cyrilzakka/clinical-trials huggingface dataset:
Music vs Relaxation Training in Craving Reduction in Alcohol Dependence Syndrome

The aim of the study was to compare the effectiveness of Music and Progressive Muscle Relaxation as interventions to reduce craving, increase coping, and understand the subjective experience of the interventions with patients diagnosed with Mental and Behavioral Disorders due to Alcohol, Dependence Syndrome, over a 5 day period.

Craving for alcohol produces an aversive, uncomfortable state, with autonomic arousal similar to that in anxiety disorders, and is the main factor leading to relapse. Music has been shown to reduce anxiety and stress levels. Progressive Muscle Relaxation (PMR) is the intervention of choice for treatment of anxiety and related syndromes. This study aimed to compare efficacy of PMR and music in reducing levels of alcohol craving and increasing perceived ability to cope with the craving. The intervention was conducted over 5 days with two randomised group of 10 patients each. The patients were assigned to either group based on randomizer sequencing. Initial motivation was assessed before beginning the study. Measures of craving level and coping were collected on Day 1, 3 and 5. Single question exit interview was conducted to understand subjective perception of the patients regarding the techniques. Significant difference was found in coping levels through use of PMR (p = 0.01), and subjective reduction in craving levels was reported by patients in the music group, though this was not statistically significant. Thus, PMR may be used as an adjunct to increase coping abilities in patients with alcohol dependence, while music may be a useful tool to reduce craving but cannot be conclusively commented upon without further research.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Mental and Behavioral Disorders due to Use of Alcohol, Dependence Syndrome
* Abstinent for at least 1 week

Exclusion Criteria:

* Any other known psychiatric/physical condition
* Risk of Suicide or Relapse
* Less than 75% compliance
The Comparison of Postoperative Pain After Lumbar Fusion Surgery in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment

The postoperative pain of lumbar fusion surgery is very severe that it is necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The most common pain control method of this surgery is the intravenous (IV) PCA. but, if it is relatively insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce the pain intensity effectively. Consequently, it may result in the a lot of rescue analgesics requirement, which leads to the adverse effects in patients who are very sensitive to narcotic analgesics. In addition, the patient's satisfaction to the PCA may be low compared with that of expected. For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a new mode, so that the administered rate and amount of drug can be increased or decreased according to the patient's use of bolus button. Therefore, this PCA device can be implemented to the conventional mode, and added the function of automatically controlling the basal rate and administered amount of drug according to the use demand of the patient. However, since there are few studies related to this new mode of PCA, more research is needed in patients with postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects who undergoing lumbar fusion surgery
2. ASA class Ⅰ-Ⅲ
3. Written consents obtained to participate voluntarily in this clinical trial

Exclusion Criteria:

1. Sudden change of surgical plan
2. Patients who have the hypersensitivity to the pain killers including narcotics
3. Patients who are unable to express the degree of pain
Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Moderate to Severe Glabellar Lines

This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with moderate to severe glabellar lines.

Subjects are randomly assigned into the two groups at the ratio of 2:1. The purpose of study is to confirm the non-inferiority of Neuronox to Botox in terms of the efficacy and safety in subjects with moderate to severe glabellar lines.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 and 65
* Subjects with more than grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum frown

Exclusion Criteria:

* Subjects with medical conditions who may be greater risk due to the administration of the investigational drugs
* Subjects with skin disorders at the injection site
Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

This multicenter prospective clinical trial investigates the accuracy of ultrasound to predict relapse after discontinuation of infliximab and the efficacy/safety of readministration of infliximab in patients with rheumatoid arthritis in a low disease activity state.

