cyrilzakka/clinical-trials huggingface dataset:
Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome

This Phase 3 study is designed to test the effectiveness of intranasal carbetocin (LV-101) in participants with Prader-Willi syndrome (PWS). Carbetocin is an oxytocin analog (a man-made chemical that is like oxytocin). This study will also evaluate the safety and tolerability of LV-101.

This is a Phase 3 randomized, double-blind study with an 8-week, placebo-controlled period designed to test the effectiveness, safety, and tolerability of LV-101 in participants with PWS.

Effectiveness will be measured using both caregiver-reported and clinician-reported measures of hyperphagia (extreme hunger), obsessive and compulsive behaviors, and anxiety. Safety and tolerability will be measured by adverse events, laboratory tests, and physical exams.

After the 8-week placebo-controlled period, there will be a long-term follow-up period of 56 weeks and an optional extension period after study week 64 during which all participants will receive active treatment with LV-101. At Week 8, participants who were randomized to placebo in the placebo-controlled period will be randomized to one of the two LV-101 doses, administered three times per day before meals.

Eligibility Criteria:
Inclusion Criteria:

* Genetically-confirmed Prader-Willi syndrome
* Provide voluntary, written informed consent (parent(s) / legal guardian(s) of participant); provide voluntary, written assent (participants, as appropriate)
* PWS Nutritional Phase 3 (hyperphagic, rarely feels full)

Exclusion Criteria:

* Living in a group home
* Genetically diagnosed Schaaf-Yang syndrome or other genetic, hormonal, or chromosomal cognitive impairment
* New food-related interventions, including environment or dietary restrictions, within 1 month of screening
* Dose of any allowed chronic concomitant medications or supplements that have not been stable for ≥3 months prior to the study or is not expected to remain stable while participating in the study; adjustments in growth hormone dose ≤10% are not exclusionary
* Presence of cardiovascular disorders, epilepsy, frequent migraines, or severe asthma
* More than 3 episodes of sinusitis in the 12 months prior to Screening Visit or presence of nasal diseases that may affect deposition of intranasal medication
* Unwilling to abstain from nasal saline, other nasal irrigation, or other intranasal medications for 2 weeks prior to the Baseline visit and during the 8-week, placebo-controlled period of the study
* Use of weight loss medication, oxytocin, carbetocin, or vasopressin in the 6 months prior to screening
* Participation in an interventional research study involving another investigational medication or device in the 6 months prior to screening or during the study
* Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to unstable medical condition, inability to comply with the protocol, or other risk to subject or to the integrity of the study
Web-Based Adolescent Motivational Enhancement Study

The proposed study is a randomized controlled trial that compares the effectiveness of an electronic personalized health screening app incorporating motivational feedback (i.e. "Check Yourself") to usual care among moderate to high risk alcohol users. The purpose of this study is to determine whether Check Yourself is more effective than usual care in reducing alcohol consumption and binge drinking and improving quality of care among adolescents receiving school-based health clinic services.


Eligibility Criteria:
Inclusion Criteria:

* Eligible individuals will be 13-18 years old who are able to read and comprehend English.
* Participants who indicate alcohol use consistent with moderate to high risk on the Check Yourself App.

Exclusion Criteria:

Individuals will be excluded from the study if:

* They do not meet age requirements
* Do not have a study visit at a participating school-based health clinic
* Lack the means to complete follow-up interviews (i.e. have neither telephone or internet access)
* Are not able to read or comprehend English
Effect of Acupuncture for QoL in Gastric Cancer Patients Undergoing Adjuvant Chemotherapy: a Pilot Study

This is a pilot study evaluating the efficacy of acupuncture on quality of life in gastric cancer patients undergoing postoperative adjuvant chemotherapy. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or none-acupuncture during the first 3 cycles of adjuvant chemotherapy after resection.


Eligibility Criteria:
Inclusion Criteria:

* 1.Pathologically diagnosed with gastric cancer or esophagogastric junction cancer after R0 resection and D2 lymph node dissection;
* 2.Pathological stage II or stage III；
* 3.Without tumor recurrence confirmed by image examination;
* 4.No chemotherapy after surgery, planning to accept at least 3 cycles of adjuvant chemotherapy;
* 5.Age:18\~75 years old；
* 6.ECOG score≤ 2；
* 7. Normal organs function, including: 7.1 Bone marrow function: absolute neutrophil count (ANC)≥1.5×10e9/L, platelet (PLT)≥100×10e9/L,hemoglobin (Hb)≥90g/L; 7.2 Kidney function: Serum creatinine (Scr)≤1.5mg/dl(133μmol/L), or creatinine clearance rate (Ccr)≥60ml/min； 7.3 Liver function: Total bilirubin (TB)≤1.5×upper limit of normal value (ULN), Alanine transaminase (ALT)≤2.5×ULN, Aspartate transaminase (AST)≤2.5×ULN；
* 8. Can understand the study well and finish the questionnaires in this study;
* 9. With the written informed consent.

