cyrilzakka/clinical-trials huggingface dataset:
Research of the Effect of Reservoir Oxygen Mask Application on Respiratory Parameters in Sedated Adult Patients for Gastrointestinal System Endoscopy

With the oxygen mask with reservoir, oxygen can be given to patients with FiO2 values that can reach 80-100%. Reservoir oxygen mask is superior to other oxygen treatment methods with the high oxygen rate applied.Our hypothesis is that the use of an oxygen mask with a reservoir will reduce the incidence of respiratory complications in adult patients who will undergo sedation in the endoscopy unit.

During the sedation procedure in the endoscopy unit, patients who used a reservoir oxygen mask will be examined. Patients over the age of 18 and under the age of 70, with ASA 1-2 risk score, who are planned to be operated under sedation in the endoscopy unit of our hospital will be included. Patients who do not have verbal and written consent to participate in the study, have an ASA3-4 risk score, and are scheduled for emergency procedures will be excluded from the study. No premedication will be applied to patients admitted to the endoscopy unit. As a standard, intravenous vascular access will be established with a 22 gauge intraket on the back of the left hand in all patients, 6-10 lt/minute oxygen therapy will be started with a reservoir mask, and peripheral oxygen saturation, end-tidal CO2, blood pressure arterial values will be monitored and recorded. These parameters will be monitored and recorded every five minutes during the procedure. In addition, the sedative agents applied to the patients and their doses will be recorded. After the procedure, all patients will be taken to the recovery room, where they will be observed until the modified aldrete score is 9 or higher. The recovery times of the patients, nausea, vomiting and similar symptoms will be followed and recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 and under the age of 70
* Patienst with have an ASA1-2 risk score

Exclusion Criteria:

* Patients who do not have verbal and written consent to participate in the study
* Patienst with have an ASA3-4 risk score,
* Patients scheduled for emergency intervention.
Continuous Thetaburst Stimulation for the Treatment of Refractory Epilepsy - Safety, Feasibility and Proof-of-concept

The purpose of this study is to investigate a novel stimulation protocol of repetitive transcranial magnetic stimulation (rTMS) for the treatment of unifocal neocortical epilepsy, namely continuous thetaburst stimulation (cTBS). As this is a pilot study, the primary endpoint is on safety and tolerability of the treatment. However, information on clinical efficacy and mechanism of action will also be collected.

1. Study design:

   This is an open label prospective pilot trial of continuous thetaburst stimulation (cTBS) in patients with unifocal neocortical epilepsy.

   The study comprises a 13-week period, consisting of 4 weeks baseline seizure frequency assessment, a one-week treatment period with baseline assessments on Monday (T0) and stimulation sessions from Tuesday to Friday (T1-T4), and an 8-week follow-up period with short-term assessments immediately after the final stimulation session on Friday afternoon (T4) and long-term assessments after 2 weeks (FU2) and 8 weeks (FU8).
2. Objectives:

   The primary objective is to assess the feasibility, safety and tolerability of cTBS in refractory epilepsy patients. The secondary objectives are to assess the clinical efficacy and associated mechanism of action of cTBS in unifocal neocortical epilepsy.
3. Rationale:

An open label prospective design allows to make a first estimate on the safety, feasibility and tolerability of cTBS in refractory epilepsy patients. There are currently no reports available of cTBS performed in epilepsy patients. The ultimate aim is to assess clinical efficacy of cTBS with regard to seizure frequency, but a feasibility and safety study is a prerequisite in order to achieve this goal.

Eligibility Criteria:
Inclusion Criteria:

* Refractory unifocal neocortical epilepsy with a well-defined ictal onset zone based on a standardized presurgical evaluation
* ≥ 4 seizures/month, for at least six months
* On a stable drug regimen for at least 2 months
* IQ \>70
* Reliable completion of a seizure diary by patient or caretakers
* Therapeutic compliance in the past
* Informed consent signed

Exclusion Criteria:

* Pregnancy, short-term birth wish or childbearing age without adequate birth control
* History of psychogenic non-epileptic seizures
* Intracranial metal hardware (excluding dental filling): surgical clips, shrapnell, electrodes under the stimulation area
* Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants or deep brain stimulation (DBS)

Patients with a vagus nerve stimulator are not excluded, provided that adequate distance between the coil and the implanted material can be maintained.

