cyrilzakka/clinical-trials huggingface dataset:
Effect of Oxytocin on Craving and Therapy Response

The purpose of this study is to examine the impact of a medication called oxytocin on marijuana use and therapy response in people who frequently use marijuana.

Oxytocin has been shown to promote trust, social bonding, and calmness; however, its potential additive effects with a therapy intervention have not been explored in marijuana-dependent individuals. In the proposed study, the impact of intranasal oxytocin on therapy effectiveness and marijuana use outcomes following a brief therapy intervention will be investigated. It is hypothesized that oxytocin administration (vs. placebo) will improve treatment satisfaction and decrease marijuana use.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
2. Subjects must meet DSM-IV criteria for current marijuana dependence (within the past three months). While individuals may also meet criteria for abuse of other substances, they must identify marijuana as their primary substance of abuse and must not meet criteria for dependence on any other substance (except nicotine) within the last 60 days.
3. Subjects must consent to remain abstinent from alcohol for 24 hours and other drugs of abuse (except nicotine and marijuana) for three days immediately prior to study procedures. Subjects must abstain from marijuana for 24 hours prior to testing. By restricting marijuana use as proposed, subjects should not be under the acute effects of marijuana.
4. Subjects must consent to random assignment.

Exclusion Criteria:

1. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
2. Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect physiological/subjective responses.
3. Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
4. Subjects who pose a current suicidal or homicidal risk.
5. Subjects taking any psychotropic medications, including SRI's or other antidepressants, opiates or opiate antagonists because these may affect test response. Individuals who take stimulants for treatment of ADHD will be allowed to participate.
6. Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
7. Subjects who are unwilling or unable to maintain abstinence from alcohol and marijuana for 24 hours and other drugs of abuse (except nicotine) for three days prior to study procedures.
8. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or marijuana) within the past 60 days.
9. Subjects who, in the investigator's opinion, would be unable to comply with study procedures or assessments.
P3: Pacemaker Patient Profiling Study

The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers.


Eligibility Criteria:
Inclusion Criteria:

* Patient meets Class I / Class II indications for pacing
* Patient implanted with one of the following market-approved single or dual chamber Medtronic devices: EnRhythm™, EnPulse®, Kappa® 700, Kappa® 900, Vitatron Clarity™, Vitatron Selection® AFm, Vitatron C-Series, Vitatron T-Series, or the AT500™ DDDR Pacing System

Exclusion Criteria:

* Patient is enrolled in a device or cardiovascular drug study that affects treatment and/or study device programming
* Patient whose life expectancy is less than two years
Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Biliary Atresia

Biliary atresia (BA) is the most frequent cause of chronic cholestasis in neonates, accounting for at least 50% of pediatric liver transplantation. BA incidence is estimated to range from 1:5000 to 1:19000 live births. All patients will die due to complications of liver cirrhosis if the operation is not performed. Recently, mesenchymal stem cell (MSC) transplantation has been found as a promising therapy for liver cirrhosis in adults. Bone marrow-derived stem cell transplantation was also performed successfully for children with BA. Compared to MSC isolation from bone marrow, isolating MSCs from umbilical cord (UC) tissue is a less invasive procedure.

Furthermore, UC-derived MSCs (UC-MSCs) have been demonstrated to be safe and effective for liver cirrhosis in adults and different pediatric diseases, including liver cirrhosis due to primary biliary cirrhosis. The investigators will compare the outcomes of 17 Kasai operated BA patients who receive UC-MSC transplantation to 17 BA patients who only undergo Kasai operation. Two transplantations of UC - MSCs will be performed via the hepatic artery: the first transplant will be performed at baseline, and the second one will be performed 6 months later with a dosage of 1 million MSCs per kg of body weight. The frequency and severity of the adverse events or serious adverse events associated with UC-MSC injection at 72 hours post-injection will be used to assess the safety. The efficacy of the therapy will be measured using Pediatric End-Stage Liver Disease (PELD) score, liver function, and liver biopsy. This study would open a novel cell therapy to improve outcomes of patients with BA.

The study protocol was approved by the Vinmec International Hospital Ethics Committee, and National Ethics Committees. The stem cell products are conducted in accordance with (GMP) requirements and Good Clinical Practice (GCP). All patients and primary caregivers will receive a written consent form, a cover letter and a clear explanation of the safety issues, potential risks and benefits, and the procedure involved. Moreover, patients will be provided the updated results related to disease and the study during conducting the study and will be fully funded by the project.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with liver cirrhosis due to biliary atresia after Kasai's operation
* From 5 months to 2 years old
* Weight ≥ 6 kg
* Patients with manifestation of cirrhosis on liver biopsy during Kasai's operation.
* Parents or primary caregivers signed the informed consent form.

Exclusion Criteria:

* Under 6kg or over 2 years old
* Coagulation disorders
* Allergy to anesthetic agents
* Active infections
Spa Effects After Exercise

The aim of this study is to evaluate the recovery effect of Spa therapy after aerobic exercise in cardiovascular, performance and perceived fatigue. A pragmatic controlled repeated measures, single-blind, trial is conducted. Thirty-four recreational sportspeople are required to visit a Sport-Centre and are assigned to a Spa-therapy or rest in a bed (control group) after complete a spinning session.

Subjects perform the recovery session after completing the exercise protocol. Participants are allocated to the control or intervention group following an order of arrival to the study.

The spinning session is performed using the same protocol for all participants after 24h physical rest. They were asked to perform this session as a regular spinning class. The session is carried out in the afternoon (room temperature 22±3.5°C) on a modified spinning bike (Keiser®, M3). They are allowed to drink water during the session and performed the test, while they listen a compilation of music that lasted 50min composed of 9 tracks.

Each track corresponds to a specific phase of the spinning session. The phases being labeled as warm-up, sitting, seated climbing, jumping, and running, based on the official spinning program manual. Some phases are repeated during the session, the compilation being purposely designed for beginner practitioners of a spinning class. In addition to the music protocol, the participants are asked to maintain a pedal stroke cadence that had previously been established for each track. For the resistance applied to the flywheel, the participants are free to adjust it according to their sensation and interpretation of the spinning session.

Recovery Procedures

A cycle of 3 Vichy shower and whirlpool baths are applied during 30-minutes period. Vichy sedative shower are applied for 90-120 sec to the sides of the trunk and the abdomen, avoiding as much as possible the gall bladder area, at a temperature of 36-38ºC. A short, partial jet spray followed the shower. A whirlpool bath is administered where subjects immersed the body until their clavicle level for a 10min period with a water temperature ranging 33.5-35.5 ºC. Aromatherapy application using lavender and chamomile oils is used in all Spa therapy sessions.

The control group performed a rest session in supine position in a room with neutral temperature condition with a same duration to Spa session. Participants of both groups are encouraged to drink water "ad libitum" to prevent dehydration.

Eligibility Criteria:
Inclusion Criteria:

* 5-10 hours/wk of physical activity, no pharmaceutical drug intake in the past 3 months,
* No use of tobacco or other addictive substances,
* No pain symptoms from at least one year,
* No contradiction for high-intensity exercise following previous study about recovery after exercise

Exclusion Criteria:

* Signs or symptoms of medical disease
Validation of a French Version of the PISQ-R

The main objective of this study is to perform the linguistic validation of the french version of the PISQ-R questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.

Step 1: Establish a French translation of the original questionnaire (English\> French.

Step 2: Perform a first set of comprehension tests with a panel of 15 patients.

Step 3: Establish a revised questionnaire.

Step 4: Perform a second series of comprehension tests with a panel of 10 other patients.

Step 5: Determine the final questionnaire.

Step 6: Perform a back-translation (French\> English.

Step 7: Send the final version of the questionnaire and the questionnaire back-translated to the specific committee of the IUGA for final approval.

Eligibility Criteria:
Inclusion Criteria:

* The patient is able to read and understand French
* The patient must be insured or beneficiary of a health insurance plan
* Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Exclusion Criteria:

* Patient is pregnant
* The patient is under judicial protection, under tutorship or curatorship
* The patient does not understand French
De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma

This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.

A total of 70 patients with HCC (mean age: 54.6 years, female/male: 12/58) received a liver transplant and were included in the study. Immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with hepatocellular (HCC) carcinoma receiving liver transplant

Exclusion criteria:

* Patients less than 18 years of age
Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery

Study of efficacy of adipose derived mesenchimals stem cells and surgery to treat complex perianal fistula

Eligibility Criteria:
Inclusion Criteria:

1. Signature of informed consent.
2. Complex perianal fistula cryptoglandular. Understood as a fistula in which at least one of the following circumstances is present:

   * some degree of fecal incontinence associated
   * extrasphinterics fistulas,
   * fistulas supraresfinterianas
   * high transsphincteric fistulas.
3. Patients of both genders, with more that 18 years.
4. Good overall health, according to data from the clinical history and physical examination.

