cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Online Interpersonal Relationships-Based Pyschoeducation in Increasing Sexual Interest and Arousal in Women With Sexual Interest and Arousal Disorder

This study will be conducted to examine the effectiveness of interpersonal relationships-based online psychoeducation developed for women with sexual interest and arousal disorders.

Female sexual interest and arousal disorders are common among sexual dysfunctions. In addition to the physical and mental health of women with sexual interest and arousal disorder, interpersonal relationships are also negatively affected. Based on this relationship, it is predicted that interpersonal relationship-based psychoeducation will be effective in the treatment of sexual interest and arousal disorder.

Interpersonal Relationship Psychotherapy or counseling is a short-term, easy, accessible approach that focuses specifically on interpersonal problems and is based on attachment theory, aiming to reduce depressive symptoms and improve interpersonal functioning.

The number of internet users and the possibilities of access to the internet are increasing significantly all over the world, and online health services via the internet are becoming widespread. Online psychoeducation inevitably takes its place in internet-based applications with technological developments.

In this context, this study will be conducted to increase the sexual interest and arousal levels of women with sexual interest and arousal disorders through online psychoeducation.

Eligibility Criteria:
Inclusion Criteria:

* A person of female biological sex,
* Expressing difficulties in sexual interest and arousal (yes to at least three of the following criteria) (questions related to these criteria will be added to the interview form)
* Decrease/absence in frequency or intensity of sexual activity,
* Decrease/absence of sexual fantasies/erotic thoughts,
* Inability to initiate sexual intercourse with their partner,
* Lack of sexual excitement and pleasure in almost all sexual relationships (about 75%),
* Decreased/absence of sexual interest/arousal to internal or external sexual erotic stimuli (e.g. written, oral, visual),
* Decreased/absence of genital or nongenital sensations in almost all sexual relationships (approximately 75%).
* Low mean scores on the Female Sexual Function Index and Sexual Interest and Desire Inventory-Female scales (mean score on the Female Sexual Function Index below 26.55, mean score on the Sexual Interest and Desire Inventory-Female below 33)
* Have sufficient knowledge about the use of the Internet,
* Women who have had a sexual partner for at least 1 year are among the inclusion criteria for this study.

Exclusion Criteria:

* Becoming pregnant or planning pregnancy during the psychoeducation period,
* Receive treatment for any sexual dysfunction,
* Withdrew from the study at any stage of the study,
* Women who do not attend more than one session of the psychoeducation will not be included in the study (Women who miss the weekly program of the psychoeducation will be allowed a maximum of 2 make-up sessions).
A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes in Chinese Population

A Translational Study to Describe Asthma Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes associated with Differential Outcomes that may Support Future Development of Personalised Treatment Strategies in Chinese Population


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years of age
* acceptable FEV1 (according to ATS and ERS)
* compliance with study procedures All Asthma Cohorts
* physician diagnosed Asthma greater or equal to 3 months prior to screening visit

Exclusion Criteria:

* history of alcohol or drug abuse within the past year
* pregnant at time of an assessment
* has an altered mental status at the time of informed consent
* receipt marketed or investigational biologic(s) within 3 months or 5 half-lives prior to visit 1, whichever is longer
* history or current upper or lower respiratory infection or symptoms within 2 weeks of baseline assessments
* terminal diseases and/or organ failure or participants otherwise considered not appropriate for the study participation
* Receipt LTRAs or 5-lipoxygenase (5-LO) inhibitors (eg zileuton and montelukast) within 1 month or 5 half-lives prior to baseline, whichever is longer.
Early Versus Late Initiation of Feeding in Premature Growth Restricted Newborns With Absent or Reversed End Diastolic Flow On Umbilical Artery Doppler (AREDF)