As the short duration of the study will not interfere with an ongoing presurgical evaluation and/or its eventual conclusion, the patients in the course of the evaluation or awaiting surgery are also eligible for inclusion.
Qualitative Assessment of the Impact of TTNS on QOL and Participation

This study through the use of semi-structured interviews or focus groups will explore the lived experience with Transcutaneous Tibial Nerve Stimulation (TTNS) with Neurogenic Lower Urinary Tract Dysfunction to generate user-defined themes regarding bladder function and catheter-related barriers and the daily impacts on one's life.

Identify NLUTD user-defined themes regarding bladder function and and the daily impacts on one's life Specific Aim: Using iterative, semi-structured interviews or focus groups to explore the lived experience using TTNS neuromodulation to generate user-defined themes regarding bladder function and the daily impacts on one's life.

Eligibility Criteria:
Inclusion:

Participated in TTNS Study for 1 year.
Cardiovascular Epidemiology in Russian Federation

The study addresses epidemiology of cardiovascular risk factors and major cardiovascular diseases in Russian Federation (urban and rural population). 12 regions of 1600 participants in each will be included.

Plasma lipids and fasting glucose, heart rate and blood pressure, anthropometry, smoking and alcohol questionaries, nutrition, sleep quality, stress will be assessed. ECG records are obtained form all participants. Subclinical target organ damage (carotid and periferal atherosclerosis, pulse wave velocity) will be measured in selected sites. Brain natriuretic peptide, adipose tissue cytokines, hsCRP and genetic markers are also under evaluation

Eligibility Criteria:
Inclusion Criteria:

- informed consent

Exclusion Criteria:

No
A Comparative Effect of Echogenic Needle for Nerve Block on Acute and Chronic Postoperative Pain

Surgical pain is a common complication after surgery, affecting patient recovery and treatment quality. \>20% of patients suffer from chronic postoperative pain. China has \>70 million surgeries yearly. Nerve block manages postoperative pain, with developing nerve block needles now used in clinics. Developed needles may have better pain management effects than non-developed ones, but their effect on reducing chronic pain remains unclear. This study aims to explore the effect of developed nerve block needles on postoperative pain and compare them to non-developed needles, providing new ideas and methods for pain management.

Surgical pain is one of the common complications after surgery, which seriously affects the recovery and treatment quality of patients. More than 20% of patients will suffer from postoperative chronic pain. According to the data of the National Bureau of Statistics, there are more than 70 million surgeries in China every year. Nerve block is one of the most commonly used methods for postoperative pain management in clinical practice. In recent years, the developing nerve block needle has gradually begun to be used in clinical practice. Compared with the ordinary non-developing nerve block needle, it may have a better effect on pain management after surgery, but whether it has a reduction effect on chronic pain after surgery is still unknown. The purpose of this study is to explore the effect of developing nerve block needle on postoperative pain, and to compare the difference between it and the common non-developing nerve block needle, so as to provide new ideas and methods for postoperative pain management.

Eligibility Criteria:
Inclusion Criteria:

1. The age is above 18 years old and below 70 years old.
2. patients whose surgical sites were in the chest, abdomen, upper limbs or lower limbs, including lobectomy, cholecystectomy, gastrointestinal resection, hysterectomy and other elective operations.
3. This operation was the first operation during the hospitalization.
4. Consent to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Patients with a history of alcohol or drug addiction.
2. Patients with disturbance of consciousness before operation.
3. Other conditions considered by the attending physician or researcher to be inappropriate for the study;
4. History of chronic pain.
5. Abnormal coagulation function.
Progesterone Levels and Endometrial Compaction in Frozen-Thawed Embryo Transfer Cycles

This study is intended to determine whether there is a correlation between endometrial compaction and serum progesterone levels on the day of frozen embryo transfers by using transvaginal sonography for the endometrial assessment.