The objective of this multicenter prospective clinical trial is to determine whether ultrasound predicts relapse after discontinuation of infliximab more accurately than does clinical index and to investigate the efficacy and safety of restarting infliximab after relapse in patients with rheumatoid arthritis in remission or low disease activity on infliximab treatment. Infliximab is discontinued in all enrolled patients. Patients are followed up for 48 weeks for monitoring relapse. If relapse occurs, patients receive readministration of infliximab and are further followed up for 24 weeks to determine the efficacy and safety of infliximab readministration. Primary endpoint is the difference in area under curve (AUC) of receiver operator characteristics (ROC) analysis between total power Doppler score and Disease Activity Score (DAS) 28 at baseline to predict relapse within 48 weeks after discontinuation of infliximab.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. RA patients who fulfill 2010 ACR/EULAR Classification Criteria
3. Patients who have been treated with infliximab (Remicade) for 26 weeks or longer
4. DAS28 (CRP) \< 3.2 at screening
5. Patients who give written informed consent after receiving sufficient information -

Exclusion Criteria:

1. Receiving prednisolone \> 10 mg/day
2. Receiving biological or molecular-target anti-rheumatic drug
3. Alteration of the dose of corticosteroid or anti-rheumatic drug within 8 weeks prior to screening visit
4. Alteration of the dose of non-steroid anti-inflammatory drug within 4 weeks prior to screening visit
5. History of infusion reaction to infliximab
6. Current infection which requires treatment
7. Current or previous demyelinating disorder
8. Current congestive heart failure which requires treatment
9. Breast-feeding or pregnant/possibly pregnant woman, or woman who does not agree to prevent conception during and 6 months after study period
10. Patients whom investigator or co-investigator consider inappropriate for other reasons -
FemPulse Therapy for Overactive Bladder in Women

The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Eligibility Criteria:
Inclusion Criteria:

* Females 21 years or older with a diagnosis of Overactive Bladder
* If of reproductive age, must use a reliable form of contraception

Exclusion Criteria:

* Pregnant, was recently pregnant or is trying to conceive
* Has a metal pelvic implant or any electrically active implanted medical device
* Had a previous hysterectomy, pelvic radiation or pelvic cancer
* Has significant pelvic organ prolapse
* Had bladder treatment with onabotulinumtoxinA in the previous 12 months
* Has a significant heart condition
Estimating the Global Need for Palliative Care for Children

A cross-sectional analysis of prevalence data from a stratified sample of 23 countries used to estimate the global need for palliative care for children aged 0-19 years. Prevalence data, from the Institute for Health Metrics and Evaluation, was for 12 major diagnostic groups needing children's palliative care according to WHO and UNICEF guidelines.

There is growing awareness that there are major gaps in access to children's palliative care (CPC) worldwide. Adults have a greater likelihood of receiving palliative care than children. Growing access to treatment services, and extended periods of wellness have led to some changes in the nature of the palliative care services required. Children are more resilient and more likely to require CPC for longer periods than adults.

It is against this background that UNICEF and the International Children's Palliative Care Network (ICPCN), in collaboration with national palliative care associations, began a joint analysis to develop methods to assess critical needs and gaps in CPC. The initial assessment, conducted in Kenya, South Africa and Zimbabwe, aimed to analyse existing secondary data on palliative care to estimate the palliative care need amongst children and explore key gaps in the response with service providers. A report on this research, the methods used, and the results for South Africa was published in 2014.

There is a lack of information regarding the actual need for palliative care for children, and assessment is a complicated process, due to uncertainty about the patient population and the nature of palliative care for children. Although there have been some studies focusing on the status of CPC in sub-Saharan Africa and the United Kingdom, there are differences in the scope and approach to the present study. A systematic review of the provision of CPC around the world, noted that over 65% of countries have no recognised CPC service provision, and concluded that service provision for CPC is not meeting the need in the majority of the world.

Generally, studies estimating need for palliative care for children are based on mortality statistics for chronic, incurable illnesses. Estimates focused on end-of-life care, as in the Global Atlas of Palliative Care at the End of Life do not account for the children that need palliative care well before the last year of life and underestimate the need.

The World Health Organization defines palliative care for children as a special, albeit closely related field to adult palliative care. An effort to define the many diseases and conditions requiring CPC a directory was published in 2013 with 376 potential diagnostic labels though the majority of deaths were from a small number.

Eligibility Criteria:
Inclusion Criteria:

* have one of the conditions above

Exclusion Criteria:

* greater than 19 years of age
A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces

The purpose of this study is to learn about- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines:

* abiraterone,
* apalutamide,
* enzalutamide.

Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Most prostate cancers need male hormones to grow. When cancer cells respond to treatment that lowers male hormones, this is known as castration-sensitive prostate cancer.

This is a real-world study, not a clinical trial. This means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use information from National Veteran's Affairs (VA) Health Care Network.

The study will include patients' information from the database for men who:

* were identified to have mCSPC.
* started treatment with NHT for mCSPC.
* were 18 years of age or older at start of NHT.

Men in this study will be taking NHT for treatment of their mCSPC. The study will explain:

* how long men take the therapy.
* how long it takes to start next therapy.

This study will use patient information about medications and treatments from VA data. This study will use information one year before start of NHT until information is available.


Eligibility Criteria:
Inclusion Criteria:

* Male with ≥ 1 diagnosis claim for prostate cancer
* Had documented secondary metastasis code on or after the initial prostate cancer diagnosis
* Had initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 90 days prior to the metastasis date or on or after the metastasis date. The initiation date of the earliest novel hormonal therapy will be defined as the index date
* ≥18 years old on index date
* Continuous enrollment for at least 365 days before index date
* Evidence to be castration-sensitive:

  * No prior surgical castration any time prior to the index date or no medical castration with ≥8 weeks of continuous use within -90 to -365 days prior to the index date, OR
  * Diagnosis of hormone sensitive malignancy status within 90 days before the index date

Exclusion Criteria:

* Evidence of castration-resistance prior to the index date

  * Received other prostate cancer treatment including NHT, non-steroidal anti-androgen (NSAA), chemotherapy, immunotherapy, radium 223, lutetium Lu 177 vipivotide tetraxetan, ketoconazole, or PARP inhibitor prior to the index date
  * Had diagnosis code indicating hormone resistance prior to the index date
  * A rise in prostate-specific antigen from the nadir by ≥2 ng/mL after castration
* Had a prior history of other cancers (except non-melanoma skin cancer)
* Participation in a clinical trial during the 30 days before the index date
IS Three d Power Doppler of the Endometrial and Subendometrial Regions Effective in Predicting Endometrial Implantation?

Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day (progest, micronized progesterone 100mg, Technopharma, Egypt, for pharco pharmaceuticals, Amriya- Alexandria). Five days following ovum pick up, the embryos were transferred at the blastocyst stage.

All women underwent long agonist protocol for controlled ovarian hyperstimulation described by Chang et al. (14) The GnRH agonist was started in the previous mid-luteal phase (decapeptylR R 0.1mg, Triptorelin-Acetate, Ferring GmbH, Wittland 11, D-24109, and Kiel, Germany). After the confirmation of pituitary down regulation (serum LH less than 5 m IU/ml and serum E2 less than 50 pg /ml), the HMG ampoules were started by 225 IU/day (Gonapure 75 IU, IBSA Institute Biochimique SA, Switzerland). During the follow up of overstimulation, the doses were adjusted according to the response of patient. All women underwent serial TVS until at least three dominant follicles were reached in every woman. When the dominant follicles reached 18-20 mm, HCG 10000 (Choriomon 5000 IU, IBSA Institute Biochimique SA, Switzerland) was administered. Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration. The luteal phase was supported by progesterone 300 mg per day (progest, micronized progesterone 100mg, Technopharma, Egypt, for pharco pharmaceuticals, Amriya- Alexandria). Five days following ovum pick up, the embryos were transferred at the blastocyst stage. Twelve days later to embryo transfer, serum pregnancy test was done and if positive (chemical pregnancy), the clinical pregnancy was confirmed by TVS for detection of gestational sacs and embryo cardiac activity. The ongoing pregnancy was detected by abdominal ultrasound at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

a

* age; 22-35 years,
* BMI; less than 35 kg/m2,
* Husband with oligo- or oligoasthenospermia.

Exclusion Criteria:

* \\1-gross uterine and tubal pathology,
* 2-Development of OHSS,
* 3-poor responders,
* 4-failure of oocyte fertilization or failure of the embryos to reach the blastocyst stage and
* 5-Refusal to participate in the study at any step of the ICSI cycle.
Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty

The purpose of this study is to compare the clinical and radiological outcomes of mobile-bearing with that of fixed-bearing in total knee arthroplasty.

