cyrilzakka/clinical-trials huggingface dataset:
Evaluation of The Effectiveness of The SAFE Early Intervention Program

In this study, it was aimed to examine the effect of SAFE, which is a sensory-based, activity-oriented early intervention approach applied in an enriched environment with family cooperation, on cognitive, language, motor and sensory development in 3-6 months old risky infants. 46 infants with neurodevelopmental risk, whose corrected age was 3 months, were included in the study. Infants were randomly divided into two groups. Infants in the treatment group were included in an early intervention program according to the SAFE approach. Infants in the control group were included in the family education program based on the principles of Neurodevelopmental Therapy (NDT). The intervention was performed for 12 weeks, and all infants were evaluated with Bayley Developmental Scale for Infants and Young Children III (Bayley III) by a blinded investigator before treatment (3rd months) after treatment (6th months) and 12th months.


Eligibility Criteria:
Inclusion Criteria:• Corrected age of 3 months

* Any neurodevelopmental risk (perinatal stroke, perinatal asphyxia, HIE, GMK-IVK, PVL or gestational age of 32 and below)

Exclusion Criteria: • Having a congenital anomaly

* Having a genetic syndrome diagnosis (e.g. Down Syndrome)
* Parents do not speak Turkish
Therapeutic Exercise in Cancer-Related Fatigue in Women After Breast Cancer Treatment

The main objective of this study is to determine whether the proposed program of therapeutic exercise is effective in improving fatigue, more than the exercise unsupervised depending on their preferences, in women treated for breast cancer.

Introduction: The prevalence of cancer-related fatigue in women treated for breast cancer is about 30% having significant effects in reducing their quality of life. There is evidence of the presence of sleep problems and immune response. Several studies claim that physical exercise is effective during and after treatment of the disease as it improves the quality of life, cardiorespiratory function, physical functioning and symptoms of fatigue although not always found significant differences between intervention groups exercises compared with a control group. Although the results of these studies are promising, generally present methodological biases as small sample size, absence of masking, heterogeneous groups, lack of monitoring short and long term and especially lack of specificity in relation to prescribed exercise ( frequency, intensity, time and type of exercise).

Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to two groups:

An experimental group, where the participants will be treated with Therapeutic Exercise;

And a group where will be done Physical Exercise according their preferences.

Pre-intervention, immediate post-intervention, 3 and 6 months assessments will be made. The selection criteria will be: Adult women treated for breast cancer, completed at least 6 months before, with persistent fatigue. All participants must understand and sign freely Informed Consent.

Sample size: 40 women for each group.

Data Analysis: A descriptive analysis of all variables was performed. It establish for all cases a confidence level of 95% (p \<0.05). The effectiveness was assessed by comparing the experienced change of the two groups in outcome variables between physical therapy examinations.

Eligibility Criteria:
Inclusion Criteria:

* Women treated for breast cancer, completed at least 6 months before, with persistent fatigue.
* Women who do not present contraindications for physiotherapy and physical exercise (infection, metastasis, loco regional recurrence, cardiopulmonary disorders).
* Women who have read, understood and signed informed consent freely.

Exclusion Criteria:

* Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.
Strength Training With Eccentric Arm-cranking

The new training device, the eccentric arm-crank, will be examined for its training effect by this project. That the training device can be used in athletes and patients with paraplegia in the future, the so-called "testing of the applicability of this concept" will be carried out during this study. Fourteen volunteer, healthy and trained people are first tested for their upper body performance, followed by a training phase over 20 trainings and at the and the performance data is collected again. The training intensity and duration is continuously increased during the training phase.

At the beginning, the study design includes an familiarisation appointment with performance tests and training on the eccentric arm-crank device (KREHA). At least one week later, the first test sequence including a maximum strength test (bench press), magnetic resonance imaging (MRI) to determine the muscle cross-section area of the upper arm and a test to determine the anaerobic performance (Wingate test) is conducted. The second test sequence takes place one to three days later. This includes a handgrip strength test, an aerobic endurance test (ramp test on the arm crank ergometer with ergospirometry) and a further familiarisation training on the KREHA. The training phase starts within two weeks after the pre-tests have been completed. There are two to a maximum of three trainings per week. These take 30 to 60 minutes and take place on the KREHA device under the supervision of the study staff. The training phase lasts a maximum of twelve weeks (20 training sessions). The first test sequence is repeated five to eight days after the last workout. The second test sequence takes place at the same time interval as in the pre-tests.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* age between 18 and 50 years
* experience in strength training
* trained (minimum two times a week)
* healthy
* adequately informed and confirmed per signature

Exclusion Criteria:

* findings during anamnesis of study doctor
* pregnancy
Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners

The purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.

Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to the earlier placement of the PLwD in nursing homes and increases the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Given the potential harmful side effects of medications, non-medication alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to improve disturbed sleep in this population. CBTi which includes stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has durable and sustained effects on sleep outcomes over the long term. CBTi has improved sleep disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both persons.

There is no current published research on CBTi when the PLwD and their caregivers receive the intervention at the same time; as a result, the research team aims to examine the 1) feasibility and 2) preliminary efficacy of 6-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. PLwD-caregiver dyads will participate in videoconferencing sessions. In addition, semi-structured interviews will take place to examine the acceptability and satisfaction with the intervention.

Eligibility Criteria:
Inclusion Criteria for the PLwCI:

* Diagnosis of Alzheimer's Disease and Related Dementias (ADRD), or caregiver-reported probable or possible cognitive impairment based on electronic medical records or prescribed medications or
* Montreal Cognitive Assessment (MOCA) score between 12 and 24;
* Had ≥1 sleep problem ≥3x/week on the Neuropsychiatric Inventory (NPI)-Nighttime Behavior Subscale;
* Have an eligible caregiver;
* Be able to participate meaningfully in an interview

Inclusion Criteria for Caregivers:

* ≥18 years old, co-residing with persons living with cognitive impairment (PLwCI);
* Regularly assist the care recipient with ≥1 of 7 basic activities of daily living or
* ≥1 of 7 Instrumental Activities of Daily Living for the past 6 months;
* Have a Pittsburgh Sleep Quality Index (PSQI) of 5 or greater

Exclusion Criteria:

* PLwCI: Moderate to severe cognitive impairment
* Individuals who are not yet adults
* Pregnant women
* Prisoners
* Individuals who are not able to clearly understand English.
The Effect of Aroma Massage on Constipation

Advancing age arising changes in health status and systems adversely affect the quality of life of the elderly and the elderly face many complex health problems. Constipation is one of the common problems in the elderly. Therefore, The aim of this study is to examine effects of aromatherapy massage on constipation in the elderly.

Old age is a physiological period of life in which various changes take place, meaning that the elderly must be given special consideration as a group with regard to health care. Advancing age arising changes in health status and systems adversely affect the quality of life of the elderly and the elderly face many complex health problems. Constipation is one of the common problems in the elderly. Insufficient liquid intake, insufficient or unsuitable diet, decreased mobility, the side effects of medication, underlying diseases, and rectal sensory-motor dysfunction are among the causes of constipation in the elderly. Constipation is a preventable and treatable problem, which if left untreated can cause physical and associated psychological problems such as back and waist pain, rectal pressure, loss of appetite, confusion, incontinence, nausea and vomiting, urinary dysfunction, fissure, rectal prolapse, hemorrhoids, intestinal obstruction, and syncope. Constipation can be managed using pharmacological methods, such as laxatives, enemas, suppositories, along with nonpharmacological procedures, such as changes in nutritional habits, fluid intake, education, activities to develop healthy intestinal habits, exercise, massage, aroma massage, biofeedback, stress management and acupuncture.

Eligibility Criteria:
Inclusion Criteria:

* 65 years and older
* Communication and cooperation can be established
* Conscious,, agreeing to participate in the research,
* Decreasing bowel movements, not able to deactivate for 3 days or more
* Living more than two of the complaints related to defecation, who have not undergone intestinal surgery before
* Lesion or infection that disrupts skin integrity in the abdominal region, elderly without any problems such as heart disease and dementia

Exclusion Criteria:

* had language problems
* were below 65 years of age and
* refused to participate in the study.
Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients

The primary objective of the study is to show similarity of efficacy on Pulmicort Respules 1.0 mg/day or 2.0 mg/day for 6 weeks in the treatment period and the corresponding doses of Pulmicort Turbuhaler 400 μg/day or 800 μg/day for 4 weeks in the observation period in Japanese adult asthmatic patients with age of 16 years or older.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* A minimum of 6 months documented history of asthma according to the JGL 2006 definition
* Asthma patients under prescribed treatment with ICS at least 3 months before Visit 2.

Exclusion Criteria:

* Current or previous tobacco smokers with a history of \>= 10 pack-years
* Use of β-blockers including eye drops
* Clinically significant respiratory infection affecting the asthma, as judged by the investigator(s) within 4 weeks prior to visit 2
* Intake of oral, rectal or parenteral GCS within 4 weeks prior to Visit 2
Evaluation of the Use of the Colli-Pee Device to Collect First-void Urine for Molecular Detection of STIs

Study objectives:

* To evaluate the usability of the Colli-PeeTM device to collect first-void urine for nucleic acid detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and Mycoplasma genitalium.
* To collect feedback on the easiness of use and the willingness of future use of the Colli-PeeTM device.

Study population:

The Colli-Pee study is a sub-study of the Be-PrEP-ared study (EudraCT number: 2015-000054-37). All participants who participate in the Be-PrEP-ared study will be asked to participate in this sub-study.

Study design:

Participants who agree to be included in this study will be asked to collect first-void urine using the Colli-PeeTM device the day after the baseline, month 6, month 12 and month 18 visit. They will be asked to send the urine container back to ITM using regular mail. In addition they will also be asked to complete a small questionnaire concerning the easiness of use and the willingness of future use of the Colli-PeeTM device at the enrolment visit and final visit of the Be-PrEP-ared study.

Eligibility Criteria:
Inclusion Criteria:

* Participating in the Be-PrEP-ared study
* Willing to collect first-void urine the next day and to send it back to ITM using regular mail.

Exclusion Criteria:

* none
Alternative Treatment of Giant Spinal Schwannomas

Schwannomas are benign tumors that can reach giant sizes. The diagnosis and treatment of these cases differ from those of small schwannomas. The aim of this study was to review the diagnoses and surgical approach characteristics of the giant spinal schwannomas (GSS) of patients who underwent surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with benign spinal schwannoma Sridhar Type III, IV and V

Exclusion Criteria:

* Malign spinal schwannoma
* Sridhar Type I and II
Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR (Controlled Release)

The purpose of study was to characterize the safety and tolerability of long-term repeated dosing of OROS hydromorphone controlled release tablets (8,16,32, and 64 mg) in patients with chronic cancer pain or chronic non-malignant pain.

This was a Phase 3, multicenter, open-label, extension study to characterize the safety and tolerability of long-term, repeated dosing of OROS hydromorphone in patients with chronic cancer or chronic non-malignant pain. Patients with chronic cancer or chronic non-malignant pain had completed an OROS hydromorphone short-term study (DO-104, DO-105, DO-119) of approximately 4 weeks duration. During this study, patients continued to receive the dose of OROS hydromorphone that they had been receiving in the short-term study, with dose adjustments as needed to control pain and adverse events. Patients were treated on an outpatient basis. The study was extended from 1 year to up to 2 years in duration. Monthly evaluations of patients treated with OROS hydromorphone for chronic pain were performed to identify adverse events, construct a safety and tolerability profile, and assess efficacy. Dose adjustments were permitted to provide for disease progression, pain control, and adverse events. Quarterly physical examinations were performed to detect significant changes in the underlying condition of patients or changes that may have been associated with long-term opioid therapy. OROS hydromorphone 24 hour controlled release tablets in 8, 16, 32 and 64 mg were ingested orally daily up to 1 year with dose adjustments as needed to control pain and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have chronic cancer or chronic non-malignant pain, including pain associated with AIDS, who have successfully completed a OROS hydromorphone HCI (controlled release) short-term study (i.e. Study DO-104, DO-105, or DO-119)
* Patients who require at least 8 mg of hydromorphone HCI every 24 hours for the management of chronic cancer or chronic non-malignant pain
* Patients whose opioid requirements have been stable as demonstrated in a OROS hydromorphone HCI (controlled release) short-term study

Exclusion Criteria:

* Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
* Patients who are pregnant or breast-feeding
* Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs
* Patients with clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
* Patients with any significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition
* Patients who are known active drug abusers or alcoholics
Titration Study of ABX-1431

This study is designed to identify a titration regimen of ABX-1431 in adults with neuropathic pain with satisfactory tolerability to central nervous system (CNS) adverse events (AEs). During the course of this study, each participant will take a daily dose of ABX-1431 or a matching placebo for 28 days.

This is a double-blind, placebo-controlled, optimized titration study of ABX-1431 HCl. The study will explore whether patients experiencing ABX-1431-related CNS AE accommodate or become tolerant to them with continued dosing. The efficacy of ABX-1431 in treating neuropathic pain will be assessed by the change from baseline in pain intensity scores using numerical rating scale (NRS-11).

All patients will undergo a screening visit for enrollment criteria. Eligible patients will be treated with daily medication for 28 days which will include some treatment with placebo and some treatment with ABX-1431 HCl. Patients will record their daily average pain using a paper numerical rating scale (NRS-11).

This study will enroll up to 32 patients with peripheral neuropathic pain due to one of the four following diagnostic groups: post-herpetic neuralgia, diabetic peripheral neuropathy, small fiber neuropathy or post-traumatic neuropathic pain.

Eligibility Criteria:
Key Inclusion Criteria:

* Patient is a male or female over the age of 18 years of age at the Screening Visit.
* Patient has a peripheral neuropathic pain in one of the following diagnostic groups that is persistent for \> 3 months

  * Post-herpetic neuralgia
  * Diabetic peripheral neuropathy
  * Small fiber neuropathy
  * Post-traumatic neuropathic pain
* Patient's median NRS-11 pain intensity score must be ≥ 4 during the baseline period
* If a patient enters the trial on daily background neuropathic pain medications, then the patient must be on stable dose of medications for at least 30 days before enrollment and throughout the study.
* Patient is able to understand and comply with the protocol procedures for the entire trial and must give written informed consent.
* Men and Women must agree to a medically approved contraceptive regimen.

Key Exclusion Criteria:

* Patient is taking potent cytochrome P450 3A4/5 inducers or inhibitors
* Patient has received injection therapies (e.g., botulinum toxin, anesthetic or nerve block) or transcutaneous electrical stimulation to control pain in the past 60 days
* Patient has evidence of alcohol, drug or chemical abuse in the year before the Screening Visit.
* Patient is a lactating or pregnant female or a female who intends to become pregnant within 90 days following the last dose of investigational product.
* Patient has specific laboratory abnormalities

Other protocol-defined inclusion/exclusion criteria may apply.
A Clinical Study of 6MW3211 in Patients With Renal Cancer

single arm, non-randomized, multicenter, open label, phase 2 clinical trial in patients with advanced clear cell renal cacer

This study is a single arm, non-randomized, multicenter, open label, phase 2 clinical trial to evaluate preliminary efficacy and safety in patients with advanced clear cell renal cacer

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate in the study and sign the informed consent.
* Advanced clear cell renal cancer.
* At least one measurable tumor target lesion.
* Life expectancy≥3 months.
* Suitable organ functions.
* Patients who had failed at least one line therapy.
* ECOG 0-1.
* The samples of tumor tissue should be provided

Exclusion Criteria:

* Patients who had received anti-tumor therapy/radiotherapy/immunotherapy within 4 weeks.
* History of other malignant tumors within 5 years.
* Patients with CNS metastasis.
* History of active autoimmune diseases.
* Patients with poor-controlled systemic diseases after treatment.
* Patients with severe infection or requiring antibiotic treatment within 4 weeks before dosing.
* Adverse reactions related to previous treatments failed to recover to CTCAE 5.0 ≤1
* Patients who had experienced immune-related adverse events (irAE) with grade 3 or above.
* Patients who were allergic to any composition of experimental drug.
* Subjects with poor treatment compliance.
* Pregnant or lactating woman.
* Live vaccination within 28 days before first dosing.
* History of drug abuse or addiction
* Patients with active HBV or HCV, or HIV antibody positive,or Tp-Ab positive.
Omega-3 Fatty Acids for Major Depressive Disorder During Pregnancy

Whether high-dose omega-3 fatty acids supplement would be an effective treatment in patients with major depressive disorder during pregnancy and breast-feeding.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants were pregnant women, aged 18 to 40 years, with major depressive disorder onset between their 16th week (second trimester) and 32nd week (third trimester) of gestation at the Department of Obstetrics.

Exclusion Criteria:

* Subjects were excluded with a DSM-IV diagnosis of bipolar disorders, psychotic disorders, substance abuse or dependence for at least 3 months, or any Axis-II diagnosis of borderline or antisocial personality disorder.