cyrilzakka/clinical-trials huggingface dataset:
Therapies for Treatment-Resistant Panic Disorder Symptoms

This study will determine the effectiveness of different treatments for panic disorder symptoms in individuals who still have symptoms after initial treatment with medication.

Panic disorder is a serious condition that may cause significant psychological and physical distress. Many patients with panic disorder remain symptomatic despite initial intervention. Unfortunately, little data is available to guide health care providers in "next-step" treatment approaches. This study will evaluate the effectiveness of treatments for individuals with panic disorder that is resistant to initial treatment with selective serotonin reuptake inhibitors (SSRIs).

This study will last 24 weeks and will comprise three phases. In Phase 1, participants will receive the SSRI sertraline for 6 weeks. Phase 1 will be used to determine participants' resistance to treatment. During Phase 1, participants will begin a medication schedule and symptom diary and will have weekly study visits to assess regimen adherence and any side effects they may be experiencing. In Phase 2, participants will be randomly assigned to 6 weeks of one of two treatments: sertraline at an elevated dose from that given in Phase 1 or a sertraline and placebo regimen. During Phase 2, participants will have 3 study visits. Self-report scales and diary entries will be used to assess panic disorder symptoms and medication side effects. In Phase 3, participants will be randomly assigned to receive either cognitive behavioral therapy (CBT) or sertraline and clonazepam for 12 weeks. All participants will have weekly study visits during Phase 3. Questionnaires and self-report scales will be used to assess participants at the end of Phase 3.

Study hypothesis: Combined selective serotonin reuptake inhibitors (SSRIs) and benzodiazepine treatment, increasing the dose of SSRI, and the addition of cognitive behavioral therapy (CBT) each may have benefits for patients with panic disorder who remain symptomatic after initial treatment with SSRIs.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of panic disorder

Exclusion Criteria:

* History of bipolar disorder, schizophrenia, psychosis, or delusional disorders
* Post-traumatic stress disorder diagnosis within 6 months prior to study entry
* Current use of psychotropic medications
* Current use of cognitive behavioral therapy
Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM

The purpose of this study is to infuse BCMA CAR-NK 92 cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK-92 cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years to 80 years, expected survival \> 3 months
2. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry
3. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease
4. ECOG performance status of 0 - 1
5. Cardiac function: 1 - 2 levels; Liver: TBIL ≤ 3ULN，AST ≤ 2.5 ULN，ALT ≤ 2.5ULN; kidney: Cr ≤ 1.25ULN
6. No serious allergic constitution
7. No other serous diseases that conflicts with the clinical program
8. No other cancer history
9. Female participants of reproductive potential must have a negative serum pregnancy test
10. Subjects must have signed written, informed consent

Exclusion Criteria:

1. Pregnant or lactating women
2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive
3. Active hepatitis B or hepatitis C infection
4. Recent or current use of glucocorticoid or other immunosuppressor
5. Serious mental disorder
6. With severe cardiac, liver, renal insufficiency, diabetes and other diseases
7. Participate in other clinical research in the past three months
8. Previously treatment with any gene therapy products
Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis

Premalignant AKs are highly frequent in the light-skinned populations with an increasing incidence. PDT is considered a well-establish treatment for these lesions, and therefore it is essential to achieve an optimal and effective treatment as possible. The present study proposes a new post-treatment modality with application of an anti-inflammatory moisturizer Cicaplast Baume B5+ to the treated areas that may improve the overall patient satisfaction and minimize the local skin reactions. Treatment regime consists of two daily applications of Cicaplast Baume B5+ for 14 days, and this regime is not associated with increased risk of systemic AEs or serious events.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. \> 18 years of age or older at baseline
3. Fitzpatrick skin type I-III
4. Clinical AKs in two symmetrical areas on the face or on the chest, presented with at least ten AKs
5. Female subjects of childbearing potential must be confirmed not pregnant by negative pregnancy test prior to study inclusion and must use a safe contraceptive method during the study

Exclusion Criteria:

1. Previous exposure to PDT, energy-based devices, or AK treatment on the study areas within 3 months
2. Pregnant or lactating women
3. Patients with known allergy to MAL or any ingredients in Cicaplast, Baume B5+
4. Concomitant treatment with immunosuppressant drugs
5. Infiltrating tumors in the treatment areas
6. Known porphyria
7. Other skin diseases present in the test area at baseline
8. Non-eligibility at the discretion of the investigator (e.g. non-compliance, unavailability or other reasons the subject is not believed to be able to comply with the clinical trial protocol)
A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis

The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics of multiple doses of BGS649 with concurrent daily administration of combined oral contraception in patients with refractory endometriosis


Eligibility Criteria:
Inclusion Criteria:

* Must have surgical diagnosis of endometriosis est. w/in 5 years before screening. Subjects must have self reported moderate to severe pelvic pain at screening to be confirmed during the run-in-phase
* Subjects with moderate to severe pelvic pain who were refractory to surgery (persistent or recurrent pelvic pain within 24 months after any therapeutic surgery) and at least two hormonal therapies from two different classes, including one approved hormonal therapy

Exclusion Criteria:

* Subjects who have undergone hysterectomy or bilateral oophorectomy.
* Surgical treatment of endometriosis within 3 months before screening.
* Subjects who are pregnant or who were pregnant within 3 months of visit one.
* Subjects who are nursing or lactating
* Subjects who are tobacco smokers.

Other protocol-defined inclusion/exclusion criteria may apply
Experiences of Psychotherapeutic Outcomes in Women Victims of Domestic Violence

The main objectives of the study are:

1. To explore the experience of undergoing psychotherapy of women victims of domestic violence.
2. To explore the effects of undergoing psychotherapy among women with victims of domestic violence.

Participants:

Purposive sampling techniques would be followed to inquire about the data from the sample. The sample of the present study would be the women who are victims of domestic violence. The study's sample size is 15 which pre and post-testing would be implied. The participants were briefed about the objectives of the present study. Informed consent was taken to ensure the willingness of the participants. First, the DASS test is fulfilled to check out the symptoms caused by domestic violence in women. To fulfill the criteria, they inquired about the topic in detail to get in-depth information from the participants about their experiences and mental health problems caused by domestic violence. Later, they were provided with psychotherapeutic sessions to treat or reduce their mental health problems, and again an in-depth interview about these therapy sessions was conducted to check the effectiveness of the treatment given.

Eligibility Criteria:
Inclusion Criteria:

* the participants that would be included in the study are females who would be victims of Domestic Violence with the age range of 18 years to 45 years and women who would be eligible for taking psychotherapeutic intervention

Exclusion Criteria:

* women with psychotic disorders would be excluded and those who wouldn't meet the criteria of the DASS test
Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer

This randomized phase III trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologic proof of primary squamous cell carcinoma of the esophagus.
* Primary disease at cervical, upper or middle thoracic esophagus
* T1-4, N any, M0 (except supraclavicular lymph node).
* Age≥18 \& ≤75.
* ECOG score 0-2.
* Platelets ≥ 150,000, Hgb ≥ 10 gm%, ANC ≥ 1500, serum creatinine ≤ 1.5 mg/dl.
* Adequate liver function.
* Patients with prior malignancy are eligible if disease-free ≥ 5 years.
* No prior chest radiotherapy, systemic chemotherapy or major esophageal surgery.
* Signed study-specific informed consent form prior to study entry.

Exclusion Criteria:

* Patients with tracheo-esophageal fistula.
* Patients with invasion into mucosa of trachea or major bronchi.
* Patients with uncontrolled serious medical or mental illnesses.
* Prior RT that would result in overlap of planned RT fields.
* Pregnancy or women of childbearing potential and men who are sexually active
* Women who are breastfeeding a baby.
Health Evaluation of Abilify Long-term Therapy

This is a post-market surveillance, and the treatment to patients will be depended upon the decision based on physician's clinical judgment. The health profiles during the switching period, after 12 weeks short-term use, and after 52 weeks long-term use of aripiprazole will be recorded and evaluated.

Further study details as provided by Taiwan Otsuka Pharmaceutical Co., Ltd.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients between the ages of 18 to 65.
2. Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
3. Who are currently taking antipsychotic drugs and clinically intolerable or inadequately controlled that is based upon the clinical judgment of the investigator.

Exclusion Criteria:

1. Pregnant or breast feeding women or planning a pregnancy.
2. Patient received electroconvulsive therapy within 4 weeks before the Screening Visit.
3. A known allergy reaction to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).
4. Patient has clinically relevant organic, neurological, or cardiovascular diseases.
5. Patient has a history of drug or alcohol abuse within the last 12 weeks.
6. Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.
7. Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
8. Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.
9. Depot neuroleptics should be discontinued at least 2 months prior to enrollment.
New Oral Direct Anticoagulants in Patients 80 Years Old and Over : a Population Pharmacokinetics Study

Several new oral direct anticoagulants have been recently marketed. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study.

Several new oral direct anticoagulants have been recently marketed. A main indication for taking these drugs is atrial fibrillation and, in everyday practice, most patients with atrial fibrillation are older people. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. Furthermore, this limited data strongly suggests that, in older patients, mean concentrations, overall exposition and half-live of these drugs are increased, as compared with younger people. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study. This is, many people (projected 225 patients) will have a few blood samples each and all data will be pooled using statistical methods specific to this kind of studies. Each patient will have one to five blood samples, taken at te same time that routine blood analysis, to determine plasma concentrations of the studied drug. In addition, patients will be followed for thrombotic and haemorrhagic events at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 80 years or older
* Under treatment with dabigatran, rivaroxaban or apixaban
* For non-valvular atrial fibrillation

Exclusion Criteria:

* Mechanical (non-biological) heart valve
* Any severe condition leading to a short estimated life expectance (a few months)
Effects of 'NHGDoc' on Quality of Care

The purpose of this study is to determine whether the computerized decision support system 'NHGDoc' is effective in improving quality of primary care in terms of processes of care (e.g. prescribing behavior of physicians) as well as outcomes of care (e.g. hospital admissions, mortality).

Computerized decision support systems are regarded as useful tools to improve quality of care, but their effects are still uncertain. In the Netherlands 'NHGDoc' a computerized decision support system supported by the Dutch College of General Practitioners (NHG) is currently being implemented among more than 1.000 general practices in the Netherlands.

The aim of this study is to evaluate the effects of NHGDoc on quality of care. In addition, we want to gain insight into the barriers and facilitators that affect the systems' impact.

A cluster randomized controlled trial will be conducted among 120 general practices in the Netherlands. Eligible practices will be randomized to receive either the regular NHGDoc modules (control arm) or the regular modules and an additional module on heart failure (intervention arm). The effect evaluation will focus on processes of care (e.g. prescription behavior) as well as on patient outcomes (e.g. hospital admissions, mortality). Additionally, a process evaluation will be conducted, which includes a focus group study and a survey among participating healthcare providers to evaluate the perceived barriers and facilitators to using 'NHGDoc'.

Results of this study will provide insight in the ability of computerized decision support systems and in particular 'NHGDoc' to improve quality of primary care. Whereas the trial focuses on a specific NHGDoc domain - heart failure - we believe our conclusions are relevant to other primary care areas as well, particularly as this study also explores the factors that contribute to the systems' effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* General practices should use the information system MicroHIS X or Promedico ASP
* NHGDoc should be available in the general practices

Exclusion Criteria:

* General practices that do not meet the inclusion criteria
Hyperosmolality and Acute Kidney Injury After Cardiac Surgery

The goal of this randomized controlled trial is to test if a hyperosmolar prime solution used for cardiopulmonary bypass increases the risk for acute postoperative kidney injury.

Two-hundred cardiac surgical patients were randomised into two groups based on the osmolality level of the prime solution used for cardiopulmonary bypass. The high osmolality group (966 mOsm) received a prime solution containing Ringer-Acetate 1000 ml + Mannitol 400 ml (60 g) + Sodium-Chloride 40 ml (160 mmol) and Heparin 2 ml (10 000 IU), while the reference group with normal osmolality (388 mOsm) received a prime solution containing Ringer-Acetate 1400 ml and Heparin 2 ml (10 000 IU).

Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for routine cardiac surgical procedures requiring cardiopulmonary bypass.

Exclusion Criteria:

* Patients requiring acute surgical intervention within 24 h or profound hypothermia during surgery were excluded.
Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis

The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.

Monthly Erythropoiesis-Stimulating Agents (ESA) dosing, compared with the longstanding practice of dosing three times per week, represents a significant change in anemia treatment for dialysis patients. Because of the differences in the processes needed to support monthly dosing versus thrice weekly dosing, there is a need to prospectively identify and evaluate factors in the dialysis environment during center-level transition of patients from one ESA to another.

AFX01-18 is a Phase 3b open-label, single-arm conversion study that was conducted at 5 hemodialysis sites in the United States, and enrolled Chronic Kidney Disease (CKD) patients receiving outpatient, in-center hemodialysis. The study treatment period was approximately 12 months in duration. Participants received peginesatide injection for approximately six months.

Eligibility Criteria:
Inclusion Criteria:

* Have provided written informed consent in accordance with institutional, local, and national guidelines
* Are ≥18 years of age at the start of screening
* Have been on in-center hemodialysis for ≥12 weeks at the start of screening
* Are currently maintained on Epoetin at the start of screening
* If sexually active and a female of childbearing potential, are willing to use highly effective method of birth control ≥4 weeks before study enrollment and through the study
* If a female of childbearing potential, have a negative pregnancy test during screening

Exclusion Criteria:

* Are scheduled for a renal transplantation during study (Note: patients awaiting transplantation with no date scheduled may enroll.)
* Have an active malignancy or malignancy treated within one year prior to the start of screening for curative or palliative intent (Note: patients with non-melanoma skin cancers may enroll.)
* Have known intolerance to any ESA or PEGylated molecule
* Have been exposed to any investigational agent during the four weeks prior to the start of screening or are anticipated to receive such agents during the study
* Have any significant medical or psychiatric condition judged by the investigator to prevent informed consent or study compliance
* Are pregnant or nursing
Comparison of the Diagnostic Accuracy of Hysterosalpingo-lidocaine-foam Sonography Versus Hysterosalpingography in Tubal Patency Assessment to the Gold Standard of Laparoscopy and Dye Testing

This is a cross-sectional study that compares the diagnostic accuracy of Hysterosalpingo-lidocaine-foam sonography combined with power doppler (HyLiFoSy-PD) in the assessment of tubal patency, with the diagnostic accuracy of hysterosalpingogram (HSG), and to the gold standard of laparoscopy and dye testing.


Eligibility Criteria:
Inclusion Criteria:

1. Age group (18-40)
2. Informed signed Written consent.
3. Scheduled for LDT as a part of their infertility management
4. Have undergone HSG in the previous 5 years with the availability of good-quality HSG images.
5. No incident factors that might have affected the tubal status after she underwent HSG within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.

Exclusion Criteria:

1. LDT scheduled for a therapeutic purpose due to a known tubal or ovarian pathology
2. Lack of good-quality HSG images.
3. Withdrawal of consent.
4. Using contraception
5. Women outside reproductive age
6. Known allergy to lidocaine
7. Active pelvic inflammatory disease
8. Undiagnosed genital tract bleeding.
9. Evident tubal pathology (such as hydrosalpinx) or pregnancy diagnosed by transvaginal ultrasound (TV-US) prior to performing HyLiFoSy-PD 10- Incident factors that might have affected the tubal status after she underwent HSG within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.
Prevention Ventilator Associated Pneumonia

The objective of the investigators work was to evaluate the impact of 4 sequentially implemented measures for preventing VAP in a major heart surgery ICU. The measures were a specific training program, aspiration of subglottic secretions (ASS), introduction of an inclinometer to improve the semirecumbent position, and reinforcement of oral care with chlorhexidine.


Eligibility Criteria:
Inclusion Criteria:

* all patients with heart surgery admitted in critical care unit during the study period

Exclusion Criteria:

* none
A Pilot Study of TRV130 for the Treatment of Fracture Pain

The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe acute pain in patients presenting to the emergency department (ED) with a suspected/known, unilateral, closed long bone fracture.

This study is designed to evaluate the analgesic efficacy of TRV130 for the treatment of moderate to severe acute pain associated with a long bone fracture in patients presenting to the ED. The safety and tolerability of TRV130 will also be evaluated in this open-label pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years, inclusive
* Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both) OR tibia, fibula (or both) BUT not fractures in more than 1 extremity
* Able to understand and comply with study procedures and requirements, and provide written informed consent

Exclusion Criteria:

* Significant concomitant head, chest, or abdominal trauma
* Multiple extremity trauma
* Open fracture
* Clinically significant medical condition or history of such condition that may place the patient at an unacceptable risk in the trial, may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs