cyrilzakka/clinical-trials huggingface dataset:
Sequence Variations of Genes in the Estrogen Pathway and Perinatal Depression

To elucidate the disease pathway of perinatal depression by identifying genetic variants which could play a role in predisposing to the condition and/or lead to better understanding of the pathogenesis of the condition. This is achieved by investigating for associations between oestrogen receptor genetic variants and perinatal depression.

Perinatal (antenatal and postnatal) depression is a common complication of childbearing, affecting 10 to 20% of mothers. In general, women are exposed to fluctuations in estrogen level during childbearing years, especially during pregnancy and following childbirth. For a subgroup of women with genetic predisposition rendering them more sensitive to such changes, pregnancy or childbirth can act as a trigger for the onset of perinatal depression.

A case control study will be conducted to evaluate the association of variants in estrogen receptor and related genes with the disorder in our population. Women attending antenatal and postnatal clinics will be screened with the Edinburgh Postnatal Depression Scale and cases will be identified. DNA from controls who are well throughout the antenatal and postpartum period and cases meeting DSM IV criteria for depressive disorder will be genotyped for various genetic variants. The distribution of single nucleotide polymorphisms and haplotypes and non-genetic risk factors will be compared between cases and controls and within the case group. The risk factors for postnatal depression in relation to peripartum factors such as demographic, obstetric, anaesthetic and pain outcomes will be investigated.

As perinatal depression is known to contribute to inadequate self-care and poor compliance with prenatal care, early diagnosis and treatment interventions are critical for the health and well-being of both mother and infant. In the short term, identified genetic markers that increase vulnerability to puerperal triggering of depression can be an additional screening tool to identify at-risk expectant mothers for early management during a very critical period for mother, infant, and family. In the long run, it may lead to identification of new pathways or treatment targets for this common but under-studied disorder.

Eligibility Criteria:
Inclusion Criteria:

* Anthropometric profile: age 21-35 years; Chinese race; Chinese ancestry for all 4 grandparents
* Natural conception (not artificially assisted)
* Cases: depressive episode during antenatal period or \< 6 months postnatal at time of recruitment; patients with past diagnosis of depression must have been well for 3 months before pregnancy
* Controls: well during antenatal period or \> 6 months postnatal at time of recruitment; no family history of depression or affective disorders

Exclusion Criteria:

* Other psychiatric disorders (non-mood disorders) namely schizophrenia and substance dependence
* Previously diagnosed neurological disorders
The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit

Pain is an unpleasant sensory and emotional experience resulting from tissue damage. Pain management is typically conducted according to the World Health Organization (WHO) pain management ladder. Analgesics administered to pediatric patients vary in dosage and type, but these analgesics often have significant side effects. The acupuncture technique using press needles is a non-pharmacological pain therapy modality that has been studied for its ability to reduce the use of analgesic drugs, thereby potentially decreasing side effects associated with analgesic use.

The study was conducted using a randomized controlled trial (RCT) design involving 70 pediatric postoperative patients aged 1-18 years who were admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital. Subjects were divided into two groups: a control group and an experimental group. The control group received standard analgesic therapy and sham press needle application (a patch resembling a press needle without a needle), while the experimental group received standard analgesic therapy and press needle application at acupuncture points after the patient had been in the Pediatric Intensive Care Unit for 24 hours. Pain scale monitoring was conducted at 1, 6, 24, 48, and 72 hours using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale for children aged 1-8 years, and the Numeric Rating Scale (NRS) for children over 8 years old.

This study hypothesizes that the acupuncture technique using press needles can reduce the pain scale in pediatric postoperative patients, leading to a decrease in the use of analgesics and a reduction in side effects associated with analgesic use.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric postoperative patients admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital
* Aged between 1 and 18 years
* Patients with a platelet count greater than 20,000/mL
* Patients undergoing elective surgery
* Willingness to participate in the study

Exclusion Criteria:

* Patients with a local infection at the puncture site
* Patients with anatomical abnormalities of the outer ear
* Failure to complete the acupuncture therapy
* Patients with chronic illnesses who have previously received analgesic therapy
To Linguistically and Psychometrically Validate the Hong Kong Chinese Version of the BPH 3-item Questionnaire

This study is to linguistically and psychometrically validate the translated and culturally adapted Hong Kong Chinese version of the BPH 3-item questionnaire.

