cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study of 6MW3211 Injection in the Treatment of Relapsed/Refractory Lymphoma

This study is a single arm, non-randomized, open label phase 2 international, multicenter clinical trial to evaluate preliminary efficacy and safety in subjects with relapsed or refractory lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate in the study and sign the informed consent.
* Age≥18 years.
* Subjects with relapsed or refractory lymphoma.
* Subjects with at least one measurable tumor lesion.
* ECOG 0-2.
* Life expectancy≥3 months.
* Adequate organ functions.

Exclusion Criteria:

* Subjects who had received anticancer therapy or radiotherapy within 21 days or 5 half-lives (whichever is shorter) before enrollment or received adoptive cellular immunotherapy within 12 weeks.
* Subjects who had received allogeneic hematopoietic stem cell transplantation or organ transplantation or received autologous hematopoietic stem cell transplantation within 3 months.
* Subjects with primary or secondary CNS lymphoma.
* History of another malignancy within 3 years before the first dose of investigational drug.
* History of active autoimmune diseases.
* Systemic immunosuppressive therapy within 2 weeks prior to the first dose of investigational drug.
* Subjects who experienced grade 3 or above immune-related adverse events (irAE) .
* Documented history of uncontrolled systemic diseases.
* Subjects who were allergic to any composition of investigational drug.
* Major surgery within 28 days prior to first dose of investigational drug.
* Subjects with active infection.
* Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
* Subjects with poor treatment compliance.
* Use of any investigational drug or device within 28 days prior to the first dose of investigational drug.
* Live vaccine was administered within 28 days prior to first dose of investigational drug.
* Pregnant or lactating women.
The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate Traumatic Brain Injury (TBI) Patients

In this study of patients with moderate traumatic brain injury with frontal brain contusions patients will be randomized to treatment with a single dose of either D-cycloserine or placebo given 48-72 hours after injury.

Patients will undergo intensive neurocognitive testing at 3 and 6 months after injury to assess whether treatment with a single dose of D-cycloserine improves cognitive outcome after moderate brain injury.


Eligibility Criteria:
Inclusion Criteria:

1. TBI diagnosed by history and/or clinical examination with presenting GCS between 9 -13
2. Age between 18 and 55 years
3. Frontal cerebral contusion(s) located in the frontal cortex and/or traumatic subarachnoid hemorrhage on initial CT scan
4. Prior to randomization, patient is able to swallow an orally administered tablet or has a nasogastric tube in place per medical indication
5. Informed consent will be obtained in those patients who have regained full cognition and judgment following their injury and are fully capable of understanding the study protocol, its risks and potential benefits, and of giving informed consent for participation in the study. In any patient that has not regained full cognition and judgment, only a temporary legal guardian (apotropos) appointed by an authorized judge that has been given a full explanation of the study protocol, its risks and potential benefits will be authorized to give informed consent for participation in the study.

Exclusion Criteria:

1. Penetrating brain injury
2. Any traumatic intracranial lesion requiring neurosurgical intervention prior to time of randomization
3. Other severe systemic injuries leading to severe hypotension, hemodynamic instability following initial resuscitation (SBP \< 90 mmHg), severe hypoxia.
4. Intubation lasting \> 12 hours prior to randomization
5. Suspected or confirmed pregnancy or lactating women
6. Any spinal cord injury
7. Known or CT scan evidence of previous major cerebral damage
8. Any severe concomitant condition (malignancy, renal, hepatic, or major psychiatric disorder)
9. Known treatment with another investigational drug within 30 days of injury
10. Known contraindication to enteral administration of drug prior to randomization (GI bleed, ileus, severe abdominal injury, etc.)
11. Known contraindication to placement of a nasogastric tube in patients unable to swallow an orally administered tablet
Examining the Validity and Reliability of the Dresden Falls Questionnaire in Patients with Parkinson's Diagnosis Living in Turkey

The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ) to Turkish society and to make its validity and reliability in Turkish. The DREFAQ) scale developed by Frank, Anika, et al assesses falls in patients with Parkinson. It has 5 questions. This study will be conducted with Parkinson patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 50 participants will be included in the study. In order to evaluate the validity of the DREFAQ, the Modified Falls Efficacy Scale (MFES), which can evaluate the efficacy of falls and has been validated in Turkish, and the Parkinson's Disease Quality of Life (PDQOL) questionnaire, which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion.