Exclusion Criteria:

* 1. Can not finish the baseline assessment;
* 2. Needle phobia;
* 3. Currently diagnosed with psychiatric disorder (e.g., severe depression, obsessive-compulsive disorder, or schizophrenia);
* 4. History of autoimmune diseases, hematological diseases or organ transplantation, or long term use of hormones or immunosuppressors;
* 5. Implanted with heart pacemaker;
* 6. Has accepted neoadjuvant radiotherapy before surgery;
* 7. Planning to accept adjuvant radiotherapy after surgery;
* 8. With active infection;
* 9. Acupuncture treatment within the previous 6 weeks;
* 10.Pregnant or lactating women.
Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo

This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic


Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
* Male
* Aged 18 - 65
* Weight 50kg+, BMI 19-32 kg/m2
* Exhibit response to Challenge Chamber and skin prick test.
* Non-smoker
* Capable of giving informed consent

Exclusion Criteria:

* No nasal structural abnornmality/polyposis, surgery, infection.
* any respiratory disease, other than mild asthma or seasonal allergic rhinitis
* participated in another clinical study within 30 days.
* Subject has donated a unit of blood within 1 month
* Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
* History of sensitivty to drug
* History of alcohol/drug abuse within 12 months.
* Positive Hepatitis B antibody test
* Positive HIV antibody test
* Risk of non-compliance with study protocol
* Perenial allergic rhinitis
* Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
* Past or present disease that may affect outcome, as judge by investigator Specific Immunotherapy within 2 years
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia

The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).

This trial was designed to evaluate the effect of IV iron isomaltoside/ferric derisomaltose compared with IV ferric carboxymaltose on s-phosphate in subjects with IDA caused by different etiologies.

The subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or two IV doses of ferric carboxymaltose (one dose 750 mg at baseline and a second dose 750 mg on day 7; cumulative dose: 1500 mg). The study subjects were monitored for up to 35 days from baseline.

Eligibility Criteria:
Inclusion criteria include:

* Subjects having IDA caused by different aetiologies
* Haemoglobin (Hb) ≤ 11 g/dL
* Body weight \> 50 kg
* Serum ferritin (S-ferritin) \< 100 ng/mL
* Estimated Glomerular Filtration Rate (eGFR) ≥ 65 mL/min/1.73 m2
* Serum phosphate (S-phosphate) \> 2.5 mg/dL
* Intolerance or unresponsiveness to oral iron
* Willingness to participate and signing the Informed Consent Form (ICF)

Exclusion criteria include:

* Acute bleeding \> 500 mL within 72 hours
* Anaemia predominantly caused by factors other than IDA
* Hemochromatosis or other iron storage disorders
* Previous serious hypersensitivity reactions to any IV iron compounds
* Treatment with IV iron within the last 30 days prior to screening
* Treatment with erythropoietin or erythropoietin-stimulation agents
* Red blood cell transfusion, radiotherapy, and/or chemotherapy
* Received an investigational drug within the last 30 days prior to screening
* Planned surgical procedure within the trial period
* Hepatic enzymes \> 3 times upper limit of normal
* Surgery under anaesthetic within the last 30 days prior to screening
* Any non-viral infection within the last 30 days prior to screening
* Alcohol or drug abuse within the past 6 months
* Vitamin D deficiency
* Untreated hyperparathyroidism
* Kidney transplantation
* Active malignant disease, disease-free for less than 5 years
* History of a psychological illness or seizures
* Pregnant or nursing women.
Patient Understanding (Cognitive Debriefing) of a Daily Diary of Gastroparesis Symptoms

The primary objective of the study is to evaluate how patients with gastroparesis interpret the instructions, item content, and response options of a daily diary questionnaire designed to assess the key symptoms of gastroparesis.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has Type 1 or Type 2 diabetes mellitus
2. Subject is 18 to 70 years old
3. Subject has chronic, active symptoms of gastroparesis for at least the past three months
4. Subject has confirmed delayed gastric emptying by scintigraphy, a breath test, or the SmartPill® wireless motility capsule
5. Subject can speak and read English
6. Subject is able to give his/her informed consent

Exclusion Criteria:

1. Subject has a cognitive, psychological or other (e.g., visual) impairment that would interfere with completing the study visit

-
Intralymphatic Immunotherapy in Increasing Doses, Substudy

The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.

\*\*\*IMPORTANT INFORMATION!\*\*\* The up-dosing protocol is changed due to adverse events at 5000 SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.

40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval.

