cyrilzakka/clinical-trials huggingface dataset:
Pregabalin and Analgesia After Laparoscopic Cholecystectomy

The purpose of this study is to evaluate how effective is the preoperative administration of pregabalin 600mg, to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy.

Acute pain frequently occurs during the postoperative period.Not treated acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of pregabalin, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that pregabalin may have a role in the post operative pain management, as an adjunct. Pregabalin is an anticonvulsant and anxiolytic drug, which have a more favorable pharmacokinetic profile from its predecessor gabapentin.

Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II

Exclusion Criteria:

* Renal or hepatic insufficiency
* Alcohol or drugs abuse
* History of chronic pain or daily intake of analgesics
* Uncontrolled medical disease (hypertension, diabetes) and cardiovascular problems. Psychiatric disorders
* Inability of patients to use PCA pump
* History of intake of non-steroidal anti-inflammatory drugs the last 24 hours before surgery,use of drainage after the surgery
TACT-NAGOYA: Therapeutic Angiogenesis Using Cell Transplantation

Clinical studies have established that implantation of bone marrow mononuclear cells (BM-MNCs) or peripheral blood mononuclear cells (PB-MNCs) into ischaemic limbs increases collateral vessel formation. We, the investigators at Nagoya University, further investigated the efficacy and safety of autologous implantation of BM-MNCs or PB-MNCs in patients with severe ischaemic limbs who have no other alternative therapeutic options. We also examined a potential limiting factor which reduced the efficacy of therapeutic angiogenesis using cell transplantation (TACT).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have chronic limb ischemia, including rest pain, non-healing ischemic ulcers, or both, and who are not candidates for nonsurgical or surgical revascularisation.

Exclusion Criteria:

* Poorly controlled diabetes mellitus (hemoglobin A1c \[HbA1c\] \> 6.5% and proliferative retinopathy)
* Evidence of malignant disorder during the past 5 years
* Subjects who cannot survive more than 1 year with other complications
* Malignant rheumatic arthritis
Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid

Bullous pemphigoid (BP) is the most common blistering auto-immune disease of skin with an incidence estimated to 400 new cases per year. Topical corticosteroid therapy is considered the standard treatment for bullous pemphigoïd in 2002. Topical corticosteroid requires an initial large hospitalization during the acute phase and rehospitalization during relapse. The usefulness of immunosuppressive drugs have suggested by uncontrolled study.

In this way, leflunomide could be an alternative therapy, and to reduce relapse and/or resistance risks.

This study could prove the efficacity of leflunomide, associated with short time topical corticosteroids.

Pre-inclusion stage: Case history, clinical examination, laboratory study, inclusion criteria checking.

Inclusion stage: Inclusion and exclusion criteria checking, clinical examination, disease follow-up, written inform consent.

Ambulatory hospitalisation, laboratory study.

Treatment and follow-up of the patients.

Clobetasol propionate cream application and leflunomide introduction.

After inclusion, the treatment will begin with 40 g topical corticosteroid per day and 20 mg leflunomide per day.

Topical corticosteroids will be progressively decreased during 5 months and stopped.

Follow-up: monthly during one year in the department of dermatology, university hospital (clinical examination, laboratory study).

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 65 years old
* Bullous pemphigoid :

  * Newly diagnosed bullous pemphigoid : No treatment or topical corticosteroids therapy for less than one month
  * BP diagnosed : Resistance of the BP to the treatment or recurrence 6 months at least after diagnosis
* Follow up monthly during one year accepted
* Written Inform Consent

Exclusion Criteria:

* None
The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

this study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relivion®)

The Relivion® is a non-invasive transcutaneous neuro-stimulator is indicated for the acute treatment of migraine with or without aura in subjects 18 years of age or older. The Relivion® is intended to be a prescription device, self-used at home.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 years of age and older.
2. Subject meets the ICHD (International Classification of Headache Disorders)-3 (2018) diagnostic criteria for Migraine with or without aura.
3. Subject reports 1-6 Migraine attacks per month; other headaches no more than 6 days per month.
4. Subject is willing to and capable of complying with the specified study requirements, provided written Informed Consent, can complete the electronic diaries, and can be contacted by telephone.

Exclusion Criteria:

1. Subject having received Botox treatment in the head region in the prior 3 months.
2. Subject having received supraorbital or occipital nerve blocks in the prior month.
3. Past 6 months of chronic migraine, New Daily Persistent Headache, and chronic tension-type headache per ICHD-3 (2018) diagnostic criteria.
4. Current medication overuse headache.
5. Use of opioid medications in the prior 1 month.
6. Use of barbiturates in the prior 1 month.
7. Subject has \>10 headache days per month
8. Implanted metal/shrapnel or electrical devices in the head (not including dental implants), a cardiac pacemaker or an implanted or wearable defibrillator.
9. Received parenteral infusions for migraine within the previous 2 weeks.
10. Subject has known uncontrolled epilepsy.
11. History of neurosurgical interventions
12. Subject with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
13. Current drug abuse or alcoholism.
14. Subject is participating in any other clinical study.
15. Skin lesion or inflammation at the region of the stimulating electrodes.
16. Personality or somatoform disorder.
17. Pregnancy or Lactation.
18. Women with child bearing potential without medically acceptable method of contraception (NOTE: Females of child bearing potential must have a negative pregnancy test).
19. Documented history of cerebrovascular event.
20. Subject with recent brain or facial trauma (occurred less than 3 months prior to this study).
21. Subject participated in a previous study with the Relivion device.
22. The subject does not have the basic cognitive and motor skills needed to operate a smartphone.
23. Subject with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters
24. Subject with other significant pain problem that in the opinion of the investigator may confound the study assessments.
A Study to Evaluate the Efficacy and Safety of HLX07 in nsqNSCLC Patients With High EGFR Expression

An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Combination with Chemotherapy or Monotherapy in Advanced Non-squamous Non-small Cell Lung Cancer (nsqNSCLC) Patients with High EGFR Expression


Eligibility Criteria:
Inclusion Criteria:

1. Age\>=18Y
2. Good Organ Function
3. Expected survival time ≥ 3 months
4. Histologically confirmed, advanced/recurrent or metastatic nsqNSCLC
5. Measurable lesion according RECISTv1.1 by investigator
6. High EGFR expression H score ≥200
7. ECOG score 0-1

Exclusion Criteria:

1. Histologically, squamous NSCLC should be excluded. For tumors with adenocarcinoma and squamous carcinoma, if the adenoid component is dominant and the squamous component is \< 5%, the patients meet the inclusion requirements.
2. Previous treatment with EGFR inhibitors
3. Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
4. Active clinical severe infection;
5. A history of other malignancies within 5 years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin,etal.
Talampanel for Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.


Eligibility Criteria:
Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria.

Inclusion Criteria:

1. Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.
2. Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit.
3. Slow VC test equal to or greater than 70% of the predicted value.
4. The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.
5. Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to screening visit.
6. Ages 18-80 (inclusive)

Exclusion Criteria:

1. The use of invasive or non-invasive ventilation.
2. Subject having undergone gastrostomy.
3. Subject with any clinically significant or unstable medical condition.
4. Subject participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter).
5. Females who are pregnant or nursing.
Immunological Characteristics of a Population at Risk of Cholera After Oral Cholera Vaccine (CHOVAXIM)

The purpose of the study is to find out if individuals who received first and second dose of Oral Cholera Vaccine (OCV) in Lukanga Swamps, Central Province of Zambia have developed protection against future attacks to cholera. The investigators also want to investigate whether vitamin A deficiency and being HIV positive increases the chances of suffering from cholera.

Cholera is caused by toxigenic strains of Vibrio cholerae O1 and O139 and is characterised by sudden onset of acute watery diarrhoea that can lead to severe dehydration and ultimately death if not treated. Zambia, has continued to experience cholera outbreaks in several parts of the country. In order to curb the disease outbreaks, the World Health Organisation (WHO) recommended introducing cholera vaccination as a supplementary cholera control measure together with other prevention and control strategies, in endemic areas as well as in other places at risk for cholera outbreaks. OCV has recently been introduced to Zambia where a large population was vaccinated with 1 dose of Shanchol®, and about 6 months later over 70% individuals traced to receive a second dose.

Considering the annual outbreaks of cholera in Zambia, there is urgent need to determine whether Shanchol® is able to elicit a sufficient and specific immunological response in individuals who received OCV in Zambia. This study will also help the investigator understand whether there are immune response differences based on genetics and may indicate whether some people may need more vaccine regimens than others.

Objective 1: To profile cholera specific antibody status of a population at risk of cholera before and after receiving 1st and 2nd dose of shanchol ® oral cholera vaccine (OCV) Objective 2: To profile and characterize cholera specific B and T lymphocyte phenotypes among the immunized Zambians Objective 3: Develop and evaluate a non-invasive proxy measure of OCV immune responses Objective 4: To measure the protective value of immunizing HIV-infected individuals through measurement of the neutralization capabilities OCV generated antibodies Objective 5: To assess the impact of ABO blood groups on cholera antibody generation

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18-65 years are eligible to participate.
* Participant is a resident of the study area. Residence was defined as individuals living in the study area for the past 1 year.
* Written consent provided by participant.

Exclusion Criteria:

* Participant aged less than 18 years
* Refuses to consent to participate
* Pregnancy
* Participant has acute medical illness prior to receipt of oral cholera vaccine -Participant has a history of hospitalization for cholera in the past one week
Impact of Sunscreen Dispensers in Parks Visited by Teenagers

This study will evaluate the use of publicly available free sunscreen dispensers at Maine beaches and Boston and Cambridge parks.

Aim 1: Determine the impact of DFS+ (dispensers, flyers, enhanced signage, + a social media component delivered by teen ambassadors) sun protection education on the use of free sunscreen dispensers by adolescents ages 12-20 compared with DFS (dispensers, flyers, standard signage).

Aim 2: Outcomes evaluation to assess the effects of the sunscreen dispensers and the sun-safety educational intervention on sun protection knowledge, attitudes, beliefs, and behaviors within the community.

Aim 3: Cost Evaluation and Cost-Effectiveness Analysis

The investigators will build on the pioneering work of IMPACT Melanoma which has provided free sunscreen dispensers to a general population. This study will build on IMPACT Melanoma's ability to install, maintain, and now for the first time, target and publicize the use of dispensers for a teen population. The investigators will test scalable methods for improving the use of free sunscreen dispensers by testing DFS interventions compared with the addition of social media led by teen ambassadors. The investigators will evaluate the impact of the intervention in both parks and beaches in Boston, MA, Cambridge, MA and Maine.

Eligibility Criteria:
Inclusion Criteria:

* Being a Boston, MA, Cambridge, MA or Maine youth ages 12-20
* Able to complete a survey in English

Exclusion Criteria:

* Not a Boston, MA, Cambridge, MA or Maine youth ages 12-20
* Not able to complete a survey in English
A Study of Subcutaneous HUMIRA (Adalimumab) Injection to Assess Adverse Events and Change in Disease Activity In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective Humira (adalimumab) is in treating moderately to severely active CD in China. Adverse events and change in disease activity will be assessed.

Humira (adalimumab) is a drug approved for the treatment of Crohn's disease (CD).All study participants will receive Humira as prescribed by their study doctor in accordance with approved local label. Approximately 252 participants will be enrolled in China.

Participants will receive subcutaneous HUMIRA (adalimumab) injection as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for 1 year.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants meet the diagnosis of moderate to severe Crohn's disease.
* Participants prescribed with Humira, under investigators' sufficient consideration of benefits/ risks per local label.

Exclusion Criteria:

* Participants who have any of the contraindications as per adalimumab (Humira) label in China.
* Participants who are allergic to any component of adalimumab (Humira).
* Participants with active hepatitis B diagnosed.
* Participants with severe active infection, or known history of active or latent tuberculosis (TB), or latent TB infection with inadequate treatment.
* Participants with cancer diagnosed, excluding also those with non-melanoma skin cancer (NMSC) completely treated, per local label.
* Participants with moderate to severe heart failure.
* Participants who are unwilling to participate, or not suitable for participation as judged by the investigator at risk of noncompliance to study procedure.
* Participants who are enrolled to other interventional studies.
* Participants who are prescribed with adalimumab but choose Humira bio-similar in China.
Hemodialysis and Wanting for Protein-rich Foods

A study conducted in the laboratory revealed the existence of a "window" during which patients with renal failure appreciate the protein-rich foods. This period, located immediately after the dialysis, is likely related to the purification of plasma products resulting from protein catabolism. It therefore appears necessary to understand the mechanisms that may explain these changes by measurements of ghrelin (orexigenic hormone), leptin (anorectic hormone) and plasma amino acids.

In 24 patients with renal failure treated by hemodialysis, it is evaluated (at 8:00 am and at 11:00 am), a day without hemodialysis and another day after the hemodialysis:

* Hunger sensation,
* Olfactory liking assessed separately for 6 foods (2 carbohydrate-, 2 fat- and 2 protein-rich foods) and 2 non-alimentary products,
* Food wanting evaluated by the sequential presentation of 18 images of food (6 fat-, 6 carbohydrate- and 6 protein-rich foods),
* Two blood samples for the assays of leptin, ghrelin, creatinine, albumin and pre-albumin as well as plasma amino acids.

  24 healthy subjects are also evaluated in order to compare the results from patients to those of control subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients and healthy subjects were included if they were aged between 18 and 80 years

Exclusion Criteria:

* diabetes, advanced undernutrition (BMI \< 17.5 kg m-2, prealbumin \< 250 mg.L-1), congestive heart failure, acute or chronic infection, ongoing antibiotic treatment, active cancer, liver cirrhosis, smoking (more than 5 cigarettes/day), alcohol consumption (more than 3 units/day), aversion to the foods eaten or smelt during the study, impaired comprehension of the cognitive tasks
Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control

The primary objective of this study is to determine whether the route of administration of naproxen (either by mouth or rectally) influences post-vaginal delivery perineal pain control.

Postpartum perineal pain is common after vaginal delivery. Naproxen suppositories have been shown to be effective at reducing postpartum perineal pain. To date, no studies have investigated the efficacy of oral naproxen for perineal pain control. Currently, rectal naproxen is used postpartum because of an assumption that there is a "local effect" compared to oral administration. However, this effect has never been documented in the literature.

Principles of pharmacology dictate that the least invasive route of drug administration should be used when two or more routes are equally effective. If oral and rectal naproxen are equally efficacious at controlling post-vaginal delivery perineal pain, then current practice would be challenged.

The primary objective of this study is to determine whether the route of administration of naproxen influences post-vaginal delivery perineal pain control. Pain scores will be measured using a visual analog scale. The secondary outcome measures are three-fold: patient preference of route of administration, medication adverse effects, and additional requests for analgesia. The working hypothesis is that there is no difference in pain control between oral and rectal administration and that patients will prefer the oral route.

Eligibility Criteria:
Inclusion Criteria:

* Potential volunteers who meet all of the following criteria are eligible for this study:

  1. Active labor, whether spontaneous or induced
  2. Age between 18 and 40 years old
  3. Nulliparous
  4. BMI \< 40
  5. Single live intrauterine fetus in cephalic presentation
  6. Term gestation (370 weeks to 416 weeks inclusive) as defined by ultrasound or last menstrual period dating
  7. Intrapartum epidural labour analgesia
  8. Written informed consent

Exclusion Criteria:

* Potential volunteers meeting one of more of the following criteria may not be enrolled:

  1. Medical conditions including:

     1. Naproxen, aspirin or other non-steroidal anti-inflammatory drug hypersensitivity
     2. Asthma
     3. Peptic ulcer disease or other inflammatory gastrointestinal disease
     4. Renal, hepatic or cardiac disease
     5. Coagulopathy
     6. Rectal or anal pathology including recent (within 1 month) rectal bleeding
     7. Prescribed medications including lithium, furosemide, antihypertensives, anticoagulants, aminoglycosides, hydantoins, or sulfonamides
  2. Obstetrical conditions including:

     1. Multiple pregnancy
     2. Extensive perineal trauma (third or fourth degree laceration)
     3. Forceps delivery
     4. Cesarean section delivery
     5. Paracervical or pudendal nerve blocks
     6. Vulval or vaginal hematomas
  3. Nulliparous women not requiring intrapartum epidural labour analgesia
Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations

This is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Resectable non-small cell lung cancer harboring driver gene mutations.
* At least one measurable disease based on Response Evaluation Criteria in Solid Tumors 1.1.
* Have adequate organ function.
* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication；Females should not be breastfeeding；Female subjects of childbearing potential as well as males sexually active with women of childbearing potential must be willing to use an adequate method of contraception.
* Voluntarily comply with the treatment protocol.

Exclusion Criteria:

* Previously treated with any anti-tumor therapy;
* Subject with known autoimmune disease
* Subject with known history of testing positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS), subject has known active hepatitis B or C.
* Presence of third space effusion that cannot be controlled by drainage or other means (e.g., excessive pleural fluid and ascites).
* Subject with severe liver and kidney dysfunction.
* Subjects who need to use corticosteroids (\>10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressive therapy for systematic treatment within 14 days before the first administration of the study
* Subject with previous malignancies within 5 years, except for cured in situ cancer.
* Subject with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia and severe damage to lung function.
* Subject with uncontrolled hypertension.
* Prior organ transplantation including allogenic stem-cell transplantation.
* Known hypersensitivity to the study drug or any of its excipients.
* Other situations that the investigator considers unsuitable for the enrollment.