The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. If the developer of the scale, Frank, Anika, et al approves the translation of the scale, participants will be recruited for the study. In the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of DREFAQ will be able to be modified. The data of DREFAQ are collecting through face-to-face when the patients came to the rehabilitation center. 50 participants will be included in the study.

In order to evaluate the validity of the DREFAQ, the Modified Falls Efficacy Scale (MFES), which can evaluate the efficacy of falls and has been validated in Turkish, and the Parkinson's Disease Quality of Life (PDQOL) questionnaire, which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a Hoehn \& Yahr score between 1-4,
* Individuals who can ambulate with or without assistive equipment,
* Individuals with a Mini Mental State Examination score of \>24,
* Individuals with a history of falling at least once in the last year,

Exclusion Criteria:

* communication or cognitive problems,
* aphasia and speech disorders
* unstable medical conditions
Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00

The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.

This study will be conducted in regions where the test article is approved at the time of study start.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision;
* Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
* Clear intraocular media other than cataract in both eyes;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
* Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies;
* Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;
* Pregnant or lactating;
* Expected to require ocular surgical or retinal laser treatment;
* Other protocol-specified exclusion criteria may apply.
Exercise and Relaxation Intervention for Young Adult Cancer Survivors

The purpose of this study is to develop an exercise and relaxation program for young adults (age 18 to 39) who have completed their treatment for cancer.

There is evidence that cancer diagnosis and treatment during young adulthood puts survivors at risk for a number of medical and psychosocial difficulties including cardiovascular disease, second cancers and psychological distress. The proposed research is aimed at developing a physical activity and relaxation intervention for young adult cancer survivors in order to address some of their medical and psychosocial risks. The objective of the study is to pilot test a 12-week physical activity and relaxation intervention in this population. We hypothesize that the intervention will be feasible for and acceptable to young adult cancer survivors. We also hypothesize that the intervention group will demonstrate increased levels of physical activity, improved mood and reduced fatigue relative to the wait list control group at the 12-week and 24-week follow-up assessments; statistically significant differences may not be found due to the small sample size, however. In addition, we will conduct exploratory tests of intervention effects on fitness, flexibility, body mass, and waist circumference. Sixty participants will be recruited for the pilot study. Participants will be randomly assigned to receive a 12-week physical activity and relaxation intervention or to a wait list control group. Intervention group participants will receive 12 weeks of behavior change counseling, based on the Transtheoretical Model and Social Cognitive Theory, to help them adopt a program of brisk walking and learn mindfulness meditation. They will also be given access to an online discussion group. Participants in both arms of the study will be assessed at baseline, 12 weeks, and 24 weeks. Following the 24-week assessment, wait list control participants will offered the 12-week intervention and one additional assessment (i.e., at 36 weeks). Data will be collected on intervention feasibility (e.g., number of counseling sessions delivered) and acceptability (e.g., general satisfaction ratings). ANCOVAs will be used to conduct preliminary tests of intervention effects (e.g., on physical activity, mood, and fatigue).

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 39
* diagnosed with any form of cancer (except non-melanoma skin cancer)
* diagnosed between age 18 and 39 in the past 10 years
* completed all surgery, chemotherapy and radiation therapy
* currently in a cancer remission
* able to speak and write English fluently
* sedentary (i.e., not regularly physically active)
* not currently engaging in a relaxation strategy
* score above a cutoff on a fatigue screener

Exclusion Criteria:

* the intention to get pregnant
* the presence of a known medical condition or history of severe psychiatric illness that would make participation dangerous or very difficult
Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women

The purpose of this study is to investigate the anti-atherosclerotic and anti-climacteric action of natural drug Karinat based on phytoestrogen-rich botanicals in perimenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Perimenopausal women aged 45 to 60 years with intact womb and ovaries
* The absence of menstruations between 6 to 24 months
* Last menstruation after the age of 40 years
* Follicle-stimulating hormone (FSH) blood level ≥ 35 ng/ml
* Mammography without nodal form of mastopathy or breast cancer signs
* Absence of hypolipidemic therapy or HRT (hormone replacement therapy) during 6 months before the inclusion

