cyrilzakka/clinical-trials huggingface dataset:
Effect of Tamsulosin on PE Compared With Paroxetine Hydrochloride

A study to compare the effect of tamsulosin versus the effect of paroxetine hydrochloride and the effect of combination of them on PE.

Premature ejaculation is considered the most common male sexual disorder. affecting approximately 4-39 % of men in general community. In 2008, the International Society for Sexual Medicine defined premature ejaculation as a male sexual dysfunction that is characterized by ejaculation that always or nearly always occurs within or before 1 minute of vaginal penetration. Moreover it is associated with presence of distress, frustration, bother, negative personal consequences, depression and the avoidance of sexual intimacy.

Many etiological theories have been included in the pathogenesis of premature ejaculation: neurobiological, psychological, environmental and endocrine factors. So a lot of therapeutic modalities, such as behavioral therapy, selective serotonin reuptake inhibitors (SSRIs), adrenergic alpha 1 antagonists, local anesthetic creams, clomipramine, phosphodiesterase type 5 inhibitors and centrally acting analgesics have been used for the treatment of premature ejaculation.

Previous studies reported that tamsulosin which is alpha blocker agent used as primary therapeutic agent for BPH is effective in the improvement of sexual function. However studies on the effect of tamsulosin on ejaculation reported that tamsulosin had inhibitory effect in the emission phase of ejaculation including decreased ejaculatory volume. So inhibitory effect of tamsulosin on ejaculation may be beneficial to patients suffering from premature ejaculation.

Historically, PE was considered psychological problem and was treated by behavioral treatment and psychotherapy but there is pharmacological studies increase the evidence that PE may be related to decreased serotonergic neurotransmission. So selective serotonin reuptake inhibitors (SSRIs ) such as : paroxetine, fluoxetine, dapoxetine, and sertraline are among the recommended pharmacological treatments for treating PE. But there is no universal agreement on the type, the dose and administration protocol.

So a study is needed to compare the value of combination therapy of both tamsulosin and paroxetine with the value of single therapy of either of them and consider Intravaginal Ejaculatory Latency Time (IELT) and ejaculatory control ability of patients after using tamsulosin and paroxetine.

Eligibility Criteria:
Inclusion Criteria:

* Married, sexually active patients with PE will be included with ages ranging from 20 to 60 years.

Exclusion Criteria:

* Patients suffering from erectile dysfunction, DM, HTN, neurological disorders and psychological disorders.
Controlled Donors After Circulatory Death and Brain Death: a Multicenter Study of Transfusion, One-year Graft Survival and Mortality. Cohort Study,

RBC requirement ein DBD and DCD liver transplants

Background: Controlled donation after cardiac circulatory death (cDCD) is accepted to expand the donor pool for liver transplantation (LT). However, transfusion requirements and perioperative outcomes should be elucidated. The aims of this multicentre study are to assess the red blood cell (RBC) transfusions, one-year graft and patient survival after LT with cDCD compared to donors after brain dead (DBD).

Methods: 591 LT patients conducted in ten centers during 2019 were reviewed. Thromboelastometry was used to manage coagulation and blood product transfusion in all centres. Normothermic regional perfusion was the standard technique for organ recovery.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing LT

Exclusion Criteria:

* acute liver failure
Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer

The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50
* Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
* Prior chemotherapy is permitted with no limit on the number of prior regimens
* Two weeks or more have elapsed since last chemotherapy or radiation treatment
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
* Is female, ≥ 18 yrs of age
* Protocol defined appropriate laboratory values
* Negative pregnancy test within 7 calendar days prior to registration
* Has signed a patient informed consent

Exclusion Criteria:

* Had prior treatment with ixabepilone or other epothilones
* Has HER2+ disease
* Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events \[NCI CTCAE\] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)
* Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
* Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
* Has peripheral neuropathy \> Grade 1
* Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible
* Is pregnant or breast feeding
Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya

The aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence. This pilot study will provide data on the efficacy trends, acceptability and feasibility of our IPT intervention and will generate preliminary findings for an R01-funded intervention to test the intervention's efficacy for remediating the effects of GBV trauma on mental health and HIV-related outcomes.

Hypothesis 1: IPT+ TAU will be more effective for reduction of depression and PTSD than TAU alone.

Hypothesis 2: IPT+TAU will be acceptable and feasible.

We will use a parallel design with FACES Treatment as Usual (TAU) control to provide IPT once per week for twelve weeks to HIV+GBV+ women meeting CIDI diagnostic criteria for depression (MDD, dysthymia, minor depression) and PTSD secondary to GBV. Blocked randomization will be used to evenly distribute 120 participants to (1) IPT + TAU or (2) TAU for 12 weeks. The TAU group will be offered IPT treatment following the initial 12 week trial. Thus, all study subjects will receive TAU throughout the study and they will all receive IPT in either the first or second half of the study. My research team at FACES will be recruited for IPT training as potential therapists in the IPT pilot. A run-in study design will be used, assigning one training case apiece to each of the 8 therapists to practice IPT skills. Both IPT + TAU and TAU groups will be measured at baseline and weeks 12, 24 and 36 by blinded assessment. At FACES, TAU resources for HIV+GBV+ women include medical professionals, counseling, community elders, church leaders, police, and a pro-bono legal aid, all of who have all been involved with past FACES GBV interventions.

Eligibility Criteria:
Inclusion Criteria:

* .(1) HIV+ women enrolled at FACES-Kisumu; (2) Diagnosis with depression (MDD, dysthymia, minor depression) and PTSD secondary to GBV\* on the CIDI; (3) Ability to attend weekly therapy sessions and repeated measures; (4) Age greater than 18 years; (5) Ability to give informed consent.

Exclusion Criteria:

* (1) Cognitive dysfunction requiring a higher level of care or compromising ability to participate in IPT\*\*; (2) severe thought or mood disorder symptoms requiring a higher level of care or interfering with ability to participate in IPT; (3) current drug and alcohol dependence requiring substance use treatment. Although PTSD is associated with substance abuse in EuroAmerican populations, a recent study of 5175 FACES patients found that over 80% of this LMIC population use no alcohol.
A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults

The purpose of this study is to evaluate the efficacy and safety of the study drug, IPN10200, and to assess how well it works when compared with placebo in treating Cervical Dystonia (CD) in adults.

CD can cause a series of abnormalities and symptoms in the head and neck that can lead to neck pain and stiffness, and headaches. CD is believed to involve deep parts within the brain that control movement, but genetic factors, environmental factors, and abnormalities in the brain may also play a role.

The usual treatment for CD includes injecting BoNT into the affected muscles, but the treatment only lasts about 3 months. IPN10200 is designed to last for a longer period.

The study will consist of two periods:

1. A Screening Period of up to 4 weeks (28 days) to assess whether a participant can take part in the study and requires at least one visit.
2. A Treatment Period of 36 weeks.

On Day 1 of the treatment period, participants will receive either IPN10200 Dose A or Dose B (additional participants may receive IPN10200 Dose C) of the study drug, or placebo distributed into different muscles in the head, neck and shoulders. Participants may continue some other medications, but details need to be recorded.

There will be 10 visits to the clinic in person and one remote visits (phone call) (12 visits to the clinic for participants who receive Dose C). Participants will undergo blood samplings, urine collections, physical/neurological examinations, and clinical evaluations. Participants will also need to complete questionnaires throughout the study.

The total study duration for a participant will be up to 40 weeks (approximately 9 months).


Eligibility Criteria:
Inclusion Criteria:

1. A clinical diagnosis of isolated Cervical Dystonia (CD) (idiopathic) characterized by dystonic symptoms localised to the head, neck, and shoulder areas with at least moderate severity at Screening and Baseline (Day 1) defined as:

   * (a) Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score ≥20
   * (b) TWSTRS-Severity subscale score ≥15
   * (c) TWSTRS-Disability subscale score ≥3
   * (d) TWSTRS-Pain subscale score ≥ 1
2. Treatment naïve or non-naïve to BoNT therapy for CD

Exclusion Criteria:

1. Participants presenting with a swallowing disorder of any origin which might be exacerbated by BoNT treatment, such as:

   * (a) Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowing difficulties and requiring a change in diet.
2. Predominant anterocollis.
3. Predominant retrocollis.
4. Traumatic torticollis or tardive torticollis.
5. Marked limitation on passive range of motion that suggests cervical contractures or structural abnormality.
Pilot Study to Determine Safety and Efficacy of Orbital Injections of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease (TED)

This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.