The purpose of the study is to compare early versus late initiation of enteral feeding in premature growth restricted babies below the gestational age of 35 weeks born to mothers with prenatal absent or reversal of end diastolic flow in the umbilical artery. Normally the blood flow from the mother to the baby brings all the nutrients required for growth and the very vital oxygen required for survival. These deprived babies with poor blood flow adapt to the not so conducive uterine environment by certain adjustments in blood supply to internal organs. This permits the best possible blood flow to brain heart etc., which are the vital organs and whose adequate functioning is required for survival. As a consequence, the gut (intestines) gets poor blood supply and hence its appropriate functioning may be jeopardized. Such 'premature growth restricted' babies are at increased risk of further growth faltering if not fed adequately as also to a condition called 'Necrotising enterocolitis' if fed liberally like other healthy neonates, characterized by abdominal distension, blood in stools and inability to feed for longer durations thereby further affecting growth. In the past such babies (after birth) were not fed for days together which compromised their growth even further. It is not clear whether continuing to withhold feeds for prolonged duration will prevent NEC but lead to growth faltering and initiating feeds early will potentiate NEC with further compromised growth and increased morbidity. There are no randomized trials on feeding strategies in this group of neonates and hence the investigators planned to carry out this study on comparison of early versus delayed initiation of feeding in preterm SGA infants with AREDF.


Eligibility Criteria:
Inclusion Criteria:

1. Preterm neonates below 35 weeks gestation born at the study center(s)
2. Small for gestational age (SGA) ie weight \< 10th centile for gestation
3. Absent or reverse end diastolic flow (AREDF) in umbilical artery

Exclusion Criteria:

1. Babies with major congenital malformations.
2. Babies with severe asphyxia as defined by apgar score \<4 at 5 min of life with cord/within one hour of life pH\< 7.0.
3. Shock requiring pressor support at the time of randomization.
4. Babies born with gastrointestinal surgical conditions precluding enteral feeding.
5. Babies with abdominal distension, bilious or hemorrhagic aspirates or recurrent vomiting at the time of randomization.
6. Refusal to obtain consent.
7. Gestation below 26 weeks.
8. Hydrops fetalis.
Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)

The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.


Eligibility Criteria:
Inclusion Criteria:

* Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent.
* Participants with histologically or cytologically confirmed ES-SCLC.
* For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
* For Part 3, participants must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and PD-(L)1 inhibitor in the first-line setting.
* At least 1 measurable lesion as defined by RECIST 1.1.
* Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver).

Exclusion Criteria:

* Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy.
* Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
* Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol.
* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* Baseline requirement of supplemental oxygen.
APEX: Adiposity Prevention by Exercise in Black Girls

To determine whether a one year afternoon exercise program will reduce adiposity in African American girls, ages 8 to 10.

BACKGROUND:

Obese children who engage in vigorous exercise programs show beneficial effects on total body percent fat (percent BF) and visceral adipose tissue (VAT); however, little is known about how to prevent accretion of total body or visceral adiposity in high risk youths, such as African-American (AA) females.The project has important health implications for two reasons, as follows. There is a dearth of information concerning the effects of exercise interventions in school and community settings. If the study shows that an afternoon exercise program reduces accretion of general and visceral adiposity and has a favorable impact on fitness and health in a population that is at high risk of obesity, then schools may be encouraged to implement similar interventions to prevent juvenile obesity and associated health problems.

The study was awarded in response to a Program Announcement on Physical Activity and Cardiopulmonary Health released in October 1994 jointly by the NHLBI, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Nursing Research.

DESIGN NARRATIVE:

The design involves randomization of 200 African American girls, eight to 10 years of age into intervention or control groups. After one year, the groups are compared to test the primary hypothesis that a one year afternoon exercise program will reduce accretion of general and visceral adiposity in these girls. Then the girls will switch group assignments for the next year. The pattern of data over the three time points will show what happens over a two year period in which the youths are, or are not, involved in the exercise program. The measurements will include: (1) percent body fat with dual-energy x-ray absorptiometry; (2) visceral adipose tissue (VAT) with magnetic resonance imaging; (3) cardiovascular fitness with a multi-stage treadmill test; (4) cardiovascular disease (CVD) risk factors (i.e., the ratio of total to high density lipoprotein cholesterol, insulin, systolic blood pressure, and fibrinogen); (5) free-living exercise and diet; (6) psychosocial variables (i.e., self-efficacy and self-concept); (7) sexual maturation; (8) anthropometric measures. The exercise program will be implemented in neighborhood schools for 90 minutes each weekday afternoon. Transportation will be provided if needed. Sessions will include motor skill instruction and aerobic exercises.

Eligibility Criteria:
No eligibility criteria
Neuropathic Pain in Patients With Cancer

The purpose of this study is to collect beginning information on whether intravenous (IV) administration of KRN5500 is safe and effective for treatment of neuropathic pain in patients with cancer.