Eligibility Criteria:
Inclusion Criteria:

* Seasonal allergic symptoms for birch and/or grass verified by skin prick test,
* Accepted informed consent

Exclusion Criteria:

* Pregnancy or nursing
* Autoimmune or collagen disease (known)
* Cardiovascular disease
* Perennial pulmonary disease
* Hepatic disease
* Renal disease
* Cancer
* Any medication with a possible side-effect of interfering with the immune response
* Previous immuno- or chemotherapy
* Chronic diseases
* Other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease)
* Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)
* Major metabolic disease
* Known or suspected allergy to the study product
* Alcohol or drug abuse
* Mental incapability of coping with the study
* Withdrawal of informed consent
HPV Vaccine Acceptability Among Young Men Who Have Sex With Men

The FDA has recently approved Gardasil for the prevention of anal cancer in people aged 9-26. Men who have sex with men (MSM) have disproportionately high rates of anal cancer and could benefit greatly from vaccination. Vaccine uptake among young MSM (YMSM) is poor, and little is known about factors associated with vaccine acceptance in this population. With the risk of anal cancer among MSM higher than the risk of cervical cancer among women before routine cytological screening was introduced, acceptance of a prophylactic vaccine in this subgroup is the most cost-effective and attainable strategy to greatly reduce the prevalence of anal cancer. While the investigators can assume the human papillomavirus (HPV) vaccine has many acceptable concepts among these men, there are multiple barriers which may potentially interfere with their likelihood of initiating the vaccine series. Vaccine catch-up rates among women of a similar age has been poor, and there is no reason to expect this to be higher among men. One potential strategy to increase vaccine uptake in this catch-up group is to implement a patient-driven program to promote vaccination among men.

This project will contribute to the investigators understanding of how the investigators can utilize social networks to identify barriers to HPV vaccination among YMSM, and how to potentially influence a patient-driven vaccination effort to increase uptake among men in the catch-up age group. This research will inform future interventions to targeted populations that may be incorporated into online social networking websites to encourage HPV vaccination.


Eligibility Criteria:
Inclusion Criteria:

* 18-26 years old
* male

Exclusion Criteria:

* younger than 18 years old
* older than 26 years old
* female
CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Acute Myocardial Infarction II (COREA-AMI II)

This study is intended to provide contemporary data on the residual cardiovascular risk in all consecutive patients with acute myocardial infarction, especially in patients who survived stably within one-year after percutaneous coronary intervention.

In addition, this study will identify which baseline clinical, angiographic, or treatment factors are associated with residual cardiovascular risk and bleeding events

COREA-AMI registry was conducted previously (NCT02385682) and enrolled consecutive all patient with acute myocardial infarction who were treated with percutaneous coronary intervention from Jan 2004 to Dec 2009.

COREA-AMI II registry extend the enrollment period to Aug 2014 and the follow-up period to Jun 2016.

All consecutive acute myocardial infarction patients had been enrolled prospectively in prior registries of each university hospitals. Eight hospitals of the Catholic University of Korea already have web-based coronary intervention registry (NCT01239914). And Cheonnam University Hospital is one of leading hospitals to design and manage the web-based previous Korean nationwide myocardial infarction registry, the Korea Acute Myocardial Infarction Registry (KAMIR) (http://www.kamir.or.kr/).

Using these previous data, the current registry update new clinical and angiographic variables and assess long-term clinical follow-up data retrospectively. All data were collected on web-based system after eliminating personal information. (http://www.ecrf.kr/coreaami/)

All data are going to be sealed with code by Clinical Research Coordinating Center of the Catholic University of Korea and to be managed and analyzed by independent statistics perssonels.

Cardiovascular center with high-volume percutaneous coronary intervention of following hospitals were participated.

* Seoul St. Mary's Hospital, Seoul, South Korea
* Yeoido St. Mary's Hospital, Seoul, South Korea
* Uijongbu St. Mary's Hospital, Gyeonggi-do, South Korea
* St. Paul Hospital, Seoul, South Korea
* Bucheon St. Mary's Hospital, Gyeonggi-do, South Korea
* Incheon St. Mary's Hospital, Incheon, South Korea
* St. Vincent Hospital, Gyeonggi-do, South Korea
* Deajon St. Mary's Hospital, Daejeon, South Korea
* Cheonnam University Hospital, Gwangju, South Korea

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction who were treated with percutaneous coronary intervention using stents

Exclusion Criteria:

* Acute myocardial infarction who were treated with only balloon angioplasty
* Acute myocardial infarction who were managed by conservative strategy
Effects of Pranayama Breathing Technique in Patients With Chronic Obstructive Pulmonary Disease

It will be randomized controlled trial. The research will be conducted at Bahawal Victoria hospital Bahawalpur and civil hospital Bahawalpur. We take 60 patients (Epitool), Patients will be allocated randomly in two groups. Group A will get conventional medical treatment and Group B will get both conventional medical treatment and pranayama breathing exercise. Both gender of age group 30 to 55, Patient with diagnosed Chronic obstructive pulmonary disease ,Moderate to severe Chronic obstructive pulmonary disease with productive cough, Shortness of breathe and no surgical procedure performed will be included in this study. And patients of lung surgery, lung cancer, above 70 years age, with open wound, cardiovascular issues, and neurological issues will be excluded. Yoga exercise pranayama, 6 min walk test, IPAQ- quality of life and VSAQ-exercise capacity will be used as tools. Data will be analyzed on SPSS 21.