Eligibility Criteria:
Inclusion Criteria:

* Male or Non pregnant female
* Symptomatic exophthalmos
* Inactive Thyroid Eye Disease
* Signed informed consent

Exclusion Criteria:

* Known hypersensitivity to study drugs
* Treatment with an investigational agent within 30 days of first dose
* History of Thyroid Eye Disease less than 6 months
* Previous decompression surgery
* Glaucoma
NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease

Previously, studies have shown that children of women with thyroid autoantibodies experience more birth complications and poorer health in their first days. Studies have also shown later signs of cognitive developmental challenges (risk of attention deficit/hyperactivity problems) among children of mothers with autoimmune thyroid disease and/or subclinical hypothyroidism. In Denmark there is no formalized screening or treatment of subclinical thyroid disease - with or without Thyroid Peroxidase Antibodies (TPO-antibodies) - among pregnant women.

The hypothesis of this study is that the offspring of women with subclinical thyroid disease have a mitochondria-dysfunction which leads to more complications during birth, poorer health and well-being in the early childhood. The investigators will test this by recruiting mothers by a blood sample in the third trimester of pregnancy, screen the cord blood at birth and later on test the children with Bayley test two times in the early childhood.

Prior to a planned caesarean section, maternal blood samples are drawn and at the cesarean, cord blood samples are drawn, when the cord is clamped and cut. Thyrotropin, free T3, free T4, anti-TPO and lipids are measured on maternal as well as cord samples. Flow cytometry is performed to measure mitochondrial function. At age 6 months and 15 months the child´s development is evaluated by the Bayley-III test.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy, clinically healthy

Exclusion Criteria:

* Twin-pregnancy, metabolic disorder, medication or other diseases with a potential adverse impact on the pregnancy and fetus
Assessing the Role of Mitochondrial Dysfunction in Primary Progressive Multiple Sclerosis

The purpose of this project is to study genetic determinants of mitochondrial impairment in primary progressive multiple sclerosis. Specific aims are: 1) identify mitochondrial-related pathways, inherited and somatic mitochondrial DNA mutations associated to primary progressive multiple sclerosis, 2) functionally assess the identified genetic alterations.

Multiple Sclerosis is a major cause of neurological disability, with a high socio-economic impact that increases as disability progresses. Effective treatment of primary progressive multiple sclerosis is still an unmet need and the underlying neurodegenerative processes have to be fully investigated. The purpose of this project is to study genetic determinants of mitochondrial impairment in primary progressive multiple sclerosis. Altered mitochondrial pathways will be investigate, as well as inherited and tissue-specific somatic mitochondrial variations associated with primary progressive multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by primary progressive or relapsing remitting multiple sclerosis
* Patient able to provide informed consent

Exclusion Criteria:

* Individuals with \< 18 years
* Patients not affected by primary progressive or relapsing remitting multiple sclerosis
Impact of Team-Based Training on Compliance and Physical Fitness in Firefighters

Research Objectives: This study aims to develop a team-based training model specifically tailored for firefighters, focusing on improving their cardiovascular fitness, physical attributes, and fostering sustainable health behaviors. The ultimate goal is to reduce the risk of injuries associated with the physically demanding tasks they perform during their duties.

Research Hypotheses:

Firefighters participating in the team-based training model will demonstrate significant improvements in key fitness parameters, such as cardiorespiratory fitness, muscular strength, endurance, and body composition compared to those engaged in traditional training.

The team-based approach will enhance adherence to physical training among firefighters, leading to more consistent participation and improved health outcomes.

This clinical study is a randomized controlled trial that involved 42 firefighters who were divided into two groups: one receiving a team-based training intervention for six months and the other continuing with conventional exercises. The team training incorporated aerobic, resistance, and functional exercises, emphasizing teamwork and peer support to motivate participants. Key fitness measures, including cardiorespiratory fitness, strength, endurance, flexibility, and body mass index (BMI), were assessed before and after the intervention.

The study hypothesized that the team-based training model would not only enhance fitness levels but also improve adherence to training routines among firefighters, ultimately contributing to better health and safety during their demanding work.


Eligibility Criteria:
Inclusion Criteria:

Firefighters aged 18 to 50 years. Currently active duty within the selected brigade. Capable of performing physically demanding tasks without medical restrictions. Written informed consent provided by participants.

Exclusion Criteria:

Firefighters with any cardiovascular, respiratory, or musculoskeletal conditions that could hinder participation or affect fitness outcomes.

Individuals recovering from recent injuries or surgeries. Firefighters enrolled in external training programs that may impact baseline health assessments.

Any participant who refuses to provide informed consent.
Effects on Emphathy in Physiotherapy Students After Simulation as an Active Method for Learning the Clinical Enterview

The aim of the main study is to find out the effects on empathy in physiotherapy students after role playing in the learning of the clinical history.