Neuropathic pain is a type of pain that results from nerve damage and is characterized by an abnormal hypersensitivity to harmless as well as harmful stimuli. This type of pain is extremely difficult to manage, fails to respond to standard analgesic medications or interventions, and often gets worse instead of better over time. Current approved therapeutic agents often have intolerable side effects and limited efficacy. Thus, there is an urgent need to develop safe and effective drugs to treat neuropathic pain.

Study DTCL100 will be conducted at multiple centers and will enroll patients that have advanced cancer AND neuropathic pain that has not responded well to previous treatment. Eighteen patients will be randomly assigned to receive up to 8 doses of active drug (KRN5500) or placebo. A maximum of 8 doses will be administered weekly over a 10 week period. Patients are encouraged to complete at least 4 treatment visits before a decision is made to complete the full 10 weeks of treatment and the 1 month followup period.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosis of advanced or recurrent cancer
* No options for curative chemotherapy, but palliative chemotherapy allowed under certain conditions
* Refractory neuropathic pain rated 4 or greater on 0-10 scale and failure to respond to 2 commonly used treatments
* If taking opioids for pain, stable regimen over past week before enrolling
* Karnofsky performance status of 40 or more
* Females must be sterile or post-menopausal

Exclusion Criteria:

* Radiation to site of neuropathic pain for past 4 weeks
* Major surgery within past 2 weeks
* Liver function and other key labs outside normal parameters
* ECG showing significant abnormality
* Myocardial Infarction (heart attack) within past 6 months
* History of interstitial lung disease
* History of severe allergic reaction to drugs containing polysorbate 80
* Other investigational drug within 2 weeks or 5 half-lives (whichever is longer
Parent Skills Training for Families of Children With Autism Spectrum Disorder

The study is focused on helping parents master the basic intervention skills and evaluate the effectiveness of this parental training style for children with autism spectrum disorder in China.

The investigators designed a set of parental training curriculum about early intervention.

The curriculum consists of three units: (1) Delivery of theoretical intervention knowledge and analysis of successful training cases; (2) Commenting and making suggestion on parent-child interaction videos; (3) Demonstration of intervention skills and practice .The contents of the curriculum involved setting up an environment, developing objectives (verbal communication, non-verbal communication, social interaction, imitation, fine motor skills, etc.), designing activities, dealing with challenging behavior. This study will help parents master the basic intervention skills(how to set up an environment, develop objectives, design activities, deal with challenging behavior, etc) . At last the investigators will evaluate the effectiveness of this parental training style for children with autism spectrum disorder in China.

Eligibility Criteria:
Inclusion Criteria:

* Children with ASD or high risk for autism;
* Han ethic;
* Parents were at least middle school educated, and agreed to do at least 20 hours per week of planned practice activities with the child in daily life.

Exclusion Criteria:

* Children with Syndromic ASD caused by known genetic defects or inherited metabolic diseases , such as Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis;
* Visual, auditory and physical disabilities;
* Complication with other serious chronic diseases, such as liver and kidney failure, connective tissue diseases, tumors.
Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in Lung Adenocarcinoma

The single arm clinical study is to evaluate the efficacy and safety of Tislelizumab combined with Bevacizumab and albumin paclitaxel in the treatment of advanced lung adenocarcinoma. All of the patients were received EGFR-TKI therapy for 1 line and disease progression. The primary endpoint is six months PFS and safety, the seconday endpoint is ORR and one-year OS rate.

Patients who meet the inclusion criteria will receive Tislelizumab combined with Bevacizumab and albumin paclitaxel for 4 cycles. If there is no disease progression, the patient will continue to receive Tislelizumab maintenance therapy, until the disease progresses or death.

Eligibility Criteria:
Inclusion Criteria:

* lung adenocarcinoma stage Ⅳ(according AJCC 8)
* received EGFR-TKI for 1 line and disease progression
* EGFR T790M negative
* ECOG PS 0-2

Exclusion Criteria:

* histology of mixed NSCLC with squamous cell carcinoma, neuroendocrine carcinoma and small cell carcinoma.
* have received checkpoint inhibitor.
* uncontrolled pleural effusion, pericardial effusion, or ascites after appropriate intervention
* any unstable systemic disease
* patients who were treated with systemic glucocorticoids (\>10mg/ day prednisone therapeutic dose) or other immunosuppressive drugs within 14 days prior to the initial administration or during the study period
A Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

This is a multicenter, single-arm, open-label, Phase 1 study to assess the tolerability, safety, pharmacokinetics, and preliminary anti-tumor activity of tazemetostat in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).