A new BPH 3-item questionnaire has recently been developed and published, and it may serve as a screening tool for male-LUTS due to symptomatic BPE. The questionnaire consists of only three items. A raw score ranging from 0 to 5 is assigned to each of the items, giving a final total score varying from 0 (no symptom) to 15 (very symptomatic). This questionnaire has been translated and validated into five different European languages and was harmonized cross-culturally for linguistic validation, followed by psychometric accuracy testing.

This new questionnaire may help rationalize more early commencement of therapy aimed at reducing the prostate size for the treatment of male LUTS due to BPE.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 90 years old Chinese male subjects presented with male-LUTS for at least 4 weeks
* The subjects are able to read and fully comprehend with the content of the questionnaires
* The subjects are willing to give informed consent for the study

Exclusion Criteria:

* peak uroflow ≤4mL/sec;
* post-void residual (PVR) ≥300 mL;
* unable to give informed consent
* need of clean intermittent self-catheterization / indwelling urethral catheterization at the time of enrolment;
* Surgical treatment (e.g. TURP) of bladder outlet obstruction / symptomatic benign prostate enlargement (BPE) ≤ 3 months before entry into the study
* clinical suspicion / presence of untreated urethral stricture and/or bladder neck stenosis,
* clinical suspicion / presence of genitourinary cancer including active prostate cancer with ongoing surgical or radiation treatment, or the need of treatment, or bladder cancer, or persistent unexplained hematuria;
* uncontrolled heart failure / diabetes mellitus(DM) / hypertension(HT);
* neuropathic bladder;
* Currently on dialysis or in consideration for dialysis due to end stage renal disease;
* More than 3 urinary tract infections within the last 12 months;
* Unstable dose of diuretic within the past 3 months;
* Has an artificial urinary sphincter;
* Impaired mental status;
* male-LUTS due to urinary tract infections / chronic prostatitis / chronic pelvic pain
Breathing with Amyotrophic Lateral Sclerosis

The study aims to evaluate the effect of mechanical insufflator-exsufflator on the respiratory functions of Amyotrophic Lateral Sclerosis (ALS) patients evaluated via peak expiratory flow on cough (PEFC) measurements. The evolution of their PEFC is monitored to see if the curative management can have a positive impact on the latter.

Amyotrophic Lateral Sclerosis (ALS) is a rare neurodegenerative pathology without curative treatment at present, the outcome is fatal after 3 to 5 years of evolution on average. The disease results in progressive paralysis of the muscles involved in voluntary motricity (progressive and intricate impairment of locomotor, phonation and swallowing capacities as well as ventilatory function). In France, the management of ALS is based on a diversified multidisciplinary follow-up (physiotherapy, speech therapy, occupational therapy, neuropsychology) in the ALS Reference Center in conjunction with the city care networks. It is centered on the evaluation, and the early compensation of the various symptoms, especially the respiratory problems.

Thus, this study aims to evaluate the effect of mechanical insufflator-exsufflator on the respiratory functions of these patients, evaluated via cough peak expiratory flow measurements (CPEF).

The study is conducted in collaboration with the physiotherapists of each patient enrolled, to evaluate the respiratory function by peak expiratory flow on cough (PEFC) after 4 weeks of treatment with Mechanical In-Exsufflator (MIE) (3 weekly sessions for two weeks, then one daily session for 2 weeks) in ALS patients presenting with a poorly effective cough (PEFC between 160 and 255 L/min) and having an indication of punctual MIE.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed ALS categorized as probable or certain according to the revised Awaji-Shima criteria \[27\].
* ALS of spinal, bulbar or respiratory forms
* Peak Flow measure between 160 and 255 L/min (recommendation of MIE in case of congestion, with the possibility of daily sessions)
* Patient who has not benefited from treatment by MIE in the past year (less than 10 sessions in total)
* Patient able to use the MIE and perform the collection, or having a caregiver able to help
* Patient receiving physiotherapist treatment greater than or equal to twice a week

Exclusion Criteria:

* Psychiatric (DSM-5) or cognitive disorders incompatible with participation in the study
* Contraindication to the use of an MIE (pneumothorax for example)
* Insufficient level in French for understanding the study and completing the questionnaires
* Current or past participation in another innovative research or care program relating to respiratory functions
* Emergency situation for which the MIE must be set up within less than a week

Exclusion during the study :

* Appearance of a serious contraindication to the practice of MIE during the study (for example rib fracture during a fall)
* Patient's physiotherapist refusing to do the study
Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety

The purpose of this study is to determine whether internet-based cognitive behavioral therapy (ICBT) is effective in the treatment of children and adolescents with dental anxiety. The investigators hypothesis is that children and adolescents who have been offered ICBT show significant better performance on outcome measures compared with patients in control group.


Eligibility Criteria:
Inclusion Criteria:

* The participant is between 8-15 years of age
* The patient and parents agree to participate in the research project
* A diagnosis of specific phobia (dental anxiety or intraoral needle phobia) can be established by a psychologist according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition. The internet parent version of Development and Well-Being Assessment (Dawba) and Kiddie Sads (phobic disorders supplement) are used.
* The patient and parents have sufficient language skills in Swedish to manage the treatment and questionnaires
* Have regularly access to computer and the internet
* Have the time, the possibility and motivation to work and practice with ICBT 3 hours each week in 12 weeks
* Parents agree to at least book three visits at the dentist during the 12 weeks treatment
* Parents agree to exposure for intraoral injection at the dentist even if the child does not need dental treatment but suffers from injection phobia

Exclusion Criteria:

* Full points on both child and parent versions of the picture guided behavioral approach test. A maximum score of 17 means that both the child and the parent assess that the child can manage the most challenging situations in dentistry
* A score of 31 or less on both children and parent version of CFSS-DS and do not fulfill criteria for intra-oral injection phobia
* Already have or according to DAWBA and/or telephone interview by psychologist likely to fulfill criteria for a neurodevelopmental disorder diagnosis
* Other psychiatric disorders such as severe depression, eating disorder or self harm behavior that need treatment prior to dentistry related specific phobia
* The participant is undergoing or has planned psychiatric/ psychological examination
* The participant has current/planed psychological treatments
* Stressful life experiences during the past 12 months, such as divorce in the family, somatic illness that parent or the psychologist see as an obstacle in the treatment
* Have received cognitive behavioral treatment for dental anxiety or needle phobia during the past three years
Juvenile Essential Arterial Hypertension and Vascular Function

The main goal of this study is to investigate the association of the juvenile essential arterial hypertension with systemic micro- and macrovascular reactivity and cerebral vascular function, and to examine the potential impact of elevated oxidative stress on this associations.


Eligibility Criteria:
Inclusion Criteria:

* healthy normotensive children and children with essential arterial hypertension

Exclusion Criteria:

* secondary arterial hypertension
* other systemic diseases with immunopathology
* neurodegenerative diseasesat
* children that use therapy which has a high impact on vascular or immunological function (immunotherapy, immunosuppressive therapy, sistemic corticosteroid therapy etc..).
A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A)

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with chemotherapy can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:

* About the safety and how well people tolerate sacituzumab tirumotecan alone or with chemotherapy
* How many people have the cancer respond (get smaller or go away) to treatment


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has one of the following cancers:

  * Unresectable or metastatic colorectal cancer
  * Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
  * Advanced and/or unresectable biliary tract cancer (BTC)
* Has received prior therapy for the cancer
* Has recovered from any side effects due to previous cancer treatment

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* History of severe eye disease
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Motivation in Alcohol Treatment Facilities

The purpose of this study is to determine if and to what extend a composite measure of treatment motivation and behavior change motivation predicts alcohol treatment success. It is expected that the composite measure based on the stages of the Transtheoretical Model of Behavior Change is a better predictor for treatment outcome than treatment motivation or behavior change motivation alone. Participants will be recruited from alcohol treatment centers. A baseline interview regarding their motivation, drinking behavior and personal treatment goals will be conducted. At the end of treatment, treatment staff will be asked about treatment involvement of each participant. Two follow-up interviews will be conducted after 6 and 12 months. To identify the impact of behavior change and treatment motivation on change in drinking behavior, data will be pooled with a non-treatment seeking sample. Conclusions can be drawn on what motivation pattern best predicts behavior change for those utilizing formal help and for those remitting without formal help (self-changers).