Exclusion Criteria:

* Administration of lipid-lowering drugs, and/or HRT, and/or phytoestrogens during 6 month before inclusion
* Personal history or diagnostic of following diseases:

nodal form of mastopathy or breast cancer any cancer except non-melanoma skin cancer stroke or myocardial infarction chronic renal failure II-III chronic hepatic failure II-III liver cirrhosis chronic heart failure IIa-III exacerbation of chronic stomach or duodenal ulcer obesity (BMI \>30 kg/m2) alcohol abuse uncontrolled arterial hypertension (systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 90 mmHg) current cigarette smoking (\>10 cigarettes a day) diabetes mellitus deep vein thrombosis or pulmonary embolism

* Individual intolerance of Karinat or major side effects
Emotional Problems in Preschool Children: Evaluation of the SuperKids Program (PRE-KIDS)

Emotional problems are among the most frequent psychological problems in the school stage, having an early onset. When they are not detected and they do not receive adequate intervention, they persist and become chronic, being considered precursors of other problems in adolescence and adulthood. The early onset of emotional problems, and their precursor role for other disorders, justify the need for preventive interventions as soon as possible. Since there is evidence that anxiety and depression share common underlying mechanisms, preventive programs should address shared risk factors. For this reason, the objective of this study is to test the effectiveness of an 8-session cognitive-behavioral protocol developed for Spanish children aged 4 to 6 in the educational context in a controlled trial. The objective of the program is that children improve their skills to manage their own emotions and to improve their ability to interact with other. The program will be applied ina group format and will be enriched with multimedia material that the implementer will project at various moments of the sessions.

A 2 x 3 factorial design will be used, with the intervention variable as an intergroup factor (intervention or waiting list), and with the evaluation phase as an intragroup factor (pretest, posttest, 12 months follow-up). Parents and children will complete the same measures at baseline, post-treatment, and follow-up. The investigators will compare the results of pre- and post-assessments of children participating in the program on emotional and social variables.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4 to 6 years.

Exclusion Criteria:

* Intellectual disability, behavioral symptoms or autistic spectrum symptoms whose severity prevented the continuation of treatment.
* Current psychological or pharmacological treatment for anxiety and/or depression.
* Not accepting or revoking informed consent to participate in the study.
Alternative Blood Pressure Measurements in OB Patients

The incidence of obesity has been increasing worldwide. In women with obesity, the anthropometric differences in the distribution of subcutaneous tissue can make accurate measurement of blood pressure difficult. A large upper arm circumference can prevent the use of a brachial artery blood pressure cuff and often prompts the use of alternative methods for blood pressure measurement, including measurements on the wrist or forearm. Outside of the obstetric population, there is evidence that if measurement of the blood pressure at the upper arm is not possible then measurement at the wrist can be used. Despite this evidence in non-pregnant patients, there is limited evidence in pregnancy regarding the accuracy of blood pressure measurements on the forearm or wrist. Accurate measurement of blood pressure is especially important in pregnancy to allow for prompt treatment of severe hypertension and for accurate diagnosis of hypertensive disorders of pregnancy. Error in measurement could lead to iatrogenic preterm birth or under treatment of severe hypertension, both which can lead to severe maternal and fetal morbidity and mortality. Additionally, it is biologically plausible that an increase in subcutaneous edema and vascular changes in pregnancy could lead to a larger discrepancy in blood pressure measurements between upper arm, forearm and wrist measurements.

Due to the increasing epidemic of obesity and the increasing need for accurate alternative blood pressure measurements the investigators propose a prospective observational study of pregnant women ≥18 years old admitted to labor and delivery for any indication or seen for prenatal care in OBGYN clinic. A total of 20 women in each BMI class (normal, overweight (25-29.9), class 1 (30-34.9), class 2 (35-39.9), class 3 (\>40) will be enrolled (100 total). Participation will include a total of 9 blood pressure measurements, biometric measurements on the patient's upper arm, forearm, and wrist and a brief questionnaire. The investigators hypothesize that there will be a discrepancy between blood pressure measurements on the upper arm and forearm or wrist.


