cyrilzakka/clinical-trials huggingface dataset:
Positive Affect and Mental Imagery in the Process of Cognitive Behavioural Therapy

Background: Research findings suggested that people with mental disorders show a dysfunctional upregulation of negative affect (NA) but at the same time a dysfunctional downregulation of positive affect (PA) as distinct processes. Nevertheless, established treatment approaches focus on the modification of problems and negative affect only. Experimental paradigms with healthy and subclinical populations showed that PA inductions lead to higher flexibility in information processing, cognitive appraisal and action tendencies. Higher amounts of PA were associated with more personal resources, higher psychological resilience and subjective well-being. Preliminary evidence indicated that a focus on positive and functional aspects in the life of patients lead to better treatment sessions and outcome. However, the role of PA for the process in cognitive behavioral therapy remains unclear.

Method/Design: In regard to this we developed the PACIfIC-study, serving the following objectives:

(1) to explore the trajectories of PA and NA and their association with relevant process variables in an early phase of CBT treatment. (2) To develop and test the feasibility of a brief and easily implementable intervention to promote PA in psychotherapy sessions. (3) To analyze the impact of this intervention on the therapeutic process between and within CBT sessions and intermediate outcomes.

The study includes a randomized contolled, longitudinal design in an outpatient research and treatment center. Both a process and an intervention analysis will be conducted. In the process analysis, we will examine the course of PA and NA in the first twelve sessions of CBT treatments. In the intervention analysis, we will examine the effects of a six-minute positive mental imagery intervention during an early phase of psychotherapy. The aim of this micro-intervention is to foster patients' in-session PA, which may lead to increased levels of subjective resources, resilience, and self-esteem (theory-driven outcome) as well as improvements in psychopathology and working alliance (secondary outcome).

Discussion: The study results may have important theoretical and practical implications on the use of PA in psychotherapeutic treatment. Furthermore an economic implementation of strengths-oriented interventions in psychotherapy practice may be initiated.


Eligibility Criteria:
Inclusion Criteria:

* at least one mental disorder according to DSM-5 criteria
* treatment at the center of Mental Health and Psychotherapy, Witten/Herdecke University; outpatients clinic

Exclusion Criteria:

* current diagnosis of a severe episode of major depressive disorder
* suffering from a psychotic disorder
* suffering from substance use disorder
* current episode of (hypo)mania
* current suicidal risk
* extensive experiences with guided mental imagery intervention
* insufficient German language skills
* currently receiving another psychological treatment
The Impact of a Topical Vasodilating Cream on Female Sexual Experience

The purpose of this study is to determine if a topical vasodilating cream will improve female sexual experience.

To determine in a placebo controlled double blinded study whether a topically applied vasodilating cream will improve the female sexual response as measured by a standard female sexual dysfunction questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Healthy females ages 25 to sixty sexually active

Exclusion Criteria:

* Neurologic disease, on SSRI's,advanced diabetes, non sexually active, mentally incompetent
Ferric Carboxymaltose Versus Iron Sucrose for Treating Anemia in Pregnant Women

This clinical trial aimed to determine whether intravenous ferric carboxymaltose is more useful than iron sucrose for treating anemia in pregnant women.

The main question it aimed to answer was:

Is intravenous ferric carboxymaltose is more useful than iron sucrose for treating iron deficiency anemia in pregnant women.

Sixty pregnant women with iron deficiency anemia were enrolled to one of two intravenous treatments.

* Participants in ferrous carboxymaltose group received a maximum dose of 1000 mg per sitting diluted in 200 ml 0.9% normal saline and administered as an IV infusion over 30 min.
* Participants in iron sucrose group were administered an infusion of 300 mg in 200 ml NS over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week.

The study was conducted after the ethics review committee approval. A total of 60 pregnant women presenting to the department of Obstetrics and Gynecology and fulfilling the eligibility criteria were enrolled in the study after informed consent. Patient's characteristics including age, parity, area of residence, educational status, socioeconomic status and baseline Hb were recorded. All women were administered anthelminthic therapy with tablet mebendazole 100 mg twice daily for three days and given 5 mg Folic acid once daily. Patients were be randomly assigned to group A \& B.