It will be randomized controlled trial. After approval of synopsis the research will be conducted at Bahawal Victoria hospital Bahawalpur and Sadiq abbasi hospital Bahawalpur. Written informed consent will be obtained. We take 60 patients (Epitool), Patients will be allocated randomly in two groups. Group A and group B. Group A will get conventional medical treatment and Group B will get both conventional medical treatment and pranayama breathing exercise. Both gender of age group 30 to 55, Patient with diagnosed COPD, Moderate to severe COPD with productive cough, SOB and no surgical procedure performed will be included in this study. And patients of lung surgery, lung cancer, above 70 years age, with open wound, cardiovascular issues, and neurological issues will be excluded. Yoga exercise pranayama, 6 min walk test, IPAQ- quality of life and VSAQ-exercise capacity will be used as tools. Data will be analyzed on SPSS 21.

Eligibility Criteria:
Inclusion Criteria:

* Both gender of age group 30 to 55

  * Patient with diagnosed COPD.
  * Moderate to severe COPD.
  * Patient with productive cough and SOB.
  * No surgical procedure perform.

Exclusion Criteria:

* Patient of lung surgery

  * Lung cancer patient
  * Patient above 70 years age.
  * Patient with open wound.
  * Patient with cardiovascular issues
Impact of Angiotensin Converting Enzyme Activity on Exercise Training Sensitivity

The phenotype based on the insertion/deletion (I/D) polymorphism of the human angiotensin converting enzyme (ACE) gene has been associated with individual training response. Briefly, intervention studies have demonstrated an 11-fold greater training-induced improvement in muscular endurance for ACE I/I homozygotes compared to ACE D/D homozygotes.

Importantly, the ACE I/D polymorphism causes large inter-individual differences in serum ACE activity. Because the ACE D/D genotype is characterized by high plasma ACE activity and potentially blunted endurance exercise training response, it appears likely that ACE inhibitors (ACEi) have the potential to improve the outcome of exercise training for ACE D/D homozygotes.

Thus, in the present study the investigators apply a randomized double-blind placebo-controlled longitudinal design to investigate whether pharmacological inhibition of ACE activity can amplify the exercise training response in healthy humans carrying either the ACE D/D or ACE I/I genotype.

The study hypothesis is that inhibition of ACE activity in healthy humans with the ACE D/D genotype will amplify the health beneficial effects of exercise training while this is not the case in ACE I/I homozygotes.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20-50 years
* Healthy

Exclusion Criteria:

-
Incidence of Brachial Plexus Injury After Rotator Cuff Repair With Continuous Interscalene Block

Brachial plexus injury after shoulder surgery with continuous interscalene block is 2.4% at 1 month and 0% at 6 months, but may be higher with a systematic postoperative neurological examination. Indeed, femoral neuropathy after anterior cruciate ligament reconstruction is 24% at 6 weeks in a cohort of 20 consecutive patients systematically screened with an electromyogram. Brachial plexus injury may be the consequence of the surgery (direct lesion by traction) or the continuous interscalene block. The goal of this study is to define the etiology of this postoperative neuropathy.

Rotator cuff surgery is associated with moderate to severe postoperative pain. Among different analgesic strategies, continuous interscalene block is reported to be an efficient method, reducing opioid consumption and allowing rapid rehabilitation; however, patients may develop a transient neuropathy after surgery, which could have a significant impact on active patients. This study is designed to compare the incidence of brachial plexus injury in two groups of patients: one with a continuous interscalene block, and one with a patient control analgesia of morphine (self-iv administration of morphine). All patients will have a clinical neurological exam with a preoperative electromyogram in order to rule out a pre-existing neuropathy. Another clinical neurological exam with electromyogram will be performed between 4 and 6 postoperative weeks and, if pathological repeated at 6 months, 9 months and 12 months. The surgery will be done under general anesthesia for all patients.

Eligibility Criteria:
Inclusion Criteria:

* patients planned for rotator cuff repair
* ASA 1, 2 and 3
* age 16 years and more

Exclusion Criteria:

* peripheral neuropathy
* pre-existing brachial plexus injury
* diabetes mellitus
* alcoholism
* drug addiction