Exclusion Criteria:

1. Patient diagnosed with inflammatory bowel disease.
2. Subjects with abscess, except if a complete cleaning of the drainage area of collections is performed and the absence of abscess and other collections larger than 2 cm in maximum diameter before treatment is started is confirmed.
3. History of alcohol or substance abuse in the 6 months prior to inclusion.
4. Malignancy, except in the case of basal cell carcinoma or squamous cell skin or a history of malignancy, unless they have been found in remission during the previous 5 years.
5. medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study.
6. Subjects with congenital or acquired immunodeficiencies. Treponema, Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion.
7. Major surgery or severe trauma of the subject in the previous semester.
8. Pregnant or lactating women.
9. Adult women of childbearing potential not using effective contraception during the trial.
10. Administration of any investigational drug at present to three months prior to enrollment for this trial.
Anesthetic Approaches for Dacryocystorhinostomy Surgery: The Effect of Adding Local Anesthesia to General Inhalational Anesthesia

To Study the effect of combination of of general anesthesia and local anesthesia in anesthesia for external dacryocystorhinostomy and assess quality of the procedure

* calculate the total requirement for anaesthetic agents to maintain satisfactory operating conditions
* calculate total anesthetic time
* assess intraoperative changes in hemodynamics
* assess intraoperative blood loss
* evaluate surgeon and patient satisfaction
* recognize whether this was related with changes in postoperative analgesia .
* Also occurrence of postoperative nausea was recorded and compared with general anaesthesia combined with intravenous opioid for (EXT-DCR) surgery.

Eligibility Criteria:
Inclusion Criteria:• Age from 20 to 50 years old.

* American society of anesthesiologists (ASA) physical status I or II.
* Elective unilateral Dacryocystorhinostomy with paranasal skin incision.

Exclusion Criteria:

* Endoscopic Dacryocystorhinostomy.
* Allergy to amide local anesthetics or opioids.
* Drug abuse.
* Pregnancy.
Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

Endovascular thrombectomy (EVT) has become the standard of care for large vessel occlusion in acute ischaemic stroke (AIS). During clot-retrieval, simultaneous balloon inflation within the internal carotid artery offers transient proximal blood flow arrest, potentially preventing distal clot migration or embolisation to new vascular territories. Retrospective studies indicate that this may improve complete vessel recanalisation rates and may translate to improved functional independence. However, lack of high-quality evidence demonstrating the efficacy of simultaneous balloon inflation has led to clinical equipoise with heterogeneity of practice globally.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Acute ischemic stroke presenting with a neurological deficit of (NIHSS ≥2)
* Intracranial arterial occlusion of the distal internal carotid artery or middle cerebral artery (M1/M2 segments) demonstrated with on clinical neuroimaging such as: computed tomography angiogram (CTA), magnetic resonance imaging angiogram (MRA), or digital subtraction angiography (DSA).
* ASPECTS score of \>4 or by locally accepted ischaemic core/penumbra mismatch using computed tomography perfusion or magnetic resonance (CTP or MR) imaging.
* modified Rankin Scale, mRS\<3
* Intention to treat with aspiration only or combination technique of stent-retriever + aspiration in the first pass attempt during endovascular thrombectomy

Exclusion Criteria:

* Severe stenosis (\>90%), or tandem occlusion of the ipsilateral extracranial internal carotid artery.
* Previously deployed stents in the ipsilateral internal carotid artery.
* Dissections of the ipsilateral internal carotid artery.
* Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
* Subject participating in a study involving an investigational drug or device that would impact this study.
Pre-operative Carbohydrate Drink to Preserve Peri-operative Insulin Sensitivity

Enhanced Recovery after Surgery (ERAS) pathways include multiple evidence-based interventions delivered throughout the peri-operative period that aim to attenuate the surgical stress response and support rapid physiologic and functional recovery.A key element of the ERAS pathway is the administration of a clear carbohydrate-rich beverage 2-3 h before surgery in order to keep the patient in a fed state rather than a fasted state when they go to the operating room. The aim of the current study is to investigate the impact of a drink containing simple carbohydrate on attenuating surgical stress induced insulin resistance in patients undergoing major laparoscopic abdominal surgery, compared to drinks containing maltodextrin.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Planned laparoscopic partial colon resection for non-metastatic neoplastic or benign disease (including right, transverse, left or sigmoid))
3. HbA1c less than or equal to 5.7%
4. Not receiving any kind of glucose lowering medication.