Patients in group A were treated with intravenous ferrous carboxymaltose and group B were given intravenous iron sucrose complex. Parenteral iron therapy was administered under doctor's supervision. The women were then followed up after 3 weeks of completion of therapy. On follow up, hemoglobin and serum ferritin were measured again.

Eligibility Criteria:
Inclusion Criteria:

* 28-34 weeks of gestation
* Iron deficiency anemia (IDA): IDA will be labelled if Hemoglobin is \<10 gm% and serum Ferritin \< 30 ng/ml.

Exclusion Criteria:

* Hepatitis (serum transaminases more than 1.5 times the upper limit of normal) and HIV infection
* serum creatinine level of more than 2.0 mg/dL
* history of allergic reaction to intravenous iron infusion
Outcomes Following Medical or Surgical Management of Endocarditis

Infective endocarditis is a rare disease, and while there have been several large reviews of the incidence of endocarditis in the pediatric patient population, relatively little has been published regarding the short and medium-term outcomes following medical and surgical therapy for this disease. The goal is to compare the outcome for children treated for endocarditis with either medical management or surgery by looking at the success of these two treatment strategies. Another goal is to attempt to identify risk factors for medical management that might identify patients who would be better served by early surgery.

After identification of qualified subjects, the families of surviving patients will be mailed a package containing a cover letter explaining the study, a consent form, an assent form if applicable, a questionnaire (designed to evaluate longer-term outcome measures including the occurrence of recurrent endocarditis, late surgical intervention or the need for re-operations) and a self addressed stamped envelope to be used to return the consents and the questionnaire. The data will then be entered into a database and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* All patients discharged from Children's Healthcare of Atlanta at Egleston with a discharge diagnosis of endocarditis or those who underwent surgery with a preoperative diagnosis of endocarditis.
* Admitted to the hospital between January 1, 1984 - December 31, 2004, inclusive.
* Signed informed consent.

Exclusion Criteria:

* Patients who do not have documented endocarditis based upon microbiology and echocardiography criteria.
Development of Visual Function Evaluation Method (2)

The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent and at screening

Exclusion Criteria:

* Subjects should not have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
* History of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study
* Pregnant women
* Subjects who are judged that continuation of the study is difficult during the study period
* Subjects who are employed by the company sponsoring this study, an organization or institution related to this study
Ganaxolone in Posttraumatic Stress Disorder (PTSD)

This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, 15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress Disorder (PTSD). Up to 120 participants will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. After 6 weeks of randomized treatment all participants will continue for 6 weeks on ganaxolone. The aim of the study is to assess the efficacy of ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to evaluate the safety and tolerability of ganaxolone in the PTSD population.


Eligibility Criteria:
Key Inclusion Criteria:

* Veteran or civilian adult outpatients 18-55 years of age, with primary PTSD as defined by Diagnostic and Statistical manual of Mental Disorders-IV (DSM-IV) for at least 6 months
* Must be in general good health-confirmed by medical history, physical examination, and screening laboratory results
* Negative urine drug screen for drugs of abuse
* Negative urine pregnancy test for females of childbearing potential
* Sexually active participants are required to use a medically acceptable form of birth control

Key Exclusion Criteria

* Clinically unstable medical disease; progressive CNS disorder/disease; history of seizures (except childhood febrile seizure); moderate or severe traumatic brain injury (TBI)
* Females who are pregnant or currently breast feeding
* Current or past psychotic disorder, bipolar Type I disorder, or dementia
* Participants with recent drug abuse or dependency (excluding nicotine and caffeine)
* Participants unwilling to comply with the required alcohol prohibition during the trial
* Current suicidal or homicidal ideation necessitating intervention, and those with a history of suicide attempt in the past 10 years
* Participants with pending litigation related to the traumatic event
* Participants who are unwilling to withhold grapefruit or grapefruit juice for the duration of the study
* Participants receiving psychotherapy without a stable paradigm for at least 3 months
* Non-English speaking participants.
Comparison of Tiotropium Inhalation Capsules and Oxitropium Metered Dose Inhalator (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The objective of this study is to investigate the long-term safety of Ba 79 BR (tiotropium) powder inhalation in patients with COPD using oxitropium bromide (Tersigan) as a comparator. Secondarily, the long-term efficacy of Ba 679 BR is also investigated