Eligibility Criteria:
Inclusion Criteria:

* \>=18 years old
* prenatal care at study hospital
* english speaking

Exclusion Criteria:

* Age \<18
* Active upper extremity DVT
* Inability to measure blood pressure on arm
* Unable to give consent
Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.


Eligibility Criteria:
Inclusion Criteria:

1. Are willing and able to sign the informed consent form (ICF);
2. Female and male aged 50 to 85 years (inclusive) with nAMD;
3. Have previously received anti-VEGF treatment for nAMD, with documented response to anti-VEGF therapy and a minimum of 2 anti-VEGF IVT injections in the study eye in the 6 months prior to screening;
4. Have a ETDRS BCVA letter score of 83 to 19 (approximately 20/25 to 20/400 Snellen equivalent) in the study eye at Screening;
5. Have a ETDRS BCVA letter score of ≥19 in the fellow eye at Screening;
6. Females must be at least 1 year postmenopausal.

Exclusion Criteria:

1. Have any other cause of CNV (such as pathological myopia, etc.) in the study eye; or non-nAMD disease in the study eye judged by the investigator that could impact macular examination or affect central vision (such as diabetic retinopathy, central retinal vein occlusion, etc.);
2. Any condition preventing visual acuity improvement in the study eye, e.g. fovea scar, fibrosis or atrophy;
3. Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is greater than 1.0 mm2 under the fovea in the study eye at screening;
4. Have any vitreous hemorrhage or history of vitreous hemorrhage in the study eye;
5. Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination;
6. Have a history of or presence of retinal detachment or choroidal detachment in the study eye.
Physicians' Health Study

To assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene.

BACKGROUND:

Thrombosis plays a major role in the late stages of coronary occlusion. Platelet aggregation is a large component in the formation of arterial thrombi. In pharmacologic studies, aspirin has been shown to inhibit platelet aggregation and, therefore, might be expected to prevent coronary occlusion. These effects are apparent in the dose range of l00-l000 mg/day, and may be most evident at l60 milligrams daily. Higher doses seem to be no more effective in either inhibition of platelet agreeability or prolonged bleeding time.

Although an early case-control study by Jick and Miettinen showed a large benefit, most observational studies had shown a cardiovascular benefit of about 20 percent. Conclusive data could only result from a randomized trial with a large sample size.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. Participants were randomized into one of four treatment groups: one 325 milligram aspirin tablet every other day, alternating with one 30 milligram capsule of beta-carotene; one aspirin every other day, alternating with one capsule of beta-carotene placebo; one aspirin placebo tablet every other day, alternating with one capsule of beta-carotene; and one aspirin placebo tablet every other day, alternating with one capsule of beta-carotene placebo. Major endpoints for the cardiovascular component of the study were cardiovascular mortality, total mortality, and coronary events.

Eligibility Criteria:
Male physicians, ages 40 to 84. No history of stroke, myocardial infarction, cancer, or renal disease. No contraindications to aspirin or beta-carotene. No current usage of aspirin or Vitamin A tables greater than once per week.
Trichotillomania: Group Cognitive-Behavioral Therapy

Objective: Trichotillomania is a psychiatric condition characterized by chronic pulling and plucking of one's own hair. Cognitive behavioral therapy shows promise as a treatment. However, there have been no randomized, controlled studies of the efficacy of group cognitive-behavioral therapy. Methods: We evaluated 44 subjects, whom met the criteria for a diagnosis of trichotillomania. Subjects were randomized to receive 22 sessions of either group cognitive-behavioral therapy or group supportive therapy (control).


Eligibility Criteria:
Inclusion Criteria:

* Patients having been diagnosed with trichotillomania according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria; being at least 18 years of age; and having had four or more years of schooling.

Exclusion Criteria:

* Patients that having been diagnosed with trichotillomania according to DSM-IV criteria; having less of 18 years of age; and having less of four years of schooling.
* Patients with a history of suicidal ideation,
* Patients with any clinical pathology requiring emergency treatment at admission,
* Patients with mental retardation or any other central nervous system disorder that severely impairs cognitive function,
* those with a psychotic disorder,
* those currently being treated with psychotropic drugs,
* those with any DSM-IV axis II diagnosis,
* those who scored ≤ 2 on the MGH-HPS in an initial screening.