Eligibility Criteria:
Inclusion Criteria:

* Alcohol dependence
* Alcohol abuse

Exclusion Criteria:

* Persons physically and mentally not capable of participating in study
Effectiveness of a Nutritional Counseling Tool in Reducing the Amount and Frequency of Sugar Intake

The purpose of the study is to assess the effectiveness of nutritional counselling on added sugar consumption, frequency of snacking and caries experiences expressed as Decayed, Missing, and Filled Teeth score (DMFT).

The study involves two visits: the first lasting approximately 30-45 minutes, and the second about 15 minutes that occurs 2 weeks after the first visit.

Procedures and Activities. Subjects will be assigned to either the control or intervention group by the toss of a coin. Subjects will provide information about their personal health history, including age, gender, and race/ethnicity. Subjects will undergo an oral examination to assess dental health through a DMFT score, which measures decayed, missing, and filled teeth. Additionally, the daily added sugar consumption will be calculated using an app called "Sugar Intake calculator." For the control group, no further nutritional advice will be given, while participants in the intervention group will receive additional guidance on sugar consumption using a tool called Stephan's curve. A log will be given to the subjects to track their daily snacking frequency and what type and amount of snack it entailed. After two weeks, subjects will return for a follow-up to evaluate any changes in dental health, sugar consumption, and snacking habits.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are 18 years or older
* Subjects who will comply with study protocol
* Subjects who can read and speak English
* Subjects available during the study period

Exclusion Criteria:

* Subjects under the age of 18
* Subjects have less than 20 teeth
Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache

The aim of the present study is to investigate whether women taking a new combined oral contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle compared to a commonly used contraceptive pill (Microgynon).


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years (inclusive) at visit 1, for smokers up to 35 years (inclusive)
* Otherwise healthy female subjects requesting contraception and currently using a levonorgestrel, gestodene or desogestrel containing oral contraceptive in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average value of \>/= 35 mm for the 3 highest values on a visual analogue scale during cycle days 22-28.
* Normal or clinically insignificant cervical smear not requiring further follow up (or a normal result obtained within the last 6 months before screening)
* Able to tolerate ibuprofen and willing to use only ibuprofen supplied for the study.

Exclusion Criteria:

* Women with any contraindication for oral contraceptive use
Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer

This is a prospective cohort study designed to evaluate the treatment effect as well as predictive and prognostic factors with special emphasis on the clinical utility of ctDNA in plasma in patients with gastroesophageal cancer. Patients with gastroesophageal cancer are included in 5 separate cohorts scheduled for

* Surgical resection + perioperative chemotherapy (cohort 1)
* Neoadjuvant chemoradiotherapy followed by surgical resection (cohort 2)
* Definitive chemoradiotherapy with curative intent (cohort 3)
* Systemic therapy with the intent to prolong survival (cohort 4)
* Palliative treatment without the use of chemotherapy (cohort 5)


Eligibility Criteria:
Inclusion Criteria:

Gastroesophageal cancer Age 18 years or older Able to understand and sign written informed consent

Exclusion Criteria:

Patients not providing informed consent
Anxiety Control by Erythrina Mulungu

This study evaluated the effectiveness of the Erythrina mulungu in controlling anxiety in patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.

: In this research, characterized as a randomized, double-blind, crossover study, 30 healthy volunteered patients (05 men and 25 women) aged 18 or older who received a capsule of 500mg of Mulungu Matusa ® or placebo, orally, one hour before the procedure were selected. The level of anxiety was assessed through questionnaires and physical parameters, such as blood pressure, heart rate and oxygen concentration. Data were collected, tabulated and analyzed by the following statistical tests: chi-square, t-test, ANOVA and Tukey test, Friedman, Fisher's exact test with significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* indication of bilateral extraction of asymptomatic, impacted mandibular third molars

Exclusion Criteria:

* patients under the age of 18
* any general health problem based on the medical history and physical examination
* history of use of any medication within 15 days before the beginning of the research
* history of hypersensitivity to drugs, substances or materials used in this experiment
* pregnancy or lactation
* history of pericoronitis