Eligibility Criteria:
Inclusion Criteria:

The patients with COPD (chronic bronchitis, emphysema) whose symptoms are stable and who satisfy the following criteria

1. Patients with FEV1.0 of \<=70% of predicted normal and FEV1.0/FVC of \<=70% in the screening test (The FEV1.0 value should also be \<=70% of predicted normal on the starting day of administration (visit 2).)
2. Patients with a smoking history (\<number of cigarettes smoked a day x number of smoking years\> is \>=200.)
3. Male or female patients aged \>=40 years old

Exclusion Criteria:

1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
2. Patients using oral corticosteroid medication at a dose in excess of the equivalent 10 mg/day of prednisolon
3. Patients with glaucoma
4. Patients with symptomatic prostatic hypertrophy
5. Patients with hypersensitivity to anticholinergic drugs or powder inhalants
6. Patients with serious complication who are judged by the investigator to be inappropriate as the subjects of study
7. Patients demonstrating clinically problematic abnormal laboratory test values (general blood test, biochemical test, urinalysis). Those showing Glutamic Oxaloacetic Transaminase (GOT) and Glutamic PyruvicTransaminase (GPT) twice the upper limit of the normal range, bilirubin 1.25 times or creatinine 1.25 times of the upper limit of normal range are excluded.
8. Patients with a recent history of myocardial infarction or heart failure (i.e. within 3 months before the screening test)
9. Patients with arrhythmia requiring the treatment with drugs
10. Patients for whom the concomitant use of beta-blocker cannot be prohibited.
11. Patients who began treatment with an ACE inhibitor within 1 month before the screening test
12. Patients with tuberculosis (currently active) or with definite sequela of tuberculosis
13. Patients with a recent history of carcinoma (excluding basal cell carcinoma) (i.e. within the past 5 years)
14. Patients with a history of cystic fibrosis and bronchiectasis
15. Patients with recent onset of upper airway infection (i.e. within 1 month before the screening test)
16. Patients who have taken an investigational drug within one month or within period six times of half-lives of that drug (whichever is longer) before the screening test.
17. Women who are pregnant or who may become pregnant, or those breast feeding
18. Other than above, those who are judged by the investigator to be inappropriate as the subjects of study
Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma

The purpose of this study is to evaluate the safety and efficacy of Radiotherapy plus Endostar(Recombinant Human Endostatin) in patients with Pediatric Neuroblastoma.

Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. So investigators design Radiotherapy plus Endostar to treat Pediatric Neuroblastoma to research the RR and safety. Investigators believe this treatment regimen may be a new approach to the pediatric neuroblastoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites.
* Life expectancy of greater than 12 months.
* ECOG performance status ≤2
* Diagnostic Imaging MRI and/or CT of the area to be treated within 8 weeks of any treatment. Baseline bone marrow biopsy and bone scan (with 99mTc-diphosphonate or MIBG scan (131I-MIBG or 123I-MIBG) from time of original diagnosis is required.
* Because radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability of the patient or the patient's legal guardian to understand and the willingness to sign a written informed consent document.
* Participants or their legal guardian must sign consent prior to the initiation of radiation therapy.

Exclusion Criteria:

* Patients will be ineligible if any prior therapeutic radiation therapy \> 500 cGy has been delivered.
* Patients will be ineligible if chemotherapy was completed ≥ 1 year from the planned start date of radiation therapy or if the patient is referred for radiation therapy after a relapse following a regimen with chemotherapy alone.
* Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
* Pregnant females are excluded. Women of childbearing age/menstruating must have a negative pregnancy test prior to initiation of radiation therapy.
Sutured vs Sutureless Mesh Fixation for Onlay Ventral Hernia Repair

Comparison beta sutured and suturless mesh fixation for ventral hernia regarding recurrence rates and complications rate

Ventral hernia repair is common procedure with over 250000 repairs each year in the unites states . Most ventral hernias are repaired using tension free type of repair using mesh that bridge the defect and reinforce the abdominal wall .

The mesh fixation technique has impact on recurrence rates,chronic pain and complications rates . Suturless ventral hernia repair with sealing agent fixation proved to be durable with comperable complication profile to other techniques.

Eligibility Criteria:
Inclusion Criteria:

* ventral hernia
* both sexes

Exclusion Criteria:

* obstructed or complicated ventral hernia
* incisional hernia
* recurrent hernia
* multiple ventral hernia
* large hernia more than 5 cm
A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects

This study is a Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects

This study is a pilot phase 1, randomized, double-blind, two-arm, parallel group, single-dose study, which is designed to evaluate the safety, immunogenicity, PK and PD of CT-P41 and EU-approved Prolia in healthy male subjects. Approximately 30 male subjects will be enrolled and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment group, all subjects will receive a single 60 mg dose of either CT P41 or EU-approved Prolia by subcutaneous injection via a PFS on Day 1, followed by 134 days of safety, immunogenicity, PK, and PD measurements.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, between the ages of 28 and 55 years.
* Subject with a BMI between 18.5 and 29.9 kg/m2.
* Subject with albumin-adjusted total serum calcium ≥8.5 mg/dL (≥2.125 mol/L) and serum 25-OH vitamin D ≥20 ng/ml.
* Male subject and their female partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 5 months after the study drug administration.

Exclusion Criteria:

* Subject with a hypersensitivity to any component of denosumab.
* Subject has a history of and/or current known risk factors for hypocalcemia and osteonecrosis of jaw, and any clinically significant illness at investigator's discretion.
* Subject has a history of and/or concurrent use of medications such as an investigational drug, monoclonal antibody, fusion protein, and biologics.
* Subject has a history of and/or concurrent use of any therapy that might significantly affect bone metabolism.
* Subject is vulnerable.
* Subject is not likely to complete the study for whatever reason in the opinion of the Investigator.
A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder

A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically demonstrated BCG-unresponsive, carcinoma in situ (CIS)-containing high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component
* Participants must have CIS to be eligible.
* Predominant histologic component (\> 50%) must be urothelial (transitional cell) carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* Sign of locally advanced disease or metastatic bladder cancer
* Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
* Prior immuno-oncology therapy

Other protocol-defined inclusion/exclusion criteria apply
Are Serum Levels of Vascular Endothelial Growth Factor a Marker for the Early Diagnosis of Ectopic Pregnancy?

OBJECTIVE: This study evaluated serum vascular endothelial growth factor (VEGF) concentrations in women with ectopic pregnancy (EP), abnormal intrauterine pregnancy (aIUP) and normal intrauterine pregnancy (nIUP).

METHODS: This was a prospective, case-control study comparing serum VEGF concentrations among 72 women with ectopic pregnancy (n=35), abnormal IUP (n=15) and normal IUP (n=22) matched for gestational age. For the determination of serum VEGF concentration a solid phase sandwich ELISA was used. Patients were stratified according to serum VEGF above or below 200pg/mL.

RESULTS: The serum level of VEGF was significantly higher in women with ectopic pregnancy (median 211.1 pg/mL; range 5 - 1017.0 pg/mL) than in women with normal IUP (median 5 pg/mL; range 5- 310.6 pg/mL) P \< 0.0001. Serum VEGF concentrations did not show any statistically significant difference between women with aIUP (median 231.9 pg/mL range 5 - 813.7 pg /mL ) and EP (median 211.1 pg/mL range 5 - 1017.0 pg/mL). When cut-off concentrations of 200 pg/mL for VEGF were used, a nIUP could be distinguished from an unviable (EP and aIUP) with a sensitive of 53%, specificity of 90.9%, a positive predictive value of 92.9% and a negative predictive value of 46.5%..

CONCLUSIONS: Serum VEGF could not distinguish between an EP and an aIUP. However, serum VEGF concentrations above 200 pg/mL could discriminate a nIUP from an unviable pregnancy (EP or aIUP) with a PPV of 92.9%.


Eligibility Criteria:
Inclusion Criteria:The inclusion criterion was the presence at transvaginal ultrasound of an extraovarian adnexal mass in women with a suspected ectopic pregnancy (amenorrhea, bleeding and pain) with positive test for beta-hCG.

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Exclusion Criteria:The exclusion criterion was non-tubal ectopic pregnancy (cervical, cesarean scar, ovarian, and abdominal).

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