolone 5-7.5 mg, hydrocortisone 20-30 mg, cortisone acetate 25-37.5 mg daily)
  2. other immunosuppressive or immunomodulating drugs
* Contraindication to rosuvastatin therapy:

  1. liver transaminases \>5 times the upper normal limit
  2. creatinine clearance \<30 mL/min
  3. known myopathy
  4. current fibrate therapy
  5. known resistance to one or more "backbone" ART drugs
* No potent switch ART drug available to replace the current ritonavir-boosted protease inhibitor
* Known intolerance to rosuvastatin or the proposed switch ART drug
* Women attempting or likely to become pregnant, or who are pregnant or breast-feeding
* A patient with a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study
* Unable to complete study procedures
Comparison of COVID-19 and H1N1 Influenza Pneumonia

To explore the different clinical and CT features distinguishing COVID-19 from H1N1 influenza pneumonia.

COVID-19 pneumonia patients showed less proportions of underlying diseases, fever and respiratory symptoms than those of H1N1 pneumonia patients (p\<0.01). White blood cell count, neutrophilic granulocyte percentage, C-reactive protein, procalcitonin, D-Dimer and lactate dehydrogenase in H1N1 pneumonia patients were higher than those of COVID-19 pneumonia patients (p\<0.05). H1N1 pneumonia were often symmetrically located in the dorsal part of lung inferior lobes, while COVID-19 pneumonia were unsually showed a peripheral but non-specific lobe distributions. Ground glass opacity was more common in COVID-19 pneumonia and consolidation lesions was more common in H1N1 pneumonia (p\<0.01). COVID-19 pneumonia lesions showed a relative clear margin compared with H1N1 pneumonia. Crazy-paving pattern, thickening vessels, reversed halo sign and early fibrotic leisions were more common in COVID-19 pneumonia than H1N1 pneumonia (p\<0.05). Pleural effusion in COVID-19 pneumonia was significantly less common than H1N1 pneumonia (p\<0.01).

Compared with H1N1 pneumonia in Zhejiang, China, the clinical manifestations of COVID-19 pneumonia was more concealed with less underlying diseases and slighter respiratory symptoms. The more common CT manifestations of COVID-19 pneumonia included ground glass opacity with a relative clear margin, crazy-paving pattern, thickening vessels, reversed halo sign and early fibrotic leisions, while the less common CT manifestations of COVID-19 pneumonia included consolidation and pleural effusion.

Eligibility Criteria:
Inclusion Criteria:

* pneumonia

Exclusion Criteria:

* no pneumonia