This study is planned to be conducted by prospectively evaluating approximately 200 frozen embryo transfers within 6 months in a single center. Patients planned to be included in the study are started estrodiol 6 mg / day on day2-3 of mensturation. 12 days after the start of estrogen, patients who have endometrial thickness over 7 mm are then started vaginal progesterone supplementation as per routine practice and are eventually proceeded to embryo transfer either on day 4 or 6 of progesterone supplementation. In this study investigators are intended to measure endometrial thickness transvaginally on the day of embryo transfer to accurately determine the presence of endometrial compaction, assess serum progesterone levels, evaluate any possible correlations between endometrial compaction, serum progesterone levels and pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

1. Woman aged 20-40 years
2. Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles
3. Having available blastocyst(s) cryopreserved by vitrification method.

Exclusion Criteria:

1. Recurrent implantation failure
2. Recurrent pregnancy loss
3. Presence of uterine pathology
4. Requirement for fresh embryo(s);
5. Presence of any clinically relevant systemic disease contraindicated for assisted reproduction or pregnancy
6. Allergy history for relevant drugs
7. Body mass index of \<18 or \>38 kg/m2 at screening
8. Current breastfeeding or pregnancy
9. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests
10. Natural or modified natural cycles
PrEP Readiness Interventions for Supporting Motivation

The overarching goal of this formative research is to examine whether, and in what combination, contingency management (CM) and motivational interviewing (MI) can facilitate entry of stimulant-using men who have sex with men (MSM) into the pre-exposure prophylaxis (PrEP) care continuum.

In Stage 1, participants will be randomized to receive either: 1) three months of CM; or 2) two sessions of MI. All participants will be assessed at three months post-randomization for non-response. In Stage 2, a second randomization where non-responders (i.e., those who have not filled a PrEP prescription) are assigned to: 1) Switch to sequentially receive the other intervention (i.e., CM+MI or MI+CM); or 2) Continue with assessments only (i.e., CM-Only or MI-Only). All participants will complete a final assessment at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Sexually active cisgender sexual minority man
* Reports using stimulants in the past three months
* HIV-negative serostatus
* Meets Centers for Disease Control and Prevention (CDC) criteria for PrEP eligibility

Exclusion Criteria:

* Currently prescribed PrEP
* Unable to provide informed consent
* Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to participate
Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AD03 Applied During AFF005A

This is a phase Ib follow-up study to evaluate long-term safety and tolerability of immunization with AFFITOPE AD03 applied during AFFiRiS 005A.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed and dated by the patient and the caregiver.
* Patients having participated in AFFiRiS 005A and received ≥1 vaccination with AFFITOPE AD03
* Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits and being available for the telephone phone calls

Exclusion Criteria:

* Patients having received no vaccination with AFFITOPE AD03
* History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
Training Language and Literacy for Children Who Use CIs

This study aims to determine the effectiveness of computer games to improve language and literacy outcomes for children who have hearing loss. Children will be assigned to one of four conditions: phonological awareness training, working memory training, phonological awareness + working memory training, or active control.

Both phonological awareness and working memory are known to be important for children's language and literacy learning. Though there are computer games that claim to improve phonological awareness and working memory, it is unknown if these games will improve language and literacy skills for children who have hearing loss.

The investigators will first determine if the games are effective for improving language and phonological awareness in children with hearing loss relative to an active control condition. Secondly, the investigators will determine if gains in phonological awareness and working memory translate into gains in language and literacy skills relative to active control.