Double blind, randomized prospective study Mobile or fixed bearing of the same company

* Mobile bearing group : group M
* Fixed bearing group : group F

Inclusion criteria

* patients expected primary total knee arthroplasty without severe deformity

Clinical outcomes

* Range of motion
* Complication
* Scorings

  * KSS, KSFS, HSS score, WOMAC score, Oxford score, SF-36

Radiological outcomes

* Alignment angles in knee
* Positions of femoral and tibial components
* Position of patella
* Radiolucency

Eligibility Criteria:
Inclusion Criteria:

* primary total knee arthroplasty

Exclusion Criteria:

* infection
* severe deformity in knee
* revision
Expanded Access Protocol for Cemiplimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

The objective of this program is to provide access to cemiplimab (REGN2810) to patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not candidates for surgery prior to cemiplimab (REGN2810) being commercially available.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed diagnosis of invasive Cutaneous Squamous Cell Carcinoma (CSCC)
2. Hepatic function:

   1. Total bilirubin ≤1.5 x upper limit of normal (ULN; if liver metastases ≤3 x ULN).
   2. Transaminases ≤3 x ULN (or ≤5.0 x ULN, if liver metastases)
   3. Alkaline phosphatase ≤2.5 x ULN (or ≤5.0 x ULN, if liver or bone metastases) Patients with hepatic metastases: If transaminase levels (AST and/or ALT) are \>3 x but ≤5 x ULN, total bilirubin must be ≤1.5 x ULN. If total bilirubin is \>1.5 x but ≤3 x ULN, both transaminases (AST and ALT) must be ≤3 x ULN
3. Renal function: serum creatinine ≤1.5 x ULN or estimated creatinine clearance (CrCl) \>30 mL/min
4. Bone marrow function:

   1. Hemoglobin ≥9.0 g/dL
   2. Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
   3. Platelet count ≥75 x 10\^9/L
5. Patients not candidates for surgery include the examples below, but are not limited to:

   * Metastatic disease (distant or nodal)
   * Recurrence in the same location and curative resection is unlikely
   * Significant local invasion that precludes complete resection
   * Surgery may result in severe disfiguration or dysfunction
   * Other conditions deemed to be contraindicating for surgery

Key Exclusion Criteria:

1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment
2. Prior treatment with other immune modulating agents that was (a) within fewer than 4 weeks (28 days) prior to the first dose of cemiplimab (REGN2810), or (b) associated with immune-mediated adverse events (AEs) that were ≥ Grade 1 within 90 days prior to the first dose of cemiplimab (REGN2810), or (c) associated with toxicity that resulted in discontinuation of the immune-modulating agent
3. Continuous immunosuppressive corticosteroid treatment (doses \>10 mg prednisone daily or equivalent) within 2 weeks prior to the first dose of cemiplimab (REGN2810)Note: Patients who require brief course of steroids (eg, as prophylaxis for imaging studies) are not excluded
4. Active uncontrolled infection requiring therapy, including infection with human immunodeficiency virus, or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
5. History of pneumonitis within the last 5 years

Note: Other protocol defined Inclusion/Exclusion criteria may apply
A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated NSCLC

There are limited in depth studies on the epidemiology and clinical management of EGFR exon 20 insertion mutated NSCLC in Asia. In addition, there is preliminary data suggesting the exact location of the insertion and variant may influence the response and efficacy to novel EGFR targeted therapies.

This study aims to fill this knowledge gap, by comprehensively characterising the epidemiology and clinical outcomes of Asian advanced EGFR exon 20 insertion mutated NSCLC patients.

This study will be a multi-center observational study and will enroll patients with advanced EGFR exon 20 insertion mutated NSCLC.

The study will include patients recruited from countries across Asia, including sites in, but not limited to - Hong Kong, Korea, Singapore, Taiwan and Thailand. There will be approximately 20-30 sites recruiting for the study. In Singapore, sites may include National Cancer Centre Singapore (NCCS), National University Hospital (NUH) and Tan Tock Seng Hospital (TTSH).

Approximately 600 patients will be enrolled retrospectively.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed advanced NSCLC
2. Positive testing result from any locally approved test (including but not limited to RT-PCR, Cobas and NGS) for EGFR exon 20 insertion mutation
3. Diagnosis date from 1 Jan 2013 to 31 Dec 2022 (to allow for minimum 12 months of follow-up clinical and treatment outcome data)
4. Male or female adults, age as defined by local regulations

Exclusion Criteria:

1. Patients without an EGFR exon 20 insertion mutation