Eligibility Criteria:
Inclusion Criteria:

* Participants with histological diagnosis of B-cell non-Hodgkin's lymphoma
* Participant who has measurable disease
* Participant who had previous therapy with systemic chemotherapy and/or antibody therapy
* Participant who had progressive disease (PD) or did not have a response (complete response \[CR\] or partial response \[PR\]) in previous systemic therapy, or relapsed or progressed after previous systemic therapy
* Participant with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Participant with life expectancy of ≥3 months from starting study drug administration
* Participant with adequate renal, bone marrow, and liver function
* Participant with left ventricular ejection fraction (LVEF) \> 50%
* Male and female participant ≥20 years of age at the time of informed consent
* Participant who has provided written consent to participate in the study

Exclusion Criteria:

* Participant with prior exposure to EZH2 inhibitor
* Participant with a history or a presence of central nerves invasion
* Participant with allogeneic stem cell transplantation
* Participant with medical need for the continued use of potent or moderate inhibitors of CYP3A or P-gp, or potent or moderate inducer of CYP3A (including St. John's wort).
* Participant with significant cardiovascular impairment
* Participant with prolongation of corrected QT interval using Fridericia's formula (QTcF) to \> 480 milliseconds (msec)
* Participant with venous thrombosis or pulmonary embolism within the last 3 months before starting study drug
* Participant with complications of hepatic cirrhosis, interstitial pneumonia, or pulmonary fibrosis
* Participant with active infection requiring systemic therapy
* Women of childbearing potential or man of impregnate potential who don't agree to use a medically effective method for contraception for periods from before informed consent to during the clinical study and 30 days later from last administration of study drug
* Woman who are pregnant or breastfeeding
* Participant who were deemed as inappropriate to participate in the study by the investigator or sub-investigator
Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy

This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of Cow's Milk Protein Allergy (CMPA).

The main purpose of this study is to demonstrate that the rice protein hydrolysed based formula manufactured by Ordesa ensures proper growth and as secondary outcomes, that the formula is devoid of any risk of arsenic or other potential contaminants toxicity and its effect on the duration of CMA (Cow Milk Allergy) from cow's milk protein allergy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects up to 10 months old with clinical history of a reaction to cow's milk protein and/or confirmed diagnosis (up to grade II anaphylaxis) of allergy to cow's milk protein by one of the following criteria, within two months prior to the baseline visit are eligible to enter the study:

  * Negative or positive skin prick tests ( fresh milk, rice, casein hydrolysates)
  * Negative or positive specific IgE for cow's milk proteins (alphalactalbumine, betalactoglobuline, caseine and cow's milk)
  * Negative or positive Milk Atopy Patch Test
  * Positive Double Blind Placebo Control Food Challenge (DBPCFC) with cow milk
* Gestational Age 37-42 weeks inclusive
* Apgar SCORE \>7 at 5 minutes
* Singleton birth
* Birth weight ≥2.500 g
* Written informed consent

Exclusion Criteria:

* Previous signs of allergy to any extensively hydrolysed formula
* Confirmed history of acute severe, potentially life threatening reaction after isolated accidental ingestion of cow's milk e.g. history of anaphylactic reaction, graded more or equal to grade III, as this could not be compatible with an allocation to the eHF group
* Daily formula intake \< 100 ml
* Major congenital malformations or neonatal diseases
* Severe concurrent or chronic diseases
* Intrauterine growth retardation
* Neonatal infections ( e.g. CMV, HIV)
* Simultaneous participation in other clinical trials
* Parents not signing written informed consent
* Unable to adhere to protocol requirements or study visits due to non compliance of parents or caregivers.
* Liver, kidney, haematological abnormalities as judged clinically by investigators at baseline.
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates

The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent from a legally authorized representative
* Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)
* Successful implementation of controlled nCPAP within 90 minutes after birth
* Spontaneous breathing
* Chest radiograph consistent with RDS
* Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth

Exclusion Criteria:

* Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth
* Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface
* A 5 minute Apgar score \< 5
* Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth
* Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH)
* Known or suspected chromosomal abnormality or syndrome
* Prolong rupture of membranes (PROM) \> 2 weeks
* Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
* Need for endotracheal intubation and mechanical ventilation
* Has been administered: another investigational agent or exposure to an investigational medical device, any other surfactant agent, steroid treatment after birth