Exclusion Criteria:

1. Are already diagnosed with diabetes or pre diabetes (HbA1c \> 5.7%)
2. Are pre-diabetic receiving glucose lowering intervention (any glucose lowering medication)
3. Have renal or liver dysfunction (serum creatinine above 1.4 mg/dL in women and 1.5 mg/dL in men, bilirubin \>2.9 mg/dL)
4. Will undergo extended resection of adjacent organs
5. Non-elective operations
6. New stoma created
7. Have conditions precluding participation in the ERAS pathway (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)
8. Have conditions requiring preoperative fasting: documented gastroparesis, patient on metoclopramide and/or domperidone, achalasia, dysphagia (any difficulty with swallowing), or Fluid restriction (e.g. dialysis, pulmonary oedema, congestive heart failure).
9. Have cardiac abnormalities, severe end-organ disease such as cardiac failure (New York Heart Association classes III-IV), chronic obstructive pulmonary disease (documented by abnormal pulmonary function test), morbid obesity (BMI \>40 kg/m2), anemia (hematocrit \< 30 %, hemoglobin \<100g/L, albumin \< 25mg/dl)
10. Have received steroids for longer than 30 days
11. Have poor English or French comprehension.
Validation of a New Sexuality Questionnaire for Patients With Urinary Incontinence or Pelvic Organ Prolapse

The main objective of this study is to perform the linguistic validation of a new french questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.


Eligibility Criteria:
Inclusion Criteria:

* The patient is able to read and understand French
* The patient must be insured or beneficiary of a health insurance plan
* Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Exclusion Criteria:

* Patient is pregnant
* The patient is under judicial protection, under tutorship or curatorship
* The patient does not understand French
Oxygen Delivery Methods of Nasal Catheter on the Incidence of Hypoxemia in Patients with Painless Gastroscopy

In this study, patients undergoing painless gastroscopy were selected to change the nasal catheter oxygen delivery mode to oral oxygen delivery after endoscope implantation, in order to explore the effect of this oxygen delivery mode on the incidence of hypoxemia during general anesthesia gastroscopy.

This study was a randomized controlled study in which patients undergoing elective painless gastroscopy were selected and grouped by random number table. The control group used conventional nasal cannula oxygen method: nasal cannula was used before, during and after gastroscopy was implanted and after withdrawing from the gastroscopy. Test group: Before the gastroscope enters the oral cavity, oxygen is administered through a nasal catheter via the nose. After the gastroscope enters the oral cavity, oxygen is administered through the nasal catheter via the mouth. After the gastroscope is withdrawn, oxygen is administered through the nasal catheter via the nose. The incidence of intraoperative hypoxemia was observed.

Eligibility Criteria:
Inclusion Criteria:

Patients who receiving gastroscopy under general anesthesia, accompanied with one of the following risk factors of hypoxia:

1. Patients combined with heart or respiratory diseases
2. Age older than 60
3. ASA grading II-III
4. BMI≥30kg/m²,
5. Snoring or having sleep apnea syndrome
6. Patients with a STOP-Bang score ≥ 3 (the risk of OSAS is high) are considered to be highly risk of hypoxia.

Exclusion Criteria:

1. Severe cardiovascular, pulmonary, liver, or kidney disease
2. Patients with infections or tumors of airway
3. History of difficult intubation under general anesthesia
4. Severe sleep apnea syndrome \[hypopnea/apnea hypopnea index (AHI)\>40\]
5. Patients allergic to propofol, eggs, soy or egg whites
6. Pregnancy
Immune Response of Haemodialysis Patients Post Covid-19 Vaccination

The purpose of this study is to assess immune response of end stage renal failure patients after Covid 19 vaccination


Eligibility Criteria:
Inclusion Criteria:

* ESRF patient on hemodialysis who are eligible for the goverment Covid 19 vaccination programme
* 18 years old and above
* consented to join the study

Exclusion Criteria:

* patient who refused to be vaccinated
* patient who deemed unsuitable for Covid vaccination