Eligibility Criteria:
Inclusion Criteria:

* Prelingual hearing loss
* Use of amplification device (hearing aid and/or cochlear implant) for at least one year
* Able to visit the clinic 3x/week for 12 weeks

Exclusion Criteria:

* No developmental delays (Down's syndrome, Autism spectrum disorder)
Analgesic Efficacy of Maxigesic in Breast Cancer Surgery

The present study aims to find a perioperative analgesic method that provides sufficient analgesia while reducing immune compromise in cancer surgery. This study is to investigate the analgesic effect and safety of Maxigesic inj. (a combination of acetaminophen 1000 mg and ibuprofen 300 mg), which is added to opioid-based IV-PCA in patients undergoing breast cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 20 to 70 years with ASA classification 1 to 3 undergoing breast cancer surgery (cancer resection or reconstruction)

Exclusion Criteria:

* ASA classification 4/ allergy to acetaminophen, NSAIDs, opioid/ severe liver or renal dysfunction/ pregnancy
Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma

Primary objective:

To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV

Secondary objective:

To evaluate time to progression, 6month survival, overall survival, safety and tolerability of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV


Eligibility Criteria:
Lists of Inclusion and Exclusion criteria:

* Patients must have histologically confirmed hepatocellular carcinoma
* Patients must have measurable disease by CT scan
* Have not received previous palliative systemic chemotherapy for metastatic disease. (Adjuvant chemotherapy or radiation therapy for non target lesion can be allowed.)
* Patients progress after previous local treatment and at the time of randomization is at least 4 weeks after the last interventional therapy (Hepatic Artery Infusion, Trans-Artery Embolization or Trans-Artery Chemo-Embolization) or at least 4 weeks after the last radiotherapy/ablation/ Percutaneous Ethanol Injection to the target lesion.
* WHO 0-2 grades (Karnofsky Performance Score ≥ 70)
* Patients must have adequate organ and marrow function:

  * Neutrophilus ≥ 1.5 x 10\^9/L
  * Platelets ≥ 75 x 10\^9/L
  * Asparagine AminoTransferase, Alanine AminoTransferase \< 2.5 x Upper Normal Limit(UNL)
  * Total Bilirubin ≤ 1.5 x UNL
  * International Normalized Ratio \< 1.5
  * Child stage A or B
  * Creatinine ≤ 1.5 X UNL

Exclusion Criteria:

* Documented allergy to platinum compound or to other study drugs.
* Active Gastro-Intestinal bleeding and active haematologic malignancy
* Previous liver transplantation.
* Patients concomitantly receiving any other anti-cancer therapy.
* Patients who are receiving any other study treatments.
* Pregnant or lactating women or women of childbearing potential without proper contraceptive methods.
* History of other malignant diseases, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
* Central nervous system metastasis
* Other serious illness or medical conditions
* Neuropathy ≥ grade 2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Mindfulness in Hidradenitis Suppurativa

The study will investigate the impact of an 8-week-long Mindfulness-Based Stress Reduction course on quality of life and disease severity in patients with hidradenitis suppurativa (HS).

This is a voluntary 8-week-long, non-medical intervention study for patients with hidradenitis suppurativa (HS). This study will enroll participants in an 8-week-long Mindfulness-Based Stress Reduction course and observed for any changes in validated measures of quality of life. Quality of life scores will be evaluated via multiple surveys including the Dermatology Quality of Life index, HS Quality of Life index, GAD7, and PHQ9. Surveys will be collected Week 1 of 8 week MBSR course intervention; Week 4; End of MBSR Course at week 8; and Week 12. The first goal is to investigate the effectiveness of the addition of mindfulness-based stress reduction (MBSR) intervention to conventional medical treatment on improving mental health in HS participants. The second goal is to assess participant preference for MBSR intervention.

Eligibility Criteria:
Inclusion Criteria:

* This study will only enroll subjects between the ages of 18-years and 89-years of age.
* Diagnosis of HS
* Able to read and comprehend study materials in English, ie: surveys

Exclusion Criteria:

* Those who do not fit inclusion criteria
* Non-English speaking
* Patient who recently began any psychotropic medication within 3 months prior to the baseline evaluation visit.
Observatory: Search for Prognostic Factors of Pulmonary Hypertension Post-capillary in Heart Failure

This study will better understand the post-capillary pulmonary hypertension in heart failure, to determine its prognostic role and to consider specific treatment of different forms of pulmonary hypertension in post-capillary pulmonary heart failure.

Patients with heart failure (HF) frequently have a post-capillary pulmonary hypertension (HTPcap) which has two forms: passive and reactive.

The prognosis, prevalence and pathophysiological mechanisms of cell and tissue involved in the onset and reversibility of these two forms of HTPcap remain poorly understood.

The latest recommendations of the European Society of Cardiology and the European Respiratory Society identify two forms of HTPcap in the IC as a function of the extent of trans-pulmonary gradient (GTP) measured during right heart catheterization (GTP = mPAP-Pcap): passive (GTP £ 12mmHg) and reactive (GTP\> 12mmHg).

In the latter form, the increase in pulmonary pressure would be disproportionate to the increase in left ventricular pressures.

This study will permit to identify hemodynamic prognostic markers of the the IC, and clinical, biological and hemodynamic determinants of the HTPcap in the IC.

This will help to identify a population that could benefit from specific treatment to referred pulmonary artery.

Eligibility Criteria:
Inclusion Criteria:

* Patient with heart failure (LVEF preserved or altered or valvular heart disease) defined by a history of heart failure or LVEF less than or equal to 50%.
* Patient with a right heart catheterization for medical reasons
* Medical treatment considered optimal: beta blockers, ACE inhibitors or angiotensin II receptor antagonists and/or aldosterone
* Stable Patient: No significant cardiac decompensation or change the dose of diuretics for 28 days.
* The patient has agreed and have signed consent.

Exclusion Criteria:

* Patient is younger than 18 years.
* Patient with unstable heart failure (cardiogenic shock, acute cardiac decompensation).
* Coronary heart disease for which there is a maximum revascularization
* Organic valvular which is scheduled for surgical correction of valvular abnormality (plasty or replacement).
* Patient dialysis.
* PAH original pre-capillary catheterization, defined by a Pcap ≤ 15 mmHg.
* Patient with triple installation of PM within 90 days.
* Patients who underwent revascularization within 90 days.
* Patients who underwent mechanical ventricular assistance.
* Patient with severe lung infection (CPT \< 60% of predicted, FEV \< 60% predicted) or pulmonary embolism or respiratory failure with a paO2 in ambient air below 60mmHg or oxygen therapy.
* Patient with severe heart rhythm.
Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Type 2 DM

This study determines the effect of olive oil and bran oil on antioxidant levels, and glycemic control in patients with type 2 diabetes mellitus (DM)

Intervention: Patient type 2 DM will receive olive oil and bran oil with cross over study

Diabetes mellitus (DM) has become one of the global public health problems. The chronic complications of type 2 DM can be macrovascular and microvascular complications that can decrease the quality of life of the patient. The main goal of sustainable DM nutrition therapy is to keep glucose in the blood close to normal levels to stop hyperglycemic and hyperlipidemic events that may inhibit further complications

This study was a clinical trial with cross over study design, random allocation, and double blindness to compare changes in antioxidant, glucose, cholesterol and triglyceride levels supplemented with 15 ml / day of olive oil (KZ) with supplementation of 15 ml / day of bran oil (KB). Provision of oil for 4 weeks in a row. During the 2-week interval not being treated (wash out). After the wash out period cross-over by exchanging olive oil supplementation to rice bran and vice versa for 4 consecutive weeks. The research will be conducted at Family Clinic Clinic FKUI Kayu Putih, Jakarta.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes aged 30-60 years.
* Diagnosed type 2 DM \<3 years.
* Body mass index of 20-30 kg / m2
* Subjects willing to participate in research and sign informed consent.
* Drinking OHO (oral hyperglycemic medication).

Exclusion Criteria:

* There are acute and chronic complications.
* Subject is pregnant.
* Get cholesterol-lowering drugs, steroids and other drugs that affect the metabolism of fat.
* Smoking more than 10 cigarettes / day.
* Eat regular supplements that contain phytosterols or other antioxidants that are known by anamnesis.
* Has a disorder or gastrointestinal disease, thyroid, heart, liver, cancer, stroke and kidney are known with medical record data.