Thirty-one first-year physiotherapy students will carry out the role-playing methodology to learn how to take a clinical history in physiotherapy.

Before and after the realization, they will be measured by means of a validated questionnaire in Spanish, the language in which they study, the variable of empathy.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are studying the first year of Physiotherapy at the Complutense University of Madrid and wish to participate in the study.

Exclusion Criteria:

* Students who do not wish to participate in the study.
Effect of Electromyostimulation on Bone

Although there is some evidence that whole body electromyostimulation(WB-EMS) affect bone via its acute and longitudinal effects on muscle mass and strength, the corresponding impact on bone density and falls in older adults has not been assessed yet. The investigators hypothesize that WB-EMS significantly affects bone parameters as assessed by DXA, and significantly reduce fall rate and ratio in a cohort of frail elderly women.


Eligibility Criteria:
Inclusion Criteria:

* female gender
* 70 years and older
* osteopenia according to WHO
* BMI \< 24 kg/m2
* living independently in the area of Erlangen-Nurnberg

Exclusion Criteria:

* medication or diseases affecting bone metabolism (including HRT)
* \> 1 hour/week of exercise
* epilepsy, grave neurologic disturbances,
* cardiac pacemaker, grave circulatory disorders,
* abdomen/groin hernia,
* tuberculosis,
* cancer,
* inflammable diseases,
* bleeding tendencies,
Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction

Age is no longer an absolute contraindication to cardiac surgery therefore there is often need for combined interventions (double valve repair/replacement, or coronary artery bypass graft and valve repair/replacement) with relative prolongation of cardiopulmonary bypass time. Prolonged cardiopulmonary bypass use causes an increase in the inflammatory response, and on the other a need for blood reinfusion and therefore lipid microemboli from the operative field. The clinical consequences for patients are post-operative delirium and post-operative cognitive impairment.

These two neurological complications involve up to 45% of elderly patients undergoing cardiac surgery and have a significant impact on quality of life, hospitalization and mortality in the short and long term. The Remowell 2 oxygenator system has demonstrated in preliminary studies that, compared to the gold standard Inspire oxygenator, it can guarantee a significant reduction of hemodilution, inflammatory systemic response and embolization of lipid microemboli and leukocytes. In light of these considerations, it is possible to formulate the hypothesis that the use of the Remowell 2 device can contribute to significantly reducing the onset of post-operative delirium and cognitive impairment. The present study is designed to validate this hypothesis in a randomized controlled scenario.


Eligibility Criteria:
Inclusion Criteria:

1. Signature of informed consent for participation in the study
2. Age ≥65 years
3. Patients undergoing cardiac surgery of:

   1. coronary artery bypass graft and concomitant valve replacement/repair OR
   2. double valve replacement/repair

Exclusion Criteria:

1. Any documented history of cognitive impairment estimated as a mini mental state examination \< 24 points
2. Patients who need blood prime in the cardiopulmonary bypass circuit
3. Chronic coagulopathies ( international normalized ratio \> 2 in patients without anticoagulant treatment)
4. End stage renal disease on dialysis treatment
5. Previous cerebrovascular accident
6. Active cancer or immunological diseases
7. Liver cirrhosis (platelets \<100.000/uL)
8. Decompensated diabetes
9. Severe preoperative anemia (hemoglobin \<8 g/dl).
Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)

The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older.
* Histological or cytological confirmation of malignant disease.
* Karnofsky index \>= 50%
* Naïve to chemotherapy (First Cycle of chemotherapy IV with moderate or high emetic risk administered during Day 1 of the study, according to modification of the classification of Paul Hesketh's schema published on Annals of Oncology 17: 20-28, 2006 (Appendix 3).
* Patients that voluntarily sign the consent form.

Exclusion Criteria:

* Pregnancy or suspected.
* Patients during breast feeding.
* Inability to understand or cooperate with the study procedures.
* Received any investigational drugs within 30 days before study entry.
* Received any drug with potential anti-emetic efficacy within 24 hours prior to the beginning of the treatment
* Seizure disorders requiring anticonvulsant medication.
* Persistent vomiting due to any organic etiology.
* Experienced any vomiting, nausea or retching, in the 24 hours prior to chemotherapy.
* Any systemic disease different to base disease
* Known current or history of drug or alcohol abuse
* Gastric outlet